The success of the citizen suit: protecting consumers from inaccurate food labeling by amending the Federal Food, Drug, and Cosmetic Act.

Science.gov (United States)

Springer, James

2013-01-01

The Federal Food, Drug, and Cosmetic Act ("FDCA"), amended in 1990 by the Nutrition Education and Labeling Act ("NLEA"), established a national framework for the administration and promulgation of uniform food labeling standards. Specifically, the NLEA created affirmative obligations for the food--requiring detailed disclosure of food content and strict adherence to regulations governing the use of health and nutritional claims on food packaging. To accomplish these goals, Congress tasked the Food and Drug Administration ("FDA") with the sole responsibility of the enforcement of these new requirements. Under the statutory framework of the FDCA, the United States Supreme Court ("Court") has held that there is no private right of action, of which extended to the enforcement of NLEA standards. This interpretation has left individuals with no federal outlet for relief in the enforcement of federal food labeling standards. Adherence to this interpretation is especially concerning when the FDA currently faces exponential growth in administrative responsibilities while simultaneously experiencing employment reduction, a $206 million "Sequester," and a recent government-wide shutdown. As a result, the American people are left to depend on an Agency that is struggling with drastic resource reduction while being accountable for ever increasing enforcement responsibilities. To ensure consumer protection, this Article argues that Congress should amend the FDCA to include a citizen suit provision in order to provide individuals with a right of private action for the enforcement of NLEA standards. Borrowing from the successes realized under similar citizen suit provisions found in environmental legislation, this Article argues that a citizen suit provision is amendable to the FDCA and would relieve fiscal pressures, strengthen the current enforcement framework of the FDCA, encourage more robust enforcement by the FDA and states, and ensure uniform interpretation of NLEA

76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

Science.gov (United States)

2011-06-21

... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act... the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug... statutory definitions for these terms set forth in sections 201(g) and 201(h) of the Federal Food, Drug, and...

Food, drugs, and droods: a historical consideration of definitions and categories in American food and drug law.

Science.gov (United States)

Grossman, Lewis A

2008-07-01

This Article explores the evolution and interaction of the legal and cultural categories "food" and "drug" from the late nineteenth century to the present. The federal statutory definitions of "food" and "drug" have always been ambiguous and plastic, providing the FDA with significant regulatory flexibility. Nevertheless, the agency is not necessarily free to interpret the definitions however it chooses. "Food" and "drug" are not only product classes defined by food and drug law, but also fundamental cultural concepts. This Article demonstrates that the FDA, as well as Congress and the courts, have operated within a constraining cultural matrix that has limited their freedom to impose their preferred understandings of these categories on American society. Nonetheless, history also provides ample evidence that lawmakers possess substantial power to mold the legal categories of "food" and "drug" so as to advance desired policies. One explanation for this regulatory flexibility in the face of deep-seated cultural conceptions is the indeterminate nature of the extralegal notions of "food" and "drug." The terms, as commonly understood, embrace nebulous, overlapping, and constantly evolving realms. Moreover, the relationship between culture and law is not a one-way street with respect to these categories. Although the regulatory apparatus has always had to take into account the extralegal understandings of "food" and "drug," the law in turn has exerted significant influence over their meaning in broader culture.

77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

Science.gov (United States)

2012-02-23

...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

Food-drug interactions

DEFF Research Database (Denmark)

Schmidt, Lars E; Dalhoff, Kim

2002-01-01

Interactions between food and drugs may inadvertently reduce or increase the drug effect. The majority of clinically relevant food-drug interactions are caused by food-induced changes in the bioavailability of the drug. Since the bioavailability and clinical effect of most drugs are correlated......, the bioavailability is an important pharmacokinetic effect parameter. However, in order to evaluate the clinical relevance of a food-drug interaction, the impact of food intake on the clinical effect of the drug has to be quantified as well. As a result of quality review in healthcare systems, healthcare providers...... are increasingly required to develop methods for identifying and preventing adverse food-drug interactions. In this review of original literature, we have tried to provide both pharmacokinetic and clinical effect parameters of clinically relevant food-drug interactions. The most important interactions are those...

Food-Drug Interactions

Directory of Open Access Journals (Sweden)

Arshad Yar Khan

2011-03-01

Full Text Available The effect of drug on a person may be different than expected because that drug interacts with another drug the person is taking (drug-drug interaction, food, beverages, dietary supplements the person is consuming (drug-nutrient/food interaction or another disease the person has (drug-disease interaction. A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. These interactions may occur out of accidental misuse or due to lack of knowledge about the active ingredients involved in the relevant substances. Regarding food-drug interactions physicians and pharmacists recognize that some foods and drugs, when taken simultaneously, can alter the body's ability to utilize a particular food or drug, or cause serious side effects. Clinically significant drug interactions, which pose potential harm to the patient, may result from changes in pharmaceutical, pharmacokinetic, or pharmacodynamic properties. Some may be taken advantage of, to the benefit of patients, but more commonly drug interactions result in adverse drug events. Therefore it is advisable for patients to follow the physician and doctors instructions to obtain maximum benefits with least fooddrug interactions. The literature survey was conducted by extracting data from different review and original articles on general or specific drug interactions with food. This review gives information about various interactions between different foods and drugs and will help physicians and pharmacists prescribe drugs cautiously with only suitable food supplement to get maximum benefit for the patient.

75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

Science.gov (United States)

2010-04-29

...] Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for... the Internet. To receive ``Draft Guidance for Industry and Food and Drug Administration Staff; User... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and...

78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

Science.gov (United States)

2013-02-08

...] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic...

78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

Science.gov (United States)

2013-12-04

...] Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers... the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and...

78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

Science.gov (United States)

2013-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug...

76 FR 47210 - Notices of Filing of Petitions for Food Additives and Color Additives; Relocation in the Federal...

Science.gov (United States)

2011-08-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0518] Notices of Filing of Petitions for Food Additives and Color Additives; Relocation in the Federal Register...) is notifying the public that notices of filing of petitions for food additives and color additives...

FOOD SECURITY PROBLEMS OF THE RUSSIAN FEDERATION

Directory of Open Access Journals (Sweden)

Natalia Polyanskaya

2015-09-01

Full Text Available The article describes the concepts and factors of food security and food sovereignty of the Russian Federation. The composition of the consumer basket, the most significant of its components, and based on threshold values of self-sufficiency is calculated in the dynamics of the prevalence of food independence. The groups of products, which are in the country to be at a level below the thresholds, regulated by the food security doctrine of the Russian Federation. Identified the possible General trend of development of agricultural production in the country.

76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

Science.gov (United States)

2011-12-30

...] Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. SUMMARY: As part of the Transparency...

75 FR 22809 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

Science.gov (United States)

2010-04-30

... time for related training in Federal and federally-regulated workplace drug testing programs and will... related training in Federal and federally-regulated workplace drug testing programs, including HHS... DEPARTMENT OF HEALTH AND HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing...

FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

Science.gov (United States)

James, J S

1998-03-06

The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

Got junk? The federal role in regulating "competitive" foods.

Science.gov (United States)

Salinsky, Eileen

2009-12-11

A wide variety of food and beverage items are available in schools in addition to the school meals provided through the National School Lunch Program and School Breakfast Program. A long-standing source of controversy, the need for stronger federal restrictions on foods that compete with school meals is again under debate. This issue brief examines the availability and consumption of competitive foods, explores the regulation of these foods at the federal level, considers trends in state and local restrictions, and summarizes perceived barriers to improving the nutritional quality of competitive food options.

77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

Science.gov (United States)

2012-04-06

...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

75 FR 59105 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug Testing...

Science.gov (United States)

2010-09-27

... 2105-AE03 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug... the Federal workplace drug testing program but also pointed out that ``* * * the Department of.... Executive Order 12866 and Regulatory Flexibility Act This Interim Final Rule is not significant for purposes...

Anticoagulant Medicine: Potential for Drug-Food Interactions

Science.gov (United States)

... Medications Anticoagulants and Drug-Food Interactions Anticoagulants and Drug-Food Interactions Make an Appointment Ask a Question Refer Patient ... Jewish Health wants you to be aware these drug-food interactions when taking anticoagulant medicine. Ask your health care ...

Oral chemotherapy: food-drug interactions

Directory of Open Access Journals (Sweden)

Sara Santana Martínez

2015-07-01

Full Text Available Introduction: oral chemotherapy is increasingly used in Oncology. It has important advantages. such as patient comfort. but it also brings new challenges which did not exist with the intravenous therapy. Some of these drugs have interactions with food. leading to changes in their bioavailability. As they are drugs of narrow therapeutic margin. this can lead to alterations in their efficacy and/or toxicity. Objectives: A. Assessing the level of knowledge on the administration of oral cytostatics that present restrictions with meals (drugs that have to be taken with/without food among the outpatients. B. Minimizing the incorrect administration and the risk of food-drug interactions. providing patients with information as to how and when drugs have to be administrated. Methods: once the oral cytostatics with food restrictions were identified. we asked the patients in treatment about the information they had received from the doctor and the way they were taking the medication. We provided those who were taking the drug incorrectly with the right information. In the following visit. it was confirmed if the patients that had been previously taking the cytostatic incorrectly. were taking them in a correct way (intervention accepted/not accepted. Results and conclusions: 40% of the patients interviewed used to take the drug incorrectly. We detected a great diversity depending on the dispensed drug. 95% of the 39 interventions made were accepted. The data obtained suggest the need to reinforce the information that the patient receives. It is important to make sure that the patient understands how and when the oral cytostatic should be administered

Federal laws needed for food irradiation

International Nuclear Information System (INIS)

Benson, D.

1987-01-01

The proposed use of irradiation in food processing is drawing considerable attention to the Australian irradiation industry that has operated safely for almost 30 years. A recent inquiry by the Australian Consumers Association concluded that food irradiation should only be allowed if strong federal laws are implemented to ensure the safety of consumers and environment. At present, Australian irradiation plants are confined to sterilising or reducing health risks associated with products not for human consumption

75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

Science.gov (United States)

2010-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

The history and contemporary challenges of the US Food and Drug Administration.

Science.gov (United States)

Borchers, Andrea T; Hagie, Frank; Keen, Carl L; Gershwin, M Eric

2007-01-01

The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide. The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs. Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further. The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation. As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces

Developing a molecular roadmap of drug-food interactions.

Directory of Open Access Journals (Sweden)

Kasper Jensen

2015-02-01

Full Text Available Recent research has demonstrated that consumption of food -especially fruits and vegetables- can alter the effects of drugs by interfering either with their pharmacokinetic or pharmacodynamic processes. Despite the recognition of such drug-food associations as an important element for successful therapeutic interventions, a systematic approach for identifying, predicting and preventing potential interactions between food and marketed or novel drugs is not yet available. The overall objective of this work was to sketch a comprehensive picture of the interference of ∼ 4,000 dietary components present in ∼1800 plant-based foods with the pharmacokinetics and pharmacodynamics processes of medicine, with the purpose of elucidating the molecular mechanisms involved. By employing a systems chemical biology approach that integrates data from the scientific literature and online databases, we gained a global view of the associations between diet and dietary molecules with drug targets, metabolic enzymes, drug transporters and carriers currently deposited in DrugBank. Moreover, we identified disease areas and drug targets that are most prone to the negative effects of drug-food interactions, showcasing a platform for making recommendations in relation to foods that should be avoided under certain medications. Lastly, by investigating the correlation of gene expression signatures of foods and drugs we were able to generate a completely novel drug-diet interactome map.

Drug specificity in drug versus food choice in male rats.

Science.gov (United States)

Tunstall, Brendan J; Riley, Anthony L; Kearns, David N

2014-08-01

Although different classes of drug differ in their mechanisms of reinforcement and effects on behavior, little research has focused on differences in self-administration behaviors maintained by users of these drugs. Persistent drug choice despite available reinforcement alternatives has been proposed to model behavior relevant to addiction. The present study used a within-subjects procedure, where male rats (Long-Evans, N = 16) were given a choice between cocaine (1.0 mg/kg/infusion) and food (a single 45-mg grain pellet) or between heroin (0.02 mg/kg/infusion) and food in separate phases (drug order counterbalanced). All rats were initially trained to self-administer each drug, and the doses used were based on previous studies showing that small subsets of rats tend to prefer drug over food reinforcement. The goal of the present study was to determine whether rats that prefer cocaine would also prefer heroin. Choice sessions consisted of 2 forced-choice trials with each reinforcer, followed by 14 free-choice trials (all trials separated by 10-min intertrial interval). Replicating previous results, small subsets of rats preferred either cocaine (5 of the 16 rats) or heroin (2 of the 16 rats) to the food alternative. Although 1 of the 16 rats demonstrated a preference for both cocaine and heroin to the food alternative, there was no relationship between degree of cocaine and heroin preference in individual rats. The substance-specific pattern of drug preference observed suggests that at least in this animal model, the tendencies to prefer cocaine or heroin in preference to a nondrug alternative are distinct behavioral phenomena.

Drugs to be Discontinued

Data.gov (United States)

U.S. Department of Health & Human Services — Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and...

The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine.

Science.gov (United States)

Wang, Bo; Studdert, David M; Sarpatwari, Ameet; Franklin, Jessica M; Landon, Joan; Kesselheim, Aaron S

2017-01-01

In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa). In a series of settlements between 2008 and 2010, Eli Lilly paid $1.4 billion to the federal government and over $290 million to state governments. We examined the effect of these settlements on off-label prescribing of this medication, taking advantage of geographical differences in states' involvement in the investigations and the timing of the settlements. However, we did not find a reduction in off-label prescribing; rather, there were no prescribing changes among states that joined the federal investigation, those that pursued independent state investigations, and states that pursued no investigations at all. Since the settlements of state investigations of off-label prescribing do not appear to significantly impact prescribing rates, policymakers should consider alternate ways of reducing the prevalence of non-evidence-based off-label use to complement their ongoing investigations.

76 FR 25358 - 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public...

Science.gov (United States)

2011-05-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food...

Developing a Molecular Roadmap of Drug-Food Interactions

DEFF Research Database (Denmark)

Jensen, Kasper; Ni, Yueqiong; Panagiotou, Gianni

2015-01-01

therapeutic interventions, a systematic approach for identifying, predicting and preventing potential interactions between food and marketed or novel drugs is not yet available. The overall objective of this work was to sketch a comprehensive picture of the interference of ∼ 4,000 dietary components present...... view of the associations between diet and dietary molecules with drug targets, metabolic enzymes, drug transporters and carriers currently deposited in Drug-Bank. Moreover, we identified disease areas and drug targets that are most prone to the negative effects of drug-food interactions, showcasing......Recent research has demonstrated that consumption of food -especially fruits and vegetables-can alter the effects of drugs by interfering either with their pharmacokinetic or pharmacodynamic processes. Despite the recognition of such drug-food associations as an important element for successful...

76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

Science.gov (United States)

2011-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

Implications of the Food, Drug, and Cosmetic Act on the quality assurance of radiopharmaceuticals used in the United States

International Nuclear Information System (INIS)

Kishore, R.; Sheinin, E.B.

1990-01-01

The drug sections of the Federal Food, Drug, and Cosmetic Act (Title 21 U.S.C.) are intended to assure the consumer that drugs are safe and effective for their intended use. The Act requires that new drugs be approved by the FDA before they go on the market. The regulations for the new drug review process, are contained in the Code of Federal Regulations (CFR) Title 21, sections 312 for Investigational New Drugs (INDs), 314 for New Drug Applications (NDAs). Section 361 deals with radioactive drugs for certain research (RDR) uses. The regulations require that sufficient information be provided on the acceptable limits and the analytical methods used for the assurance of the identity, strength, quality, purity and the stability of the new drug as well as the raw materials used in the preparation of the new drug. The impact of the Act on the control of radiopharmaceutical products will be discussed

76 FR 50741 - 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality...

Science.gov (United States)

2011-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality and...: Notice of public conference. The Food and Drug Administration (FDA), in cosponsorship with Parenteral...

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations.

Science.gov (United States)

Allan, M C

1992-01-01

To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction ;of the components

1991 annual report of the Karlsruhe Federal Food Research Institute

International Nuclear Information System (INIS)

1992-01-01

The Federal Food Research Institute does research in the field of nutrition, food and household sciences as well as in related special fields. Among its working priorities are the determination of foreign matter and radionuclides in food as well as food preservation by means of irradiation including dosimetry. The results of those priorities are represented. (orig./MG) [de

Regulations And Control Of Food And Drugs

International Nuclear Information System (INIS)

Osuide, G.E.; Director General, National Agency For Food And Drugs Administration And Control, Federal Secretariat, Ikoyi, Lagos, Nigeria.

1996-01-01

Effective control of processed food and medicines is crucial for the maintenance of public health. Issues of wholesomeness, quality, efficacy and safety are of paramount concern to both consumers and regulatory agencies alike. Laws and regulatory are put in in place to ensure minimum standards of practice by the various operators in the food and pharmaceutical sub-sectors, such as will guarantee that the regulated products (food, drugs, cosmetics, medical devices, chemicals and bottled water) they deal in satisfy all the parameters of quality, wholesomeness, efficacy and safety. National Agency for Food and Drug Administration and Control (NAFDAC) was established to enforce all relevant laws and regulations on food and drugs among other-regulated products. NAFDAC has put in place appropriate administrative structures and procedures in its efforts to fulfill its mandate. Finally, the agency is in the process of extending its regulatory and control activities to cover irradiated food products in order to safeguard public health

77 FR 5171 - Further Amendments to General Regulations of the Food and Drug Administration to Incorporate...

Science.gov (United States)

2012-02-02

... Advertising Act (FCLAA) (15 U.S.C. 1333) as amended by the Tobacco Control Act, and under section 3 of the... that provide for a part 16 hearing. IV. Analysis of Impacts A. Introduction and Summary FDA has... introduction into interstate commerce. Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to...

21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a) The...

21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. (a) The Administrator...

Investigating How to Align Schools' Marketing Environments With Federal Standards for Competitive Foods.

Science.gov (United States)

Polacsek, Michele; O'Brien, Liam M; Pratt, Elizabeth; Whatley-Blum, Janet; Adler, Sabrina

2017-03-01

Limiting food and beverage marketing to children is a promising approach to influence children's nutrition behavior. School-based marketing influences nutrition behavior and studies have consistently found marketing for nonnutritious foods and beverages in schools. No studies have examined the resources necessary to align school marketing environments with federal school nutrition standards. The purpose of this study was to determine how to improve school marketing environments so that they align with new federal competitive food nutrition standards. We assessed food marketing environments in 3 Portland, Maine schools using the Food and Beverage Marketing Survey (FBMS) and provided technical assistance to bring their marketing environments into conformity with the federal competitive food regulations, tracking resources and strategies for marketing removal. Noncompliant marketing was significantly reduced pre- to postintervention. Intervention strategies were facilitated by the School Health Coordinator and school-based wellness teams. Low monetary resources were required to remove marketing not compliant with federal nutrition standards for foods sold in schools. Several key challenges remain to sustain efforts. This study provides timely information for policymakers to support crafting policies that address the realities of school nutrition environments and universal enforcement challenges. © 2017, American School Health Association.

Food, physiology and drug delivery.

Science.gov (United States)

Varum, F J O; Hatton, G B; Basit, A W

2013-12-05

Gastrointestinal physiology is dynamic and complex at the best of times, and a multitude of known variables can affect the overall bioavailability of drugs delivered via the oral route. Yet while the influences of food and beverage intake as just two of these variables on oral drug delivery have been extensively documented in the wider literature, specific information on their effects remains sporadic, and is not so much contextually reviewed. Food co-ingestion with oral dosage forms can mediate several changes to drug bioavailability, yet the precise mechanisms underlying this have yet to be fully elucidated. Likewise, the often detrimental effects of alcohol (ethanol) on dosage form performance have been widely observed experimentally, but knowledge of which has only moderately impacted on clinical practice. Here, we attempt to piece together the available subject matter relating to the influences of both solid and liquid foodstuffs on the gastrointestinal milieu and the implications for oral drug delivery, with particular emphasis on the behaviour of modified-release dosage forms, formulation robustness and drug absorption. Providing better insight into these influences, and exemplifying cases where formulations have been developed or modified to circumvent their associated problems, can help to appropriately direct the design of future in vitro digestive modelling systems as well as oral dosage forms resilient to these effects. Moreover, this will help to better our understanding of the impact of food and alcohol intake on normal gut behaviour and function. Copyright © 2013 Elsevier B.V. All rights reserved.

Conseptual framework of ensuring food security in the Ural federal district

Directory of Open Access Journals (Sweden)

Aleksandr Samvelovich Beletskiy

2011-12-01

Full Text Available The paper reviews the risks and threats to food security of the Ural Federal District which can significantly reduce its the level. The most significant risks are grouped according to the following classification: macroeconomic, technological, climatic, agro-ecological and foreign trade risks. The main directions of economic policy of the Ural Federal District in the area of food security are defined. Particular attention is paid to the improvement of economic and physical availability of food for all groups of population and to the problems of formation of the state material reserves and food safety. Strategic development priorities in the field of agricultural and fishery products, raw materials and food, sustainable development of rural areas in the field of foreign policy are formulated. Conceptual bases for the implementation mechanism of economic policies to ensure food security in the region are suggested.

77 FR 72254 - New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food

Science.gov (United States)

2012-12-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 500, 520, 522, 524, 529, 556, and 558 [Docket No. FDA-2012-N-1067] RIN 0910-AG17 New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food AGENCY: Food and Drug Administration, HHS. ACTION...

21 CFR 589.1001 - Propylene glycol in or on cat food.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Propylene glycol in or on cat food. 589.1001... or on cat food. The Food and Drug Administration has determined that propylene glycol in or on cat... on cat food causes the feed to be adulterated and in violation of the Federal Food, Drug, and...

78 FR 10107 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

Science.gov (United States)

2013-02-13

... AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting. SUMMARY: The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110...

Household food insecurity and dietary intake among Mexican-American women participating in federal food assistance programs

Science.gov (United States)

This study explored the association between food insecurity and dietary intake among Mexican-American women after controlling for sociocultural and economic factors including participation in federal food assistance programs. A cross-sectional design was used. Demographics, anthropometrics, accultur...

Enhancing food safety: the role of the Food and Drug Administration

National Research Council Canada - National Science Library

Wallace, Robert B; Oria, Maria

2010-01-01

.... Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources...

Federal Procurement Standards Applied to School Food Services.

Science.gov (United States)

VanEgmond-Pannell, Dorothy

1984-01-01

Explains standards laid out in Federal Circular A-120 to ensure accountability, uniformity of standards, legal compliance, and efficiency in school food service procurement. Includes bidding and contract award procedures, contract compliance considerations, and cost-cutting methods. (MCG)

76 FR 53050 - New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene Disalicylate, Flunixin...

Science.gov (United States)

2011-08-25

... with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to improve the accuracy and... in 21 CFR Parts 520 and 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act...) * * * (c) [Reserved] (d) Conditions of use--(1) Dogs--(i) Amount. Administer 2 to 40 mg (up to 120 mg in...

78 FR 21613 - Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas...

Science.gov (United States)

2013-04-11

... Availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the selection of disease areas to... selection criteria, which were published in the September 24, 2012, Federal Register notice: Disease areas... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0967...

["Podmoskovie"--health resort institution of the Federal Drug Control Service of the Russian Federation celebrates the 20th anniversary].

Science.gov (United States)

Bondar', I V; Minaev, D Iu; Nasretdinov, I N; Petukhov, A E

2014-12-01

The article is dedicated to the 20th anniversary of the Federal government health resort institution of the Federal Drug Control Service of the Russian Federation (FGI "Health resort "Podmoskovie" of the Federal Drug Control Service of the Russian Federation). In this health resort were developed treatment programs for patients with abnormalities of the cardiovascular, respiratory and digestive systems; methods of ultrasonic, laser and magnetic therapy, atmospheric hypoxic, herbal medicine, speleotherapy are employed. Widely used natural healing factors of Ruza district of the Moscow region such as climate therapy, treatment with mineral water group of X type of Smolensk from own wells and balneo-mudtherapy. Over the past 20 years 70 000 patients received an appropriate treatment in this health resort.

Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration.

Science.gov (United States)

Oram, Matthew

2016-09-01

Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s. This has commonly been explained through the increase in prohibitive federal regulations during the 1960s that aimed to curb the growing recreational use of the drug. However, closely examining the Food and Drug Administration's regulation of LSD research in the 1960s will reveal that not only was LSD research never prohibited, but that the administration supported research to a greater degree than has been recognized. Instead, the decline in research reflected more complex changes in the regulation of pharmaceutical research and development. © The Author(s) 2016.

76 FR 34086 - Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information...

Science.gov (United States)

2011-06-10

... Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Oral Fluid Specimen for Drug Testing AGENCY: Substance Abuse and Mental... may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (oral fluid...

Food and Drug Labeling and the Adult Reader.

Science.gov (United States)

McKenna, Michael C.; Aker, Richard

1978-01-01

Full disclosure of ingredients on food, drugs, and cosmetic labels is really non-disclosure where the chemical formulation has no common name or where one generic name covers a variety of formations. The Food and Drug Administration offers suggestions for adult education programs in consumer awareness, understanding compound nomenclature, and…

Code of Federal Regulations Title 21

Data.gov (United States)

U.S. Department of Health & Human Services — This database contains the most recent revision from the Government Printing Office (GPO) of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs.

77 FR 71009 - Framework for Pharmacy Compounding: State and Federal Roles

Science.gov (United States)

2012-11-28

...] Framework for Pharmacy Compounding: State and Federal Roles AGENCY: Food and Drug Administration, HHS... Federal Roles.'' At this public meeting, FDA and State representatives will share their perspectives. Date... would require compliance with Federal standards. In addition, there are open questions about whether...

21 CFR 20.2 - Production of records by Food and Drug Administration employees.

Science.gov (United States)

2010-04-01

... upon an officer or employee of the Food and Drug Administration commanding the production of any record... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

Science.gov (United States)

2012-03-13

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program.'' This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre- dissemination review'' is used throughout the guidance to refer to review under the FD&C Act, which is entitled ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These proposed TV ads will be subject to a 45-calendar day review clock by FDA.

76 FR 72617 - Animal Drugs, Feeds, and Related Products; Eprinomectin; N-Methyl-2-Pyrrolidone

Science.gov (United States)

2011-11-25

... (NMP), is a carcinogen. As required by section 512(d)(1)(I) of the Federal Food, Drug, and Cosmetic Act... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 500, 522, and...-Pyrrolidone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug...

Drug-food interaction counseling programs in teaching hospitals.

Science.gov (United States)

Wix, A R; Doering, P L; Hatton, R C

1992-04-01

The results of a survey to characterize drug-food interaction counseling programs in teaching hospitals and solicit opinions on these programs from pharmacists and dietitians are reported. A questionnaire was mailed to the pharmacy director and the director of dietary services at teaching hospitals nationwide. The questionnaire contained 33 questions relating to hospital characteristics, drug-food interaction counseling programs, and the standard calling for such programs issued by the Joint Commission on Accreditation of Healthcare Organizations. Of 792 questionnaires mailed, 425 were returned (response rate, 53.7). A majority of the pharmacists and dietitians (51.2%) did not consider their drug-food interaction counseling program to be formal; some had no program. The pharmacy department was involved more in program development than in the daily operation of such programs. The most frequent methods of identifying patients for counseling were using lists of patients' drugs and using physicians' orders. A mean of only five drugs were targeted per program. Slightly over half the respondents rated the Joint Commission standard less effective than other standards in its ability to improve patient care. A majority of teaching hospitals did not have formal drug-food interaction counseling programs. Pharmacists and dietitians did not view these programs as greatly beneficial and did not believe that the Joint Commission has clearly delineated the requirements for meeting its standard.

28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco, Firearms, and Explosives, Bureau of Prisons, Federal... Administrative Matters § 0.138 Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of...

Analysis of possible food/nutrient and drug interactions in hospitalized patients

Directory of Open Access Journals (Sweden)

Everton Moraes Lopes

2010-09-01

Full Text Available Objective: To evaluate the prescription in relation to the possible interactions between drugs and foods/nutrients in the diets of patients in the Hospital Regional Justino Luz in the municipality of Picos, Piauí, Brazil. Methods: The sample consisted of 60 medical records of patients admitted at the hospital. The records were analyzed according to the presence or absence of interactions between drugs and foods/nutrients of the prescribed diets. Results: Of the 82 drugs prescribed in all periods, there were 16 drugs (19.5% with possible interaction with food, a total of 60 interactions between nutrient/food and medicine. Thus, 18 (30%, 10 (17% and 8 (13% possible interactions were identified with captopril (cardiovascular drug with acetylsalicylic acid (anti-inflammatory and spironolactone (diuretic, respectively representing the highest numbers of interactions among the classes of investigated drugs. It was also found that the total interactions between food/nutrients and drugs, 32 (53% accounted for interactions with cardiovascular drugs, 13 (22% with anti-inflammatory drugs, 11 (18% with diuretic agents e 4 (7% with drugs that act on the digestive tract. Conclusion: There was a high number of interactions between food/nutrients and medicines emphasizing the need for prior knowledge of these interactions as a way to avoid impairment in the treatment, longer hospital stays and/or damage to the nutritional status of the patients.

76 FR 64354 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

Science.gov (United States)

2011-10-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). In particular...

76 FR 45818 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

Science.gov (United States)

2011-08-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA...

75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

Science.gov (United States)

2010-03-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

Science.gov (United States)

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

Science.gov (United States)

2012-02-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

Pavlovian influences over food and drug intake.

Science.gov (United States)

Woods, S C; Ramsay, D S

2000-06-01

Consuming food and taking drugs share several important characteristics. In particular, each causes changes in important physiological parameters that are constantly being monitored and regulated by the brain. As examples, blood glucose increases after meals; and body temperature decreases after ethanol is taken. Such changes elicit neurally-mediated homeostatic responses that serve to reduce the magnitude and duration of the perturbation. It is argued that when an individual can accurately anticipate pending meals or drugs, it can make appropriate responses to minimize or totally neutralize the meal/drug-elicited perturbations. This phenomenon, which is the basis for meal and drug tolerance, relies upon Pavlovian conditioning. Literature is reviewed which documents the role of conditioning processes in the development of tolerance. The argument is made that conditioned responses enable individuals to derive necessary or desirable aspects of food and drugs while minimizing some of their negative effects. In a final section, drug tolerance is discussed as a natural consequence of evolution-derived, meal-related learning processes, with associated negative consequences.

Legal and Administrative Feasibility of a Federal Junk Food and Sugar-Sweetened Beverage Tax to Improve Diet.

Science.gov (United States)

Pomeranz, Jennifer L; Wilde, Parke; Huang, Yue; Micha, Renata; Mozaffarian, Dariush

2018-02-01

To evaluate legal and administrative feasibility of a federal "junk" food (including sugar-sweetened beverages [SSBs]) tax to improve diet. To assess food definitions and administration models, we systematically searched (1) PubMed (through May 15, 2017) for articles defining foods subject to taxes, and legal and legislative databases as well as online for (2) US federal, state, and tribal junk food tax bills and laws (January 1, 2012-February 28, 2017); SSB taxes (January 1, 2014-February 28, 2017); and international junk food tax laws (as of February 28, 2017); and (3) federal taxing mechanisms and administrative methods (as of February 28, 2017). Articles recommend taxing foods by product category, broad nutrient criteria, specific nutrients or calories, or a combination. US junk food tax bills (n = 6) and laws (n = 3), international junk food laws (n = 2), and US SSB taxes (n = 10) support taxing foods using category-based (n = 8), nutrient-based (n = 1), or combination (n = 12) approaches. Federal taxing mechanisms (particularly manufacturer excise taxes on alcohol) and administrative methods provide informative models. From legal and administrative perspectives, a federal junk food tax appears feasible based on product categories or combination category-plus-nutrient approaches, using a manufacturer excise tax, with additional support for sugar and graduated tax strategies.

21 CFR 20.3 - Certification and authentication of Food and Drug Administration records.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Certification and authentication of Food and Drug... authentication of Food and Drug Administration records. (a) Upon request, the Food and Drug Administration will... or for authentication of records shall be sent in writing to the Freedom of Information Staff (HFI-35...

21 CFR 181.22 - Certain substances employed in the manufacture of food-packaging materials.

Science.gov (United States)

2010-04-01

... food-packaging materials. 181.22 Section 181.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... of food-packaging materials. Prior to the enactment of the food additives amendment to the Federal... manufacturing practice for food-packaging materials includes the restriction that the quantity of any of these...

75 FR 22412 - Food and Drug Administration/Xavier University Global Outsourcing Conference

Science.gov (United States)

2010-04-28

... Selection Process--the criteria a contract organization should use to consider saying no to a contract... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Outsourcing Conference AGENCY: Food and Drug...

Food and Drug Administration Drug Approval Process: A History and Overview.

Science.gov (United States)

Williams, Christopher Ty

2016-03-01

In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. Copyright © 2016 Elsevier Inc. All rights reserved.

The use of drugs in food animals: benefits and risks

National Research Council Canada - National Science Library

...; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industries--poultry, dairy, beef, swine, and aquaculture...

[Food-drug interactions: an underestimated risk].

Science.gov (United States)

Sönnichsen, A C; Donner-Banzhoff, N; Baum, E

2005-11-03

With only few exceptions, administration of medicaments should, in principle, be independent of food intake (at least half an hour before or two hours after eating). This ensures uniform and assessable bioavailability. However, it also entails the risk that the patient is more likely to forget to take medication postponed to 2 hours after a meal, than when it is directly coupled to a meal. Certain foodstuffs or food constituents, such as, for example, grapefruit, Seville orange juice, red wine, alcoholic drinks in general, or large quantities of caffeine and garlic should be avoided during drug treatment. In addition, specific interactions with certain drugs must also be taken into account (e.g. MAO inhibitors and tyramine, curamine and vitamin K).

75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

Science.gov (United States)

2010-04-22

...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Science.gov (United States)

2010-04-01

... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is...

Radiopharmaceutical regulation and Food and Drug Administration policy.

Science.gov (United States)

Rotman, M; Laven, D; Levine, G

1996-04-01

The regulatory policy of the Food and Drug Administration (FDA) on radiopharmaceuticals flows from a rigid, traditional, drug-like interpretation of the FDC Act on the licensing of radiopharmaceuticals. This contributes to significant delays in the drug-approval process for radiopharmaceuticals, which are very costly to the nuclear medicine community and the American public. It seems that radiopharmaceuticals would be better characterized as molecular devices. Good generic rule-making principles include: use of a risk/benefit/cost analysis; intent based on sound science; performance standards prepared by outside experts; a definite need shown by the regulatory agency; to live with the consequences of any erroneous cost estimates; and design individual credential requirements so that additional training results in enhanced professional responsibility. When these common elements are applied to current FDA policy, it seems that the agency is out of sync with the stated goals for revitalizing federal regulatory policies as deemed necessary by the Clinton administration. Recent FDA rulings on positron-emission tomography, Patient Package inserts, and on medical device service accentuate the degree of such asynchronization. Radiopharmaceutical review and licensing flexibility could be dramatically improved by excluding radiopharmaceuticals from the drug category and reviewing them as separate entities. This new category would take into account their excellent record of safety and their lack of pharmacological action. Additionally, their evaluation of efficacy should be based on their ability to provide useful scintiphotos, data, or responses of the physiological system it portends to image, quantitate, or describe. To accomplish the goal of transforming the FDA's rigid, prescriptive policy into a streamlined flexible performance-based policy, the Council on Radionuclides and Radiopharmaceuticals proposal has been presented. In addition, it is suggested that the United

Food labeling; nutrition labeling of standard menu items in restaurants and similar retail food establishments. Final rule.

Science.gov (United States)

2014-12-01

To implement the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we) is requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The ACA, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the ACA, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to these Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.

Quantifying The Food And Drug Administration's rulemaking delays highlights the need for transparency.

Science.gov (United States)

Hwang, Thomas J; Avorn, Jerry; Carpenter, Daniel; Kesselheim, Aaron S

2014-02-01

The Food and Drug Administration (FDA) frequently uses its rulemaking process to establish or modify the way it regulates drugs, medical devices, and other medical products. The federal agency's rulemaking is controversial because of its perceived complexity, lack of transparency, and lengthy duration. To shed light on the FDA's rulemaking process, we examined the evolution of significant rules that the agency published during 2000-12 for drugs, devices, and other medical products. We found that the rules' median time to finalization was 7.3 years, with the pre-rule phase and postreview deliberation within the FDA accounting for the majority of that time. Rules that involved mandatory cost-benefit analyses were associated with an additional delay of approximately two years. We also found that longer review times were significantly associated with a reduction in the stringency of final rules, compared to the originally proposed versions. We recommend improving FDA's rulemaking by allocating additional resources to increase efficiency and by embarking on initiatives to promote transparency by the FDA and other parts of the executive branch.

The impact of the Food and Drug Administration Modernization Act on the recruitment of children for research.

Science.gov (United States)

Sharav, Vera Hassner

2003-01-01

This article argues that contrary to the claims made by research stakeholders in industry, academia and government, the shift in public policy since the enactment of the Food and Drug Administration Modernization Act (FDAMA) of 1997 and its financial incentives to industry to test drugs on children, has had a deleterious impact on children's dignity, health and welfare. Those lucrative incentives offered an opportunity to accelerate the pace of FDA approval for pediatric drug marketing. FDAMA resulted in a radical shift in federal policy to accommodate an expansion of pediatric trials. Children who are precluded from exercising a human adult's right to informed consent to research are increasingly sought as test subjects even when the trials offer no potential benefit for them. Prior to FDAMA children were protected under federal regulations that prohibited their recruitment for experiments that were not in their best interest. This article discusses eight cases and controversies demonstrating that children have been subjected to experiments that exposed them to pain, discomfort, and serious risks of harm. Babies have died testing a lethal heartburn drug; children have been subjected to "forced dose titration" in antidepressant drug trials that resulted in several suicide attempts. Toddlers are currently being subjected to methylphenidate dose tolerance tests without evidence of any pathological condition. Healthy teenagers are being exposed to antipsychotic drugs known to induce severe pathological side effects in speculative "schizophrenia prevention" experiments.

Assessment of socioeconomic consequences of drug abuse in the Ural federal district

Directory of Open Access Journals (Sweden)

Inessa Aleksandrovna Gurban

2013-06-01

Full Text Available The paper considers issues of the assessment of the socioeconomic consequences of drug abuse in today’s conditions, which have the following features — the approaching of drug-dealers to legalize the drug market, develop the illegal drug market and their analogs and derivatives by the introduction of modern production technologies and distribution of psychoactive agents. Key tendencies observed in the contemporary world in the field of dynamics of the drug market development, which are reflected in the regions of Russia including the Ural Federal District are revealed. The procedure of assessment of socioeconomic expenses of drug abuse including assessment of drug consumers’ expenses and their surrounding people; and also; maintenance costs of the state bodies supervising drug trafficking; expenses for health care and other social expenses connected to drug use; damage to individuals of drug abuse distribution; expenses of private institutions and establishments; socioeconomic impact of drug abuse distribution. The technique uses a tool allowing to carry out a calculation (a heroin equivalent, i.e. the drugs withdrawn by law enforcement agencies and the subsequent calculation of the corresponding number of consumers of each type of drug. This method is aimed at increasing the accuracy of estimates received. On the basis of results calculated according to offered technique, the shares of socioeconomic expenses of drug abuse concerning the income of the cumulative consolidated budget and a gross regional product of the Ural Federal District are defined.

78 FR 21058 - New Animal Drugs; Change of Sponsor

Science.gov (United States)

2013-04-09

...-803 TASK (dichlovos) Dog Anthelmintic. 35-918 EQUIGARD (dichlovos). 38-200 MEDAMYCIN (oxytetracycline..., under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food...

77 FR 23485 - Food and Drug Administration Patient Network Annual Meeting; Input Into Food and Drug...

Science.gov (United States)

2012-04-19

...: Notice. The Food and Drug Administration (FDA) is announcing a meeting for patients, caregivers..., caregivers, independent patient advocates, and patient advocate groups that seek to: Educate and inform... of patients? (2) What methodological and practical issues should FDA consider as it develops its...

Federal Strategy for Prevention of Drug Abuse and Drug Trafficking, 1982. Prepared for the President Pursuant to the Drug Abuse Office and Treatment Act of 1972.

Science.gov (United States)

Office of Policy Development, Washington, DC.

This document describes the Federal response to drug abuse and drug trafficking. The actions of President Reagan, in Executive Order 12368, establishing an official advisor on drug abuse policy matters, and the priorities, issues, and objectives (international cooperation, drug law enforcement, education and prevention, detoxification and…

Nuclear methods for food analysis at the U.S. Food and Drug Administration

International Nuclear Information System (INIS)

Anderson, D.L.; Cunningham, W.C.; Capar, S.G.; Baratta, E.J.; Mackill, P.

2001-01-01

An overview radioanalytical techniques used in support of research, monitoring programs, and field assignments directed by the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) is presented. The Winchester Engineering and Analytical Center annually determines radionuclide concentrations in 260 Total Diet Study foods, approximately 80 imported foods, and a selection of domestic foods collected near U.S. nuclear power plants. Radioanalytical techniques used at CFSAN's neutron analysis laboratory at the National Institute of Standards and Technology are discussed along with applications for research, quality control, and special projects. (author)

76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

Science.gov (United States)

2011-09-09

...] Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug... conference for representatives of Health Professional Organizations. Dr. Margaret Hamburg, Commissioner of... person attending, the name of the organization, address, and telephone number. There is no registration...

Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug

Science.gov (United States)

... Cancer Currents Blog Cancer Currents Blog Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug Subscribe April ... to this page included, e.g., “Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug was originally ...

75 FR 45632 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2011

Science.gov (United States)

2010-08-03

...), beginning with the letters AD, from the upper right-hand corner of your completed Animal Drug User Fee Cover...] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2011 AGENCY: Food and Drug... payment procedures for fiscal year (FY) 2011 animal drug user fees. The Federal Food, Drug, and Cosmetic...

75 FR 32483 - Prescription Drug User Fee Act; Meetings on Reauthorization; Request for Notification of...

Science.gov (United States)

2010-06-08

.../Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0128] Prescription Drug User Fee Act; Meetings on Reauthorization; Request for Notification of Stakeholder Intention...

Is the clinical relevance of drug-food and drug-herb interactions limited to grapefruit juice and Saint-John's Wort?

Science.gov (United States)

Mouly, Stéphane; Lloret-Linares, Célia; Sellier, Pierre-Olivier; Sene, Damien; Bergmann, J-F

2017-04-01

An interaction of drug with food, herbs, and dietary supplements is usually the consequence of a physical, chemical or physiologic relationship between a drug and a product consumed as food, nutritional supplement or over-the-counter medicinal plant. The current educational review aims at reminding to the prescribing physicians that the most clinically relevant drug-food interactions may not be strictly limited to those with grapefruit juice and with the Saint John's Wort herbal extract and may be responsible for changes in drug plasma concentrations, which in turn decrease efficacy or led to sometimes life-threatening toxicity. Common situations handled in clinical practice such as aging, concomitant medications, transplant recipients, patients with cancer, malnutrition, HIV infection and those receiving enteral or parenteral feeding may be at increased risk of drug-food or drug-herb interactions. Medications with narrow therapeutic index or potential life-threatening toxicity, e.g., the non-steroidal anti-inflammatory drugs, opioid analgesics, cardiovascular medications, warfarin, anticancer drugs and immunosuppressants may be at risk of significant drug-food interactions to occur. Despite the fact that considerable effort has been achieved to increase patient' and doctor's information and ability to anticipate their occurrence and consequences in clinical practice, a thorough and detailed health history and dietary recall are essential for identifying potential problems in order to optimize patient prescriptions and drug dosing on an individual basis as well as to increase the treatment risk/benefit ratio. Copyright © 2016 Elsevier Ltd. All rights reserved.

77 FR 45629 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

Science.gov (United States)

2012-08-01

..., beginning with the letters ``AG'', from the upper right-hand corner of your completed Animal Generic Drug...] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013 AGENCY: Food and Drug... payment procedures for fiscal year (FY) 2013 generic new animal drug user fees. The Federal Food, Drug...

75 FR 1021 - Certain Other Dosage Form New Animal Drugs; Sevoflurane

Science.gov (United States)

2010-01-08

... Halocarbon Products Corp. The ANADA provides for the use of sevoflurane inhalant anesthetic in dogs. DATES... anesthetic, in dogs. Halocarbon Products Corp.'s Sevoflurane is approved as a generic copy of SEVOFLO... Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs...

Federalizing Medical Campaigns against Alcoholism and Drug Abuse

Science.gov (United States)

Metlay, Grischa

2013-01-01

Context The formation of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Special Action Office for Drug Abuse Prevention (SAODAP) in the early 1970s dramatically expanded scientific and medical efforts to control alcoholism and drug abuse in the United States. Methods Drawing on a variety of primary, secondary, and archival sources, this article describes the creation and early years of these agencies. Findings I show that while the agencies appeared at roughly the same time, their creation involved separate sets of issues and actors. In addition, I show that SAODAP received more money and resources, even though advocates for alcoholics mobilized a stronger lobbying campaign. Conclusions Two factors explain this discrepancy in money and resources: (1) alcoholism was framed as a public health problem, whereas drug abuse was drawn into broader debates about crime and social decline; and (2) alcohol programs relied on congressional support, whereas drug programs found champions at high levels of the Nixon administration. These political and cultural factors help explain why current programs for illegal drugs receive more federal support, despite alcohol's greater public health burden. PMID:23488713

Federalizing medical campaigns against alcoholism and drug abuse.

Science.gov (United States)

Metlay, Grischa

2013-03-01

The formation of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Special Action Office for Drug Abuse Prevention (SAODAP) in the early 1970s dramatically expanded scientific and medical efforts to control alcoholism and drug abuse in the United States. Drawing on a variety of primary, secondary, and archival sources, this article describes the creation and early years of these agencies. I show that while the agencies appeared at roughly the same time, their creation involved separate sets of issues and actors. In addition, I show that SAODAP received more money and resources, even though advocates for alcoholics mobilized a stronger lobbying campaign. Two factors explain this discrepancy in money and resources: (1) alcoholism was framed as a public health problem, whereas drug abuse was drawn into broader debates about crime and social decline; and (2) alcohol programs relied on congressional support, whereas drug programs found champions at high levels of the Nixon administration. These political and cultural factors help explain why current programs for illegal drugs receive more federal support, despite alcohol's greater public health burden. © 2013 Milbank Memorial Fund.

[Chemical pollution of baby food products in the Russian Federation].

Science.gov (United States)

Pivovarov, Yu P; Milushkina, O Yu; Tikhonova, y l; Aksenova, O I; Kalinovskaya, M V

One of the main problems of nutrition of children and adolescents is to assess chemical contamination of baby food products and the establishment of the relation with the health of the child population. With the entering different chemical compounds in the body of the child there can be observed disorders of the nervous, urinary, cardiovascular system, gastrointestinal tract, as well as metabolic deteriorations, degenerative processes in parenchymal organs and bone destruction. The aim of the study was to analyze data on chemical contamination of baby food products in the Russian Federation for 2012-2014. The analysis was executed on the data of Federal Information Fund of social and hygienic monitoring of the Russian Federation. There were identified priority pollutants (toxic elements, nitrites, nitrates, nitrosamines, pesticides, hydroxymethylfurfural, mycotoxins) and risk areas (the Lipetsk region, the Krasnodar Territory, the Republic of Adygea, city of Moscow, Tatarstan, the Kabardino-Balkar Republic, the Ryazan region). There are detected contamination levels not exceeding MAC (in the dynamics of the three years offollow up, on average 22%), requiring their hygienic assessment. There were determined the baby food products containing most common occurred chemical contaminants: fruits and vegetables products, canned products, canned meat, cereals, dairy products, liquid and adapted and partially adapted milk formalas. Identified data indicate to a need for further studies of chemical substances in products for children’s nutrition in order to establish the causal relationships with a various diseases and the substantiation of methodological approaches to the risk assessment of combined exposure to chemical contaminants in concentrations up to the MPC on health of children, including infants.

21 CFR 2.110 - Definition of ammonia under Federal Caustic Poison Act.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Definition of ammonia under Federal Caustic Poison... SERVICES GENERAL GENERAL ADMINISTRATIVE RULINGS AND DECISIONS Caustic Poisons § 2.110 Definition of ammonia under Federal Caustic Poison Act. For the purpose of determining whether an article containing ammonia...

27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

Science.gov (United States)

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Compliance with Food and Drug Administration requirements. 17.136 Section 17.136 Alcohol, Tobacco Products and Firearms ALCOHOL... Compliance with Food and Drug Administration requirements. A product is not a medicine, medicinal preparation...

76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

Science.gov (United States)

2011-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

Science.gov (United States)

2013-03-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0168] Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Food Cravings, Appetite, and Snack-Food Consumption in Response to a Psychomotor Stimulant Drug: The Moderating Effect of ‘Food Addiction’

Directory of Open Access Journals (Sweden)

Caroline eDavis

2014-05-01

Full Text Available There is mounting evidence that many highly processed foods have addictive properties, and that some cases of compulsive overeating are behavioral addictions. While support for the Yale Food Addiction Scale (YFAS as a valid diagnostic tool has been impressive and continues to increase, to date, no research has examined the food-addiction construct in response to an actual food stimulus, and in relation to direct measures of appetite and food consumption. As part of a larger community-based study of overeating in healthy adults who were predominately overweight and obese (aged 25-50 years, 136 participants completed the YFAS, of whom 23 met the diagnostic criteria for food addiction. They took part in a 2-day, double-blind, cross-over, single-dose drug challenge using a psychomotor stimulant (methylphenidate and placebo. Participants were first assessed on ratings of appetite and food cravings after holding and tasting their favorite snack food, after which they were able to eat all or part of the snack, as they wished. Three separate repeated-measures Analysis of Variance (ANOVA procedures were carried out, each with 2 between-subjects factors (Diagnosis: food addiction vs non-food addiction and (Sex: male vs female and 1 within-subjects factor (Days: drug vs placebo. As anticipated, for all three dependent variables, there was a significant main effect for Days with a response decrease from placebo to the drug condition. With respect to food cravings and appetite ratings, results indicated that the food-addiction group had significantly higher scores on both variables (p<0.0001. For food consumption, there was a significant Days x Diagnosis interaction (p=0.018 whereby the food-addiction group showed no food-intake suppression across days compared to the non-food-addiction group who demonstrated a significant decrease in snack-food consumption with methylphenidate. The finding that the food-addiction group was resistant to the food

78 FR 46955 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

Science.gov (United States)

2013-08-02

... courier such as Federal Express or United Parcel Service, the courier may deliver the check and printed... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0007] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014 AGENCY: Food and Drug...

Technology assessment and the Food and Drug Administration

Science.gov (United States)

Kaplan, A. H.; Becker, R. H.

1972-01-01

The statutory standards underlying the activities of the FDA, and the problems the Agency faces in decision making are discussed from a legal point of view. The premarketing clearance of new drugs and of food additives, the two most publicized and criticized areas of FDA activity, are used as illustrations. The importance of statutory standards in technology assessment in a regulatory setting is developed. The difficulties inherent in the formulation of meaningful standards are recognized. For foods, the words of the statute are inadequate, and for drugs, a statutory recognition of the various other objectives would be useful to the regulator and the regulated.

78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

Science.gov (United States)

2013-05-22

... 24, 2013, from approximately 1 p.m. to 3:45 p.m. Location: Food and Drug Administration, White Oak..., Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, White Oak Bldg... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

76 FR 61366 - Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to...

Science.gov (United States)

2011-10-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase...: Food and Drug Administration, HHS. [[Page 61367

Analysis of possible food/nutrient and drug interactions in hospitalized patients

OpenAIRE

Lopes, Everton Moraes; Carvalho, Rumão Batista Nunes de; Freitas, Rivelilson Mendes de

2010-01-01

ABSTRACT Objective: To evaluate the prescription in relation to the possible interactions between drugs and foods/nutrients in the diets of patients in the Hospital Regional Justino Luz in the municipality of Picos, Piauí, Brazil. Methods: The sample consisted of 60 medical records of patients admitted at the hospital. The records were analyzed according to the presence or absence of interactions between drugs and foods/nutrients of the prescribed diets. Results: Of the 82 drugs prescribed...

Study design for a clinical trial to examine food price elasticity among participants in federal food assistance programs: A laboratory-based grocery store study

Directory of Open Access Journals (Sweden)

Zach Conrad

2018-06-01

Full Text Available We present a protocol for a study investigating the effect of food price changes on purchasing decisions among individuals participating in federal food assistance programs and among those not participating in these programs. We use a laboratory-based grocery store design, which provides greater control over factors influencing food purchasing than in situ experiments in actual grocery stores. We focus primarily, but not exclusively, on eggs because they are highly nutritious, easy to prepare, can be included in many different dishes, and are a part of a wide range of cultural food menus. The primary aim of this study is to compare the own-and cross-price elasticity of eggs between individuals participating in federal food assistance programs and those not participating in these programs. Our secondary aims are to 1 compare the own- and cross-price elasticity of eggs between overweight/obese individuals and non-overweight/obese individuals, 2 examine whether delay discounting moderates the effect of income on own- and cross-price elasticity, 3 examine whether subjective social status moderates the effect of participation in federal food assistance programs on the purchase of high nutrient-dense foods, and 4 examine whether usual psychological stress level moderates the effect of subjective social status on the purchase of high-nutrient dense foods. The results of this study will provide information about the drivers of food demand among low-income adults. A better understanding of these drivers is needed to develop effective nutrition interventions for this large population. Keywords: Price elasticity, Food assistance, Egg, Obesity, Social status, Stress

75 FR 54492 - Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic...

Science.gov (United States)

2010-09-08

... Ophthalmic Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment... acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and... GENTOCIN DURAFILM (gentamicin sulfate and betamethasone acetate) Ophthalmic Solution, sponsored by Intervet...

77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

Science.gov (United States)

2012-02-27

... Oversight of PET Drug Products--Questions and Answers.'' The draft guidance provides questions and answers... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic... PET Drug Products--Questions and Answers.'' In 1997, Congress passed the Food and Drug Administration...

The Family and Federal Drug Abuse Policies--Programs: Toward Making the Invisible Family Visible.

Science.gov (United States)

Clayton, Richard R.

1979-01-01

Notes why the family is not considered in drug policy and programing and asserts that existing conditions demand conscious consideration of the family in efforts of federal drug agencies. Data show changing parameters of drug use-abuse. A research and prevention agenda that integrates the family is presented. (Author/BEF)

78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

Science.gov (United States)

2013-03-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

76 FR 28046 - Memorandum of Understanding Between the Food and Drug Administration and the International...

Science.gov (United States)

2011-05-13

... Tots Public-Private Partnership AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0005; FDA 225-09-0014] Memorandum of Understanding Between the Food and Drug Administration and the...

78 FR 20666 - Food and Drug Administration/National Institutes of Health/National Science Foundation Public...

Science.gov (United States)

2013-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0345] Food and Drug Administration/National Institutes of Health/ National Science Foundation Public Workshop... public workshop; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing its...

76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

Science.gov (United States)

2011-11-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

Science.gov (United States)

2010-09-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0367] Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-07-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

Alignment of Children's Food Advertising With Proposed Federal Guidelines.

Science.gov (United States)

Hingle, Melanie D; Castonguay, Jessica S; Ambuel, Danielle A; Smith, Rachel M; Kunkel, Dale

2015-06-01

It is well established that children are exposed to food marketing promoting calorically dense, low-nutrient products. Reducing exposure to obesogenic marketing presents an opportunity to improve children's health. The purpose of this study was to determine the extent to which televised food advertising practices targeting children (aged ≤12 years) were consistent with guidelines proposed by a coalition of federal authorities known as the Interagency Working Group on Foods Marketed to Children (IWG). A sample of children's TV programming aired on five national broadcast networks and two cable channels (N=103 shows) was recorded February to April 2013. The sample contained 354 food ads. Advertised products were identified and categorized using industry classification codes and nutrient data obtained from manufacturers. Product compliance with IWG saturated fat, trans fat, added sugar, and sodium guidelines was evaluated. Analyses conducted in 2013 revealed that nearly all food ads (94%) met guidelines for trans fats; 68% and 62% met guidelines for sodium and saturated fat, respectively; and 20% complied with added sugar guidelines. Overall, 1.4% of all child-targeted food ads met all aspects of IWG guidelines. Nearly all food advertisements exceeded guidelines for at least one recommended nutrient to limit. Individually, conformity was high for guidelines for trans fats, moderate for sodium and saturated fats, and poor for added sugar. These findings suggest that child-targeted food advertising remains strongly biased toward less healthy options. Policymakers wishing to regulate food marketing should understand the amount and types of advertisements that children view. Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Barriers to Sustainable Food Trade: China’s Exports Food Rejected by the U.S. Food and Drug Administration 2011–2017

Directory of Open Access Journals (Sweden)

Xiaowei Wen

2018-05-01

Full Text Available Food export rejection can be a harmful barrier to sustainable international food trade. To understand China’s export food rejected by FDA (Food and Drug Administration of the United States, we analyzed 4047 cases of rejection from February 2011 to July 2017. Although the number of rejected food exported from China to the United States has been declining, and the quality has been improving, there is still space for improvement. Of the 4047 cases of rejection, the Guangdong, Fujian and Shandong provinces were the top three with the largest number of rejected food (1253 (31%, 520 (12.8%, and 508 (12.6%, respectively (being rejected mainly in New York and Los Angeles. The top four types of rejected food involved fruits and vegetables, fishery and seafood products, bakery products, grain and related processed products. More importantly, the major reasons for rejection can be attributed to problems in maintaining food safety, namely: (1 the food contained filth, decay, decomposition or other substances; (2, the food contained toxic and harmful substances (e.g., suspected melamine, chemical insecticides, or lead; and (3 the food contained agricultural and veterinary drugs. The results are of great implications for the United States to regulate the imported food from China, and for China to improve the quality and safety of export food.

78 FR 277 - Food and Drug Administration Actions Related to Nicotine Replacement Therapies and Smoking...

Science.gov (United States)

2013-01-03

... Dependence; Public Hearing; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; Extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No...

75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2010-11-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

Science.gov (United States)

2011-02-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

Analysis of U.S. Food and Drug Administration food allergen recalls after implementation of the food allergen labeling and consumer protection act.

Science.gov (United States)

Gendel, Steven M; Zhu, Jianmei

2013-11-01

To avoid potentially life-threatening reactions, food allergic consumers rely on information on food labels to help them avoid exposure to a food or ingredient that could trigger a reaction. To help consumers in the United States obtain the information that they need, the Food Allergen Labeling and Consumer Protection Act of 2004 defined a major food allergen as being one of eight foods or food groups and any ingredient that contains protein from one of these foods or food groups. A food that contains an undeclared major food allergen is misbranded under the U.S. Food, Drug, and Cosmetic Act and is subject to recall. Food allergen labeling problems are the most common cause of recalls for U.S. Food and Drug Administration (FDA)-regulated food products. To help understand why food allergen recalls continue to occur at a high rate, information on each food allergen recall that occurred in fiscal years 2007 through 2012 was obtained from the FDA recall database. This information was analyzed to identify the food, allergen, root cause, and mode of discovery for each food allergen recall. Bakery products were the most frequently recalled food type, and milk was the most frequently undeclared major food allergen. Use of the wrong package or label was the most frequent problem leading to food allergen recalls. These data are the first reported that indicate the importance of label and package controls as public health measures.

76 FR 12135 - Publication Procedures for Federal Register Documents During a Funding Hiatus

Science.gov (United States)

2011-03-04

... Public Law 101-508, 104 Stat. 1388 (31 U.S.C. 1341), the Office of the Federal Register (OFR) announces... more Federal agencies, the OFR will remain open to accept and process documents authorized to be... as those related to the constitutional duties of the President, food and drug inspection, air traffic...

The dopamine motive system: implications for drug and food addiction.

Science.gov (United States)

Volkow, Nora D; Wise, Roy A; Baler, Ruben

2017-11-16

Behaviours such as eating, copulating, defending oneself or taking addictive drugs begin with a motivation to initiate the behaviour. Both this motivational drive and the behaviours that follow are influenced by past and present experience with the reinforcing stimuli (such as drugs or energy-rich foods) that increase the likelihood and/or strength of the behavioural response (such as drug taking or overeating). At a cellular and circuit level, motivational drive is dependent on the concentration of extrasynaptic dopamine present in specific brain areas such as the striatum. Cues that predict a reinforcing stimulus also modulate extrasynaptic dopamine concentrations, energizing motivation. Repeated administration of the reinforcer (drugs, energy-rich foods) generates conditioned associations between the reinforcer and the predicting cues, which is accompanied by downregulated dopaminergic response to other incentives and downregulated capacity for top-down self-regulation, facilitating the emergence of impulsive and compulsive responses to food or drug cues. Thus, dopamine contributes to addiction and obesity through its differentiated roles in reinforcement, motivation and self-regulation, referred to here as the 'dopamine motive system', which, if compromised, can result in increased, habitual and inflexible responding. Thus, interventions to rebalance the dopamine motive system might have therapeutic potential for obesity and addiction.

Food irradiation: contaminating our food

International Nuclear Information System (INIS)

Piccioni, R.

1988-01-01

The nuclear industry has promoted food irradiation as an effective and safe means of preserving food at minimum risk to the public. However, wide-scale food irradiation programmes such as that approved in the United States of America would have an adverse impact on public health in the following ways: through the consumption of carcinogenic substances generated in irradiated foods, through the use of irradiation to mask bacteriological contamination of spoiled food, through the replacement of fresh foods with nutritionally depleted foods, through accidents with leaks or mishandling of the radiation sources used and through the environmental damage resulting from reactor operation or spent fuel reprocessing necessary to produce the required isotopes for food irradiation. The food irradiation market is potentially enormous, requiring a large number of facilities and isotopes, some, such as caesium-137, would come from the production of nuclear weapons. Evidence of the presence of carcinogenic or mutagenic activity in irradiated foods is discussed. Although the US Federal Drug Administration (FDA) has approved a food irradiation programme it would actually be against the FDA's legal obligation which is to protect the health and safety of the American people. (UK)

The drive to eat: comparisons and distinctions between mechanisms of food reward and drug addiction.

Science.gov (United States)

DiLeone, Ralph J; Taylor, Jane R; Picciotto, Marina R

2012-10-01

The growing rates of obesity have prompted comparisons between the uncontrolled intake of food and drugs; however, an evaluation of the equivalence of food- and drug-related behaviors requires a thorough understanding of the underlying neural circuits driving each behavior. Although it has been attractive to borrow neurobiological concepts from addiction to explore compulsive food seeking, a more integrated model is needed to understand how food and drugs differ in their ability to drive behavior. In this Review, we will examine the commonalities and differences in the systems-level and behavioral responses to food and to drugs of abuse, with the goal of identifying areas of research that would address gaps in our understanding and ultimately identify new treatments for obesity or drug addiction.

Brazilian Federal Police drug chemical profiling - the PeQui project.

Science.gov (United States)

Zacca, Jorge J; Botelho, Elvio Dias; Vieira, Maurício L; Almeida, Fernanda L A; Ferreira, Luciana S; Maldaner, Adriano O

2014-07-01

Over the past six years the Brazilian Federal Police has undertaken major efforts in order to implement and to develop its own drug chemical profiling program. This paper aims to provide a broad perspective regarding the managerial strategies and some examples of subsequent technical issues involved in the implementation of such a project. Close collaboration with local drug enforcement and investigation teams, establishment of proper worldwide partnerships with well recognized institutions in the field of drug analysis and the attainment of suitable funding and human resources are shown to be key success factors. Some preliminary results concerning the chemical profile of cocaine seizures in Brazil during this process are presented. Copyright © 2014 Forensic Science Society. Published by Elsevier Ireland Ltd. All rights reserved.

21 CFR 530.20 - Conditions for permitted extralabel animal and human drug use in food-producing animals.

Science.gov (United States)

2010-04-01

... consumption: (1) Such use must be accomplished in accordance with an appropriate medical rationale; and (2) If... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Conditions for permitted extralabel animal and human drug use in food-producing animals. 530.20 Section 530.20 Food and Drugs FOOD AND DRUG...

78 FR 59974 - Publication Procedures for Federal Register Documents During a Funding Hiatus

Science.gov (United States)

2013-09-30

... Public Law 101-508, 104 Stat. 1388 (31 U.S.C. 1341), the Office of the Federal Register (OFR) announces... hiatus affecting one or more Federal agencies, the OFR will remain open to accept and process documents... activities such as those related to the constitutional duties of the President, food and drug inspection, air...

78 FR 4153 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling...

Science.gov (United States)

2013-01-18

...] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling... label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the FD&C... other forms of information technology. Food Labeling; Notification Procedures for Statements on Dietary...

75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

Science.gov (United States)

2010-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

Science.gov (United States)

2011-01-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

Science.gov (United States)

2011-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

Science.gov (United States)

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

Science.gov (United States)

2010-07-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...

78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

Science.gov (United States)

2013-02-19

...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-06-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

Science.gov (United States)

2013-11-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

Science.gov (United States)

2012-04-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0094] Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

Science.gov (United States)

2011-12-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

Science.gov (United States)

2010-11-29

...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...

75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

Science.gov (United States)

2010-06-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS...

76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

Science.gov (United States)

2011-10-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

Science.gov (United States)

2011-11-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...

77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

Science.gov (United States)

2012-12-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

Science.gov (United States)

2013-01-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

Science.gov (United States)

2012-11-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals... Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The guidance provides guidance to industry for...

[Role of food interaction pharmacokinetic studies in drug development. Food interaction studies of theophylline and nifedipine retard and buspirone tablets].

Science.gov (United States)

Drabant, S; Klebovich, I; Gachályi, B; Renczes, G; Farsang, C

1998-09-01

Due to several mechanism, meals may modify the pharmacokinetics of drug products, thereby eliciting to clinically significant food interaction. Food interactions with the drug substance and with the drug formulation should be distinguished. Food interaction of different drug products containing the same active ingredient can be various depending on the pharmaceutical formulation technology. Particularly, in the case of modified release products, the food/formulation interaction can play an important role in the development of food interaction. Well known example, that bioavailability of theophylline can be influenced in different way (either increased, decreased or unchanged) by concomitant intake of food in the case of different sustained release products. The role and methods of food interaction studies in the different kinds of drug development (new chemical entity, modified release products, generics) are reviewed. Prediction of food effect response on the basis of the physicochemical and pharmacokinetic characteristics of the drug molecule or formulations is discussed. The results of three food interaction studies carried out the products of EGIS Pharmaceuticals Ltd. are also reviewed. The pharmacokinetic parameters of theophyllin 400 mg retard tablet were practically the same in both fasting condition and administration after consumption of a high fat containing standard breakfast. The ingestion of a high fat containing breakfast, increased the AUC of nifedipine from 259.0 +/- 101.2 ng h/ml to 326.7 +/- 122.5 ng h/ml and Cmax from 34.5 +/- 15.9 ng/ml to 74.3 +/- 23.9 ng/ml in case of nifedipine 20 mg retard tablet, in agreement with the data of literature. The statistical evaluation indicated significant differences between the pharmacokinetic parameters in the case of two administrations (before and after meal). The effect of a high fat containing breakfast for a generic version of buspiron 10 mg tablet and the bioequivalence after food consumption were

78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

Science.gov (United States)

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Drug Treatment within the U.S. Federal Prison System: Are Treatment Needs Being Met?

Science.gov (United States)

van Wormer, Katherine; Persson, Lance Edwards

2010-01-01

A large percentage of inmates in the U.S. federal prison system have serious drug problems and are in need of treatment before they return to society. Accordingly, the Federal Bureau of Prisons has revamped substance abuse programming consistent with the latest research and expanded treatment services throughout its institutions. This article…

78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

Science.gov (United States)

2013-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2013-N-0365] Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act AGENCY: Food and Drug Administration, HHS. ACTION: Establishment of...

77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

Science.gov (United States)

2012-08-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date; reopening of administrative record. Food and Drug Administration, HHS. Final rule; delay of effective date; reopening of administrative record.

Science.gov (United States)

2000-05-03

The Food and Drug Administration (FDA) is delaying until October 1, 2001, the effective date and reopening the administrative record to receive additional comments regarding certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). The other provisions of the final rule become effective on December 4, 2000. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). FDA is delaying the effective date for certain requirements relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record. FDA is also delaying the effective date of another requirement that would prohibit blood centers functioning as "health care entities" to act as wholesale distributors of blood derivatives. The agency is taking this action to address numerous concerns about the provisions raised by affected parties.

"It Goes on Everywhere": Injection Drug Use in Canadian Federal Prisons.

Science.gov (United States)

van der Meulen, Emily

2017-06-07

International and Canadian research on in-prison injection drug use has documented the frequency of its occurrence as well as some of the resulting consequences such as increased prevalence of HIV and hepatitis C virus. Access to prison-based harm reduction programing is thus important. The aim of this study was to learn from former prisoner experiences and insights on in-prison injection drug use in order to advance and improve access to harm reduction options, in particular prison-based needle and syringe programs (PNSPs). The qualitative and community-based study was conducted in 2014/2015 and included former prisoners from Ontario, Canada (N = 30) who had recent experience of incarceration in a federal prison and knowledge of injection drug use. Data analysis followed the deductive approach, drawing on the expertise of the academic and community-based research team members. Interview and focus group participants disclosed that drugs are readily available in Canadian federal prisons and that equipment used to inject is accessed in a variety of ways, sometimes gained through illicit means and sometimes made by prisoners themselves. Equipment sharing is a frequent occurrence, and disposal of such supplies is rare. Conclusions/Importance: While not yet available in Canada, PNSPs have led to positive outcomes in international contexts, including reductions in needle sharing and transmission of HIV and hepatitis C. Support for PNSPs among numerous Canadian organizations and associations, along with a recent change in government, could suggest a renewed opportunity for PNSP implementation.

Evaluation of certain veterinary drug residues in food. Eighty-first report of the Joint FAO/WHO Expert Committee on Food Additives.

Science.gov (United States)

2016-01-01

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including MRLs for generic fish species, acute reference doses (ARfDs) for veterinary drugs, an approach for dietary exposure assessment of compounds used for multiple purposes (i.e veterinary drugs and pesticides), dietary exposure assessment for less-than-lifetime exposure, and the assessment of short-term (90-day and 12-month) studies in dogs. Summaries follow of the Committee's evaluations of toxicological and residue data on a variety of veterinary drugs: two insecticides (diflubenzuron and teflubenzuron), an antiparasitic agent (ivermectin), an ectoparasiticide (sisapronil) and a β2-adrenoceptor agonist (zilpaterol hydrochloride). In addition, the Committee considered issues raised in concern forms from the Codex Committee on Residues of Veterinary Drugs in Foods on lasalocid sodium, an antiparasitic agent. Annexed to the report is a summary of the Committee's recommendations on these drugs, including acceptable daily intakes (ADIs), ARfDs and proposed MRLs.

77 FR 39390 - Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin

Science.gov (United States)

2012-07-03

..., Foods. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the... of use--(1) Dogs--(i) Amount. Administer 1.0 mg per kilogram (mg/kg) of body weight by subcutaneous...

41 CFR 102-41.220 - Is drug paraphernalia forfeited under 21 U.S.C. 863 available for transfer to other Federal...

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Is drug paraphernalia... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL... Personal Property Requiring Special Handling Drug Paraphernalia § 102-41.220 Is drug paraphernalia...

Adverse Drug Event Monitoring at the Food and Drug Administration: Your Report Can Make a Difference

OpenAIRE

Ahmad, Syed Rizwanuddin

2003-01-01

The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treati...

77 FR 5027 - Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to...

Science.gov (United States)

2012-02-01

...] Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to the... entitled ``Food and Drug Administration Transparency Initiative: Exploratory Program to [[Page 5028

Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals

International Nuclear Information System (INIS)

Kishore, R.

1990-01-01

The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)

77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

Science.gov (United States)

2012-07-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

Science.gov (United States)

2012-05-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2011-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...

77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

[The legislation of subjects of the Russian Federation concerning prevention of alcoholism, drug addiction and toxicomania].

Science.gov (United States)

2011-01-01

The article deals with analysis of the laws "On prevention of alcoholism, drug addiction and toxicomania" introduced in some subjects of the Russian Federation (Permskaya, Tomskaya, Murmanskaya oblast, the Republics of Bashkortostan, Mordovia, Buryatia, Mari El, etc.). The laws stipulate the participation of the authorities of public and municipal administration, public health, social protection, home affairs and others in the prevention activities. The integral part of this activity is the approval of corresponding regional programs with adequate financing and coordination. The laws on prevention of alcoholism, drug addiction and toxicomania, adopted in the subjects of the Russian Federation are of advance character and testify the necessity of adoption of relevant Federal law.

78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-04-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0642] Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-08-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Science.gov (United States)

2012-06-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2011-04-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...

75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2010-11-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...

76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2011-03-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...

76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2011-02-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2011-04-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

Science.gov (United States)

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2011-07-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...

76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

Science.gov (United States)

2011-08-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

77 FR 18830 - Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug...

Science.gov (United States)

2012-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0121] Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug... Food and Drug Administration to Incorporate Tobacco Products--Small Entity Compliance Guide'' to the...

To the Federal Trade Commission in the Matter of a Trade Regulation Rule on Food/Nutrition Advertising.

Science.gov (United States)

Choate, Robert B.

Food advertising and its effects on children are discussed in this document petitioning the Federal Trade Commission (FTC) to amend a proposed rule on food promotion for the benefit of children under twelve. Extensive information is presented on television food commercials and their influence on children's nutritional beliefs and eating habits.…

78 FR 54901 - Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel...

Science.gov (United States)

2013-09-06

.... Food and beverages will be available for purchase by participants during the workshop breaks. If you....regulations.gov . It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

Science.gov (United States)

2012-10-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

Science.gov (United States)

2011-05-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...

76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

Science.gov (United States)

2011-12-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

Science.gov (United States)

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

FDA approves efavirenz. Food and Drug Administration.

Science.gov (United States)

Highleyman, L

1998-10-01

The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

Launching a new food product or dietary supplement in the United States: industrial, regulatory, and nutritional considerations.

Science.gov (United States)

Finley, John Weldon; Finley, John Wescott; Ellwood, Kathleen; Hoadley, James

2014-01-01

Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. New foods/dietary supplements are often marketed by health claims or structure/function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions.

75 FR 70932 - Office of the Commissioner of Food and Drugs; Delegation of Authority

Science.gov (United States)

2010-11-19

... exercise of the authorities delegated herein prior to the effective date of this delegation. This... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Office of the Secretary... delegated to the Commissioner of Food and Drugs the authorities vested in the Secretary of Health and Human...

76 FR 16534 - New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction

Science.gov (United States)

2011-03-24

.... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction AGENCY: Food and...) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained...

75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

Science.gov (United States)

2010-09-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0459] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori; Availability AGENCY: Food...

Frequent food insecurity among injection drug users: correlates and concerns

Directory of Open Access Journals (Sweden)

Strike Carol

2012-12-01

Full Text Available Abstract Background Food insecurity and nutrition are two topics that are under-researched among injection drug users (IDUs. Our study examined the extent and correlates of food insecurity among a sample of IDUs and explored whether there is an association between food insecurity and injection-related HIV risk. Methods A cross-sectional survey was conducted using interviewer-administered questionnaires. Data were collected at a needle exchange program in London, Ontario, Canada between September 2006 and January 2007. Participants included 144 English-speaking IDUs who had injected drugs in the past 30 days. Participants were asked about their socio-demographic characteristics, HIV risk behaviours, food insecurity, and health/social service use. Results In the past 6 months, 54.5% of participants reported that on a daily/weekly basis they did not have enough to eat because of a lack of money, while 22.1% reported this type of food insecurity on a monthly basis. Moreover, 60.4% and 24.3% reported that they did not eat the quality or quantity of food they wanted on a daily/weekly or a monthly basis, respectively. Participants reported re-using someone else’s injection equipment: 21% re-used a needle, 19% re-used water, and 37.3% re-used a cooker. The odds of sharing injection equipment were increased for food insecure individuals. Conclusions Findings show that IDUs have frequent and variable experiences of food insecurity and these experiences are strongly correlated with sharing of injection-related equipment. Such behaviours may increase the likelihood of HIV and HCV transmission in this population. Addressing food-related needs among IDUs is urgently needed.

78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

Science.gov (United States)

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. Final rule.

Science.gov (United States)

2015-07-08

The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.

78 FR 14667 - New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N

Science.gov (United States)

2013-03-07

... Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and...-, 884-, or 1,768-milligram, or 4.42-gram capsules. (3) Conditions of use in dogs--(i) Amount. Administered capsules orally. Capsules containing 221 milligrams of n-butyl chloride are administered to dogs...

Kombucha brewing under the Food and Drug Administration model Food Code: risk analysis and processing guidance.

Science.gov (United States)

Nummer, Brian A

2013-11-01

Kombucha is a fermented beverage made from brewed tea and sugar. The taste is slightly sweet and acidic and it may have residual carbon dioxide. Kombucha is consumed in many countries as a health beverage and it is gaining in popularity in the U.S. Consequently, many retailers and food service operators are seeking to brew this beverage on site. As a fermented beverage, kombucha would be categorized in the Food and Drug Administration model Food Code as a specialized process and would require a variance with submission of a food safety plan. This special report was created to assist both operators and regulators in preparing or reviewing a kombucha food safety plan.

77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

Science.gov (United States)

2012-11-23

...; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1090...

75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

Science.gov (United States)

2010-06-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...

Evaluation of certain veterinary drug residues in food. Seventy-eighth report of the Joint FAO/WHO Expert Committee on Food Additives.

Science.gov (United States)

2014-01-01

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues of food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including extrapolation of maximum residue limits (MRLs) to minor species, MRLs for veterinary drug residues in honey, MRLs relating to fish and fish species, dietary exposure assessment methodologies, the decision-tree approach to the evaluation of residues of veterinary drugs and guidance for JECFA experts. Summaries follow of the Committee's evaluations of toxicology and residue data on a variety of veterinary drugs: two anthelminthic agents (derquantel, monepantel), three antiparasitic agents (emanectin benzoate, ivermectin, lasalocid sodium), one antibacterial, antifungal and anthelminthic agent (gentian violet), a production aid (recombinant bovine somatotropins) and an adrenoceptor agonist and growth promoter (zilpaterol hydorchloride). Annexed to the report is a summary of the Committee's recommendations on these drugs, including acceptable daily intakes (ADIs)) and proposed MRLs.

78 FR 42006 - Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol

Science.gov (United States)

2013-07-15

... associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. 200.... Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner... control of atopic dermatitis in dogs at least 12 months of age. (3) Limitations. Federal law restricts...

Interaction of Drug or Food with Drug Transporters in Intestine and Liver.

Science.gov (United States)

Nakanishi, Takeo; Tamai, Ikumi

2015-01-01

Oral bioavailability (F) is determined as fraction of the drug dose absorbed through the gastrointestinal membranes (Fa), the unmetabolized fraction of the absorbed dose that passes through the gut into the portal blood (Fg), and the hepatic first pass availability (Fh), namely F is expressed as the product of Fa, Fg and Fh (F = Fa.Fg.Fh). Current evidence suggests that transporter proteins play a role in intestinal absorption and hepatobiliary clearance of drugs. Among those transporters, this review will focus on PEPT1 and OATP2B1 as influx transporter and p-glycoprotein (P-gp) and BCRP as efflux transporter in intestinal epithelial cells, and on OATP1B1 and 1B3 as influx transporter and MRP2 as efflux transporter in hepatocytes, respectively, because drug-drug (DDI) and -food (DFI) interactions on these transporter are considered to affect bioavailability of their substrate drugs. DDI and DFI may reduce systemic exposure to drug by blocking influx transporters in intestine, but increase it by modulating influx and efflux transporters in liver and efflux transporters in intestines. Namely, drug disposition and efficacy are likely affected by DDI and DFI, resulting in treatment failures or increase in adverse effect. Therefore, it is of significantly importance to understand precise mechanism of DDI and DFI. This review will present information about transporter-based DDI and DFI in the processes of intestinal absorption and hepatic clearance of drugs, and discuss about their clinical implication.

Medical abortion practices : a survey of National Abortion Federation members in the United States

NARCIS (Netherlands)

Wiegerinck, Melanie M. J.; Jones, Heidi E.; O'Connell, Katharine; Lichtenberg, E. Steve; Paul, Maureen; Westhoff, Carolyn L.

2008-01-01

Background: Little is known about clinical implementation of medical abortion in the United States following approval of mifepristone as an abortifacient by the Food and Drug Administration (FDA) in 2000. We collected information regarding medical abortion practices of National Abortion Federation

Food irradiation developments in the Federal Republic of Germany

International Nuclear Information System (INIS)

Diehl, J.F.

1985-01-01

Professor Diehl from Karlsruhe describes work in the Federal Republic of Germany, based on 30 years of research work at the Centre for Nutrition at Karlsruhe. The replacement of toxic chemical preservatives by irradiation is an attractive possibility and permission for commercial spice irradiation is expected later this year. Promising results had been demonstrated for onions, tropical fruits, fish, shrimps, certain meats and enzymes. Prolonged wholesomeness studies has failed to reveal detrimental health effects up to 50 kGy. In spite of certain adverse political and emotional pressures the author is convinced that food irradiation will be permitted in all E.E.C. countries in the not too distant future

78 FR 52429 - Indirect Food Additives: Adhesives and Components of Coatings

Science.gov (United States)

2013-08-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 175 Indirect Food Additives: Adhesives and Components of Coatings CFR Correction In Title 21 of the Code of Federal Regulations, Parts 170 to 199, revised as of April 1, 2013, on page 196, in Sec. 175.320, in paragraph (c), in...

The central GLP-1: implications for food and drug reward

Directory of Open Access Journals (Sweden)

Karolina Patrycja Skibicka

2013-10-01

Full Text Available Glucagon-like-peptide-1 (GLP-1 and its long acting analogues comprise a novel class of type 2 diabetes (T2D treatment. What makes them unique among other T2D drugs is their concurrent ability to reduce food intake, a great benefit considering the frequent comorbidity of T2D and obesity. The precise neural site of action underlying this beneficial effect is vigorously researched. In accordance with the classical model of food intake control GLP-1 action on feeding has been primarily ascribed to receptor populations in the hypothalamus and the hindbrain. In contrast to this common view, relevant GLP-1 receptor populations are distributed more widely, with a prominent mesolimbic complement emerging. The physiological relevance of the mesolimbic GLP-1 is suggested by the demonstration that similar anorexic effects can be obtained by independent stimulation of the mesolimbic and hypothalamic GLP-1 receptors. Results reviewed here support the idea that mesolimbic GLP-1 receptors are sufficient to reduce hunger-driven feeding, the hedonic value of food and food-motivation. In parallel, emerging evidence suggests that the range of action of GLP-1 on reward behavior is not limited to food-derived reward but extends to cocaine, amphetamine and alcohol reward. The new discoveries concerning GLP-1 action on the mesolimbic reward system significantly extend the potential therapeutic range of this drug target.

Medical abortion practices: a survey of National Abortion Federation members in the United States

NARCIS (Netherlands)

Wiegerinck, Melanie M. J.; Jones, Heidi E.; O'Connell, Katharine; Lichtenberg, E. Steve; Paul, Maureen; Westhoff, Carolyn L.

2008-01-01

Little is known about clinical implementation of medical abortion in the United States following approval of mifepristone as an abortifacient by the Food and Drug Administration (FDA) in 2000. We collected information regarding medical abortion practices of National Abortion Federation (NAF) members

78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

Science.gov (United States)

2013-06-19

... inspections, and drive safety and quality throughout the supply chain. Implementation of these authorities... authorities granted to FDA under Title VII and their importance in ensuring drug safety, effectiveness, and.... FDA-2013-N-0683, FDA-2013-N-0684, and FDA-2013-N-0685] Food and Drug Administration Safety and...

76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Science.gov (United States)

2011-05-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-D-0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and...

77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Science.gov (United States)

2012-03-19

... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

Science.gov (United States)

2011-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0457] Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated... other electrical continence devices; protective garment for incontinence; surgical mesh; electrosurgical...

Short history of regulations and approved indications of antimicrobial drugs for food animals in the USA.

Science.gov (United States)

Volkova, V V; DeMars, Z

2017-06-01

We review historical availability and regulation, and recent indications of antimicrobial drugs for food animals in the USA. We summarize the timeline of introduction of individual antimicrobial drug classes from the 1930s to present, history of regulation of antimicrobial drugs from the 1930s to present and indications of antimicrobial drugs in 1996-2014 for food animals in the USA. The history of antimicrobial drug regulation demonstrates a historical precedent for harmonized regulations of antimicrobials 'for human and other animals' in the USA. © 2016 John Wiley & Sons Ltd.

77 FR 14272 - New Animal Drugs for Use in Animal Feeds

Science.gov (United States)

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2011, on page 490, in Sec. 558.500, (e)(1)(i) is reinstated to read as...

75 FR 15610 - New Animal Drugs for Use in Animal Feeds

Science.gov (United States)

2010-03-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2009, in Sec. 558.55, on page 408, at the end of the table to...

To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs.

Science.gov (United States)

Deng, Jiexin; Brar, Satjit S; Lesko, Lawrence J

2017-12-02

There has been controversy regarding whether bioavailability of certain oral oncology drugs should be maximized by taking these medications with food, irrespective of label instructions in the dosing and administration section. To provide insight into this controversy, we conducted an in-depth analysis for oral antineoplastic drugs approved by the Food and Drug Administration in 2000-2016 and identified important issues influencing food labeling decisions. Furthermore, a case study involving sonidegib, a drug approved for locally advanced basal cell carcinoma with a significant food effect on exposure, was used to demonstrate the consequences of failure to adhere to food label recommendations using drug-specific population pharmacokinetic and exposure-toxicity models. In 2000-2009, 80% (4 out of 5) of all approved oral antineoplastics with increased bioavailability in the fed state were labeled as "take on empty stomach." In contrast, we found that in 2010-2016 there is a greater diversity in food recommendations for drugs with increased bioavailability in the fed state. Currently, many oral oncology drugs are given with food to maximize their bioavailability; however, as seen from our case study of sonidegib, failure to fully adhere to label recommendations to either take with food or not could lead to adverse consequences in terms of safety and efficacy. © 2017, The American College of Clinical Pharmacology.

75 FR 37450 - Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing...

Science.gov (United States)

2010-06-29

... animals in order to help minimize antimicrobial resistance development. Based on a consideration of the...] Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals... Medically Important Antimicrobial Drugs in Food- Producing Animals.'' This draft guidance is intended to...

Food and drug reward: overlapping circuits in human obesity and addiction.

Science.gov (United States)

Volkow, N D; Wang, G J; Fowler, J S; Tomasi, D; Baler, R

2012-01-01

Both drug addiction and obesity can be defined as disorders in which the saliency value of one type of reward (drugs and food, respectively) becomes abnormally enhanced relative to, and at the expense of others. This model is consistent with the fact that both drugs and food have powerful reinforcing effects-partly mediated by dopamine increases in the limbic system-that, under certain circumstances or in vulnerable individuals, could overwhelm the brain's homeostatic control mechanisms. Such parallels have generated significant interest in understanding the shared vulnerabilities and trajectories between addiction and obesity. Now, brain imaging discoveries have started to uncover common features between these two conditions and to delineate some of the overlapping brain circuits whose dysfunctions may explain stereotypic and related behavioral deficits in human subjects. These results suggest that both obese and drug-addicted individuals suffer from impairments in dopaminergic pathways that regulate neuronal systems associated not only with reward sensitivity and incentive motivation, but also with conditioning (memory/learning), impulse control (behavioural inhibition), stress reactivity, and interoceptive awareness. Here, we integrate findings predominantly derived from positron emission tomography that shed light on the role of dopamine in drug addiction and in obesity, and propose an updated working model to help identify treatment strategies that may benefit both of these conditions.

Food and drug reward: overlapping circuits in human obesity and addiction

International Nuclear Information System (INIS)

Volkow, N.D.; Wang, G.J.; Fowler, J.S.; Tomasi, D.; Baler, R.

2012-01-01

Both drug addiction and obesity can be defined as disorders in which the saliency value of one type of reward (drugs and food, respectively) becomes abnormally enhanced relative to, and at the expense of others. This model is consistent with the fact that both drugs and food have powerful reinforcing effects - partly mediated by dopamine increases in the limbic system - that, under certain circumstances or in vulnerable individuals, could overwhelm the brain's homeostatic control mechanisms. Such parallels have generated significant interest in understanding the shared vulnerabilities and trajectories between addiction and obesity. Now, brain imaging discoveries have started to uncover common features between these two conditions and to delineate some of the overlapping brain circuits whose dysfunctions may explain stereotypic and related behavioral deficits in human subjects. These results suggest that both obese and drug addicted individuals suffer from impairments in dopaminergic pathways that regulate neuronal systems associated not only with reward sensitivity and incentive motivation, but also with conditioning (memory/learning), impulse control (behavioral inhibition), stress reactivity and interoceptive awareness. Here, we integrate findings predominantly derived from positron emission tomography that investigate the role of dopamine in drug addiction and in obesity and propose an updated working model to help identify treatment strategies that may benefit both of these conditions.

Food and drug reward: overlapping circuits in human obesity and addiction

Energy Technology Data Exchange (ETDEWEB)

Volkow N. D.; Wang G.; Volkow, N.D.; Wang, G.-J.; Fowler, J.S.; Tomasi, D.; Baler, R.

2012-12-01

Both drug addiction and obesity can be defined as disorders in which the saliency value of one type of reward (drugs and food, respectively) becomes abnormally enhanced relative to, and at the expense of others. This model is consistent with the fact that both drugs and food have powerful reinforcing effects - partly mediated by dopamine increases in the limbic system - that, under certain circumstances or in vulnerable individuals, could overwhelm the brain's homeostatic control mechanisms. Such parallels have generated significant interest in understanding the shared vulnerabilities and trajectories between addiction and obesity. Now, brain imaging discoveries have started to uncover common features between these two conditions and to delineate some of the overlapping brain circuits whose dysfunctions may explain stereotypic and related behavioral deficits in human subjects. These results suggest that both obese and drug addicted individuals suffer from impairments in dopaminergic pathways that regulate neuronal systems associated not only with reward sensitivity and incentive motivation, but also with conditioning (memory/learning), impulse control (behavioral inhibition), stress reactivity and interoceptive awareness. Here, we integrate findings predominantly derived from positron emission tomography that investigate the role of dopamine in drug addiction and in obesity and propose an updated working model to help identify treatment strategies that may benefit both of these conditions.

75 FR 20268 - Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Propofol

Science.gov (United States)

2010-04-19

... 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under... use in dogs and cats--(1) Amount. The drug is administered by intravenous injection as follows: (i) Dogs. For induction of general anesthesia without the use of preanesthetics the dosage is 5.5 to 7.0 mg...

Regulatory aspects of teratology: role of the Food and Drug Administration

International Nuclear Information System (INIS)

Kelsey, F.O.

1982-01-01

The Food and Drug Administration is a scientific regulatory agency whose consumer protection activities cover a wide range of products including foods and additives, and pesticide residues on foods; drugs; cosmetics; medical devices; and radiation-emitting electronic products. Amongst its concerns is the possible teratogen effects of regulated products to which the pregnant woman is exposed. The policies and programs of the agency directed toward reducing such risks to the unborn are reviewed. These measures include guidelines for animal reproduction studies and for clinical trials involving women to childbearing potential; labeling of products to disclose known or possible harm to the fetus or embryo; surveillance procedures designed to detect previously unsuspected adverse effects of marketed products; research activities designed to develop better understanding of developmental toxicology and improved techniques for detecting embryocidal and embryotoxic effects; and educational efforts directed both to professionals and the public regarding hazards to the unborn of agency-regulated products

Biopharming, bananas and bureaucracy: the banana vaccine as a case study for products that straddle the definitional food/drug divide.

Science.gov (United States)

Birdsall, Margaux

2011-01-01

This paper examines the definition of the terms "food" and "drug" as used in the Food, Drug and Cosmetic Act through the lens of biopharmed products. The paper uses the so-called "banana vaccine" as a case study to highlight the problems that occur when attempting to regulate a product that could be safely used as a food or as a drug. Specifically, the examination of this model illustrates the problems in the current definitional scheme. The paper considers how a product that straddles the definitional line between food and drug could be regulated and proposes a reformation to how the definitions are applied to products to better suit new technology in food and drugs.

Factors Associated with Potential Food-Drug Interaction in Hospitalized Patients: A Cross-Sectional Study in Northeast Iran

Directory of Open Access Journals (Sweden)

Mostafa Abdollahi

2018-04-01

Full Text Available Background: The minimization of adverse food-drug interactions will improve patient care by optimizing the therapeutic effects and maintaining proper nutritional status. Aim: The aim of the present study was to find the main factors that may place the hospitalized patients at risk of potential food-drug interactions. Method: This cross-sectional, descriptive study was conducted on 400 inpatients admitted to the Department of Internal Medicine of a teaching hospital in Mashhad, Northeast Iran, within 20 March 2013 to 20 April 2013. The potential food-drug interactions were evaluated for 19 commonly prescribed medications. The main factors (e.g., age, gender, education level, number of medications, and duration of the disease that may place the patients at risk of potential food-drug interactions were analyzed for each patient. Results: Out of the 19 commonly prescribed medications, 17 drugs (89% were not properly used with respect to meal. Furthermore, 14 commonly prescribed drugs were found to have a high frequency (≥50% of potential food-drug interactions. Most of the patients (n=359, 89.8% consumed their medicines at inappropriate time with respect to meals. The results of a multiple logistic regression after adjustment for confounders revealed that the age [β=0.005, CI: 0.0-0.01; P=033], number of medications [β=0.1, CI: 0.083-0.117; P

21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testing and research conducted by or with funds... Categories of Records § 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration. (a) Any list that may be prepared by the Food and Drug Administration of testing and research...

Characterizing chronic and acute health risks of residues of veterinary drugs in food: latest methodological developments by the joint FAO/WHO expert committee on food additives.

Science.gov (United States)

Boobis, Alan; Cerniglia, Carl; Chicoine, Alan; Fattori, Vittorio; Lipp, Markus; Reuss, Rainer; Verger, Philippe; Tritscher, Angelika

2017-11-01

The risk assessment of residues of veterinary drugs in food is a field that continues to evolve. The toxicological end-points to be considered are becoming more nuanced and in light of growing concern about the development of antimicrobial resistance, detailed analysis of the antimicrobial activity of the residues of veterinary drugs in food is increasingly incorporated in the assessment. In recent years, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has refined its approaches to provide a more comprehensive and fit-for-purpose risk assessment. This publication describes in detail the consideration of acute and chronic effects, the estimation of acute and chronic dietary exposure, current approaches for including microbiological endpoints in the risk assessment, and JECFA's considerations for the potential effects of food processing on residues from veterinary drugs. JECFA now applies these approaches in the development of health-based guidance values (i.e. safe exposure levels) for residues of veterinary drugs. JECFA, thus, comprehensively addresses acute and chronic risks by using corresponding estimates for acute and chronic exposure and suitable correction for the limited bioavailability of bound residues by the Gallo-Torres model. On a case-by-case basis, JECFA also considers degradation products that occur from normal food processing of food containing veterinary drug residues. These approaches will continue to be refined to ensure the most scientifically sound basis for the establishment of health-based guidance values for veterinary drug residues.

21 CFR 201.303 - Labeling of drug preparations containing significant proportions of wintergreen oil.

Science.gov (United States)

2010-04-01

... proportions of wintergreen oil. (a) Because methyl salicylate (wintergreen oil) manifests no toxicity in the... poisoning. (c) This statement of interpretation in no way exempts methyl salicylate (wintergreen oil) or its... provisions of the Federal Food, Drug, and Cosmetic Act any drug containing more than 5 percent methyl...

75 FR 31450 - Memorandum of Understanding by and Between the United States Food and Drug Administration and the...

Science.gov (United States)

2010-06-03

... Administration and the International Anesthesia Research Society for the Safety of Key Inhaled and Intravenous Drugs in Pediatrics Public-Private Partnership AGENCY: Food and Drug Administration, HHS. ACTION: Notice... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004...

Food security and nutrition in the Russian Federation – a health policy analysis

Directory of Open Access Journals (Sweden)

Karsten Lunze

2015-06-01

Full Text Available Background: In the Russian Federation (Russia, an elevated burden of premature mortality attributable to non-communicable diseases (NCDs has been observed since the country's economic transition. NCDs are largely related to preventable risk factors such as unhealthy diets. Objective: This health policy study's aim was to analyze past and current food production and nutritional trends in Russia and their policy implications for Russia's NCD burden. Design: We examined food security and nutrition in Russia using an analytical framework of food availability, access to food, and consumption. Results: Agricultural production declined during the period of economic transition, and nutritional habits changed from high-fat animal products to starches. However, per-capita energy consumption remained stable due to increased private expenditures on food and use of private land. Paradoxically, the prevalence of obesity still increased because of an excess consumption of unsaturated fat, sugar, and salt on one side, and insufficient intake of fruit and vegetables on the other. Conclusions: Policy and economic reforms in Russia were not accompanied by a food security crisis or macronutrient deprivation of the population. Yet, unhealthy diets in contemporary Russia contribute to the burden of NCDs and related avoidable mortality. Food and nutrition policies in Russia need to specifically address nutritional shortcomings and food-insecure vulnerable populations. Appropriate, evidence-informed food and nutrition policies might help address Russia's burden of NCDs on a population level.

Bioethical differences between drug addiction treatment professionals inside and outside the Russian Federation

Directory of Open Access Journals (Sweden)

Mendelevich Vladimir D

2011-06-01

Full Text Available Abstract This article provides an overview of a sociological study of the views of 338 drug addiction treatment professionals. A comparison is drawn between the bioethical approaches of Russian and foreign experts from 18 countries. It is concluded that the bioethical priorities of Russian and foreign experts differ significantly. Differences involve attitudes toward confidentiality, informed consent, compulsory treatment, opioid agonist therapy, mandatory testing of students for psychoactive substances, the prevention of mental patients from having children, harm reduction programs (needle and syringe exchange, euthanasia, and abortion. It is proposed that the cardinal dissimilarity between models for providing drug treatment in the Russian Federation versus the majority of the countries of the world stems from differing bioethical attitudes among drug addiction treatment experts.

Healthy Foods, Healthy Families: combining incentives and exposure interventions at urban farmers' markets to improve nutrition among recipients of US federal food assistance.

Science.gov (United States)

Bowling, April B; Moretti, Mikayla; Ringelheim, Kayla; Tran, Alvin; Davison, Kirsten

2016-01-01

Healthy Foods, Healthy Families (HFHF) is a fruit and vegetable (F&V) exposure/incentive program implemented at farmers' markets in low-income neighborhoods, targeting families receiving US federal food assistance. We examined program effects on participants' diet and associations between attendance, demographics and dietary change. Exposure activities included F&V tastings and cooking demonstrations. Incentives included 40% F&V bonus for electronic benefit transfer (EBT) card users and $20 for use purchasing F&V at every third market visit. Self-report surveys measuring nutritional behaviors/literacy were administered to participants upon enrollment (n = 425, 46.2% Hispanic, 94.8%female). Participants were sampled for follow-up at markets during mid-season (n = 186) and at season end (n = 146). Attendance was tracked over 16 weeks. Participants post-intervention reported significantly higher vegetable consumption(P = 0.005) and lower soda consumption (P = 0.005). Participants reporting largest F&V increases attended the market 6-8 times and received $40 in incentives. No change in food assistance spent on F&V (P = 0.94); 70% reported significant increases in family consumption of F&V,indicating subsidies increased overall F&V purchasing. Participants reported exposure activities and incentives similarly affected program attendance. Interventions combining exposure activities and modest financial incentives at farmers' markets in low-income neighborhoods show strong potential to improve diet quality of families receiving federal food assistance.

The safety and regulation of natural products used as foods and food ingredients.

Science.gov (United States)

Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

2011-10-01

The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.

Screening of veterinary drug residues in food by LC-MS/MS. Background and challenges.

Science.gov (United States)

Delatour, Thierry; Racault, Lucie; Bessaire, Thomas; Desmarchelier, Aurélien

2018-04-01

Regulatory agencies and government authorities have established maximum residue limits (MRL) in various food matrices of animal origin for supporting governments and food operators in the monitoring of veterinary drug residues in the food chain, and ultimately in the consumer's plate. Today, about 200 veterinary drug residues from several families, mainly with antibiotic, antiparasitic or antiinflammatory activities, are regulated in a variety of food matrices such as milk, meat or egg. This article provides a review of the regulatory framework in milk and muscle including data from Codex Alimentarius, Europe, the U.S.A., Canada and China for about 220 veterinary drugs. The article also provides a comprehensive overview of the challenge for food control, and emphasizes the pivotal role of liquid chromatography-mass spectrometry (LC-MS), either in tandem with quadrupoles (LC-MS/MS) or high resolution MS (LC-HRMS), for ensuring an adequate consumer protection combined with an affordable cost. The capability of a streamlined LC-MS/MS platform for screening 152 veterinary drug residues in a broad range of raw materials and finished products is highlighted in a production line perspective. The rationale for a suite of four methods intended to achieve appropriate performance in terms of scope and sensitivity is presented. Overall, the platform encompasses one stream for the determination of 105 compounds in a run (based on acidic QuEChERS-like), plus two streams for 23 β-lactams (alkaline QuEChERS-like) and 10 tetracyclines (low-temperature partitioning), respectively, and a dedicated stream for 14 aminoglycosides (molecularly-imprinted polymer).

78 FR 9701 - Draft Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of...

Science.gov (United States)

2013-02-11

... on the sources of L. monocytogenes contamination, the effects of individual manufacturing and/or... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1182] Draft Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of...

76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2011-08-09

... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Science.gov (United States)

2010-09-28

... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

Science.gov (United States)

2010-04-01

..., powdered extract Betaine hydrochloride Bismuth subcarbonate Bismuth subgallate Black radish powder Blessed... Pineapple enzymes Plantago seed Potassium citrate Pyridoxine hydrochloride (vitamin B6) Riboflavin Rice... the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application under...

U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

Science.gov (United States)

Wing, Deborah A; Powers, Barbara; Hickok, Durlin

2010-04-01

The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development. We review the process for drug approval and recount the approval histories of obstetric drugs reviewed in the recent past. We also outline the current status of two progestational agents that are under development. For a variety of reasons, including a small market compared with others such as cardiology or oncology, and the potential of being drawn into medical-legal litigation, sponsors are disinclined to pursue drug development for obstetric purposes in this country. We compare the procedures for review and approval of drugs in the United States with those in Europe, and note that recent changes within the FDA may result in not only more drugs being approved but also changes in labeling of already approved drugs. Special programs to facilitate drug development and reforms to modernize the process and improve safety are discussed. These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed.

75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2010-11-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...

Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration.

Directory of Open Access Journals (Sweden)

Helen W Sullivan

Full Text Available The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA. Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001-2014. We examined the frequency of submissions by audience (consumer and healthcare professional and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources.

Local food policies can help promote local foods and improve health: a case study from the Federated States of Micronesia.

Science.gov (United States)

Englberger, Lois; Lorens, Adelino; Pretrick, Moses; Tara, Mona J; Johnson, Emihner

2011-11-01

The Federated States of Micronesia (FSM) and other countries throughout the Pacific are facing an epidemic of non-communicable disease health problems. These are directly related to the increased consumption of unhealthy imported processed foods, the neglect of traditional food systems, and lifestyle changes, including decreased physical activity. The FSM faces the double burden of malnutrition with both non-communicable diseases and micronutrient deficiencies, including vitamin A deficiency and anemia. To help increase the use of traditional island foods and improve health, the Island Food Community of Pohnpei has initiated a program in the FSM to support and promote local food policies, along with its Go Local awareness campaign. Such local food policies are defined broadly and include individual and family commitments, community group local food policies and policies established by government, including presidential proclamations and increased taxation on soft drinks. The aim of this paper is to describe this work. An inter-agency, community- and research-based, participatory and media approach was used. Partners are both non-governmental and governmental. The use of continuing awareness work along with local food policy establishment and the acknowledgement of the individuals and groups involved are essential. The work is still in the preliminary stage but ad hoc examples show that this approach has had success in increased awareness on health issues and improving dietary intake on both an individual and group basis. This indicates that further use of local food policies could have an instrumental impact in FSM as well as other Pacific Island countries in promoting local foods and improving dietary intake and health, including the control of non-communicable diseases and other dietary-related health problems.

Food and Drug Administration Evaluation and Cigarette Smoking Risk Perceptions

Science.gov (United States)

Kaufman, Annette R.; Waters, Erika A.; Parascandola, Mark; Augustson, Erik M.; Bansal-Travers, Maansi; Hyland, Andrew; Cummings, K. Michael

2011-01-01

Objectives: To examine the relationship between a belief about Food and Drug Administration (FDA) safety evaluation of cigarettes and smoking risk perceptions. Methods: A nationally representative, random-digit-dialed telephone survey of 1046 adult current cigarette smokers. Results: Smokers reporting that the FDA does not evaluate cigarettes for…

Methodology for the U.S. Food and Drug Administration's radionuclides in foods program

International Nuclear Information System (INIS)

Baratta, E.J.

1998-01-01

The U.S. Food and Drug Administration (FDA) is responsible for the wholesomeness of the nation's food supply. The FDA modified its food monitoring program in January, 1973, to include radioactive isotopes. The methodology used to perform analyses on these food products are taken from the standard setting societies such as the AOAC International, American Society for Testing Materials and American Public Health Association Standard Methods. In addition, methods not tested by these societies are taken from the literature or from Department of Energy manuals such as the Health and Safety Laboratory and also from Environmental Protection Agency, Public Health Service, and Food and Agricultural Organization manuals. These include the methods for long-lived radionuclides such as tritium, strontium-90, cesium-137 and plutonium. Also, the short-lived radionuclides such as iodine-131, radiocesium, radiocerium and radioruthenium. In addition, they include the natural occurring radionuclides such as radium and uranium isotopes. The activity concentrations of gamma-emitters such as radiocesium, iodine-131 and radioruthenium are determined by gamma-ray spectrometry. This is done using intrinsic germanium detectors with the appropriate hardware and software. The alpha and 'pure' beta-emitters are determined by various radiochemical methods and techniques. The radiochemical methodology and equipment used in analyzing these radionuclides are described and discussed. Also, the methodology and equipment for the gamma-emitters are described in more detail in this paper. In addition, the limits of detection for the methods used will be discussed. (author)

Piloting social engagement on a federal agency-administered Facebook page.

Science.gov (United States)

Chiu, Kimberly; Wagner, Lindsay; Choe, Lena; Chew, Catherine; Kremzner, Mary

2016-01-01

To evaluate the impact of a Federal drug information center initiating engagement with stakeholders on a Facebook Page administered by a Federal Agency. The U.S. Food and Drug Administration (FDA) Facebook page from July 21, 2014, to October 18, 2014. FDA's Division of Drug Information (DDI) in the Center for Drug Evaluation and Research (CDER) Office of Communications serves as a federal drug information center providing timely, accurate, and useful information on CDER initiatives and CDER-regulated products. We report a 90-day (July 21 to October 18, 2014) pilot during which DDI pharmacists monitored and moderated comments received on FDA's Facebook page to identify those warranting a reply. Once identified, DDI pharmacists replied within 2 business days. Impact was measured by comparing the average number of Likes, Shares, and Reach for Facebook posts before and after the pilot. Additional metrics collected include the number of DDI replies provided to stakeholders' comments and the number of DDI replies provided on time (within 2 business days). During the pilot, DDI contributed 14 posts. On average, each post reached 23,582 more individuals (an increase of 187% compared with pre-pilot posts). On average, each post also received 463 more Likes (450% increase) and 130 more Shares (271% increase). DDI pharmacists replied to 3% (121/3994) and hid 0.58% (23/3994) of Facebook comments received during the 90-day period. All actions were taken within 2 business days. Initiating social engagement had a positive impact on FDA's Facebook page. Published by Elsevier Inc.

77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

Science.gov (United States)

2012-04-06

...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...

Development of irradiation technique on degradation residue of pesticide veterinary drugs and mycotoxins in food

International Nuclear Information System (INIS)

He Jiang; Huang Min; Chen Hao; Wu Ling; Gao Peng; Wang Yan; Lei Qing

2011-01-01

Irradiation technology is a new processing technology, It was widely used in food, medicines and medical supplies, chemical and other industries. In this paper, illustrated their applications in the degradation of pesticides, veterinary drugs and mycotoxins aspects residual pollution in food. Analysis of residual contaminants in food irradiation control study limitations and look forward to the prospect of food irradiation technology. (authors)

The neuropharmacology of relapse to food seeking: methodology, main findings, and comparison with relapse to drug seeking.

Science.gov (United States)

Nair, Sunila G; Adams-Deutsch, Tristan; Epstein, David H; Shaham, Yavin

2009-09-01

Relapse to old, unhealthy eating habits is a major problem in human dietary treatments. The mechanisms underlying this relapse are unknown. Surprisingly, until recently this clinical problem has not been systematically studied in animal models. Here, we review results from recent studies in which a reinstatement model (commonly used to study relapse to abused drugs) was employed to characterize the effect of pharmacological agents on relapse to food seeking induced by either food priming (non-contingent exposure to small amounts of food), cues previously associated with food, or injections of the pharmacological stressor yohimbine. We also address methodological issues related to the use of the reinstatement model to study relapse to food seeking, similarities and differences in mechanisms underlying reinstatement of food seeking versus drug seeking, and the degree to which the reinstatement procedure provides a suitable model for studying relapse in humans. We conclude by discussing implications for medication development and future research. We offer three tentative conclusions: (1)The neuronal mechanisms of food-priming- and cue-induced reinstatement are likely different from those of reinstatement induced by the pharmacological stressor yohimbine. (2)The neuronal mechanisms of reinstatement of food seeking are possibly different from those of ongoing food-reinforced operant responding. (3)The neuronal mechanisms underlying reinstatement of food seeking overlap to some degree with those of reinstatement of drug seeking.

Honey: Single food stuff comprises many drugs

Directory of Open Access Journals (Sweden)

Shahid Ullah Khan

2018-02-01

Full Text Available Honey is a natural food item produced by honey bees. Ancient civilizations considered honey as a God gifted prestigious product. Therefore, a huge literature is available regarding honey importance in almost all religions. Physically, honey is a viscous and jelly material having no specific color. Chemically, honey is a complex blend of many organic and inorganic compounds such as sugars, proteins, organic acids, pigments, minerals, and many other elements. Honey use as a therapeutic agent is as old as human civilization itself. Prior to the appearance of present day drugs, honey was conventionally used for treating many diseases. At this instant, the modern research has proven the medicinal importance of honey. It has broad spectrum anti-biotic, anti-viral and anti-fungal activities. Honey prevents and kills microbes through different mechanism such as elevated pH and enzyme activities. Till now, no synthetic compound that works as anti-bacterial, anti-viral and anti-fungal drugs has been reported in honey yet it works against bacteria, viruses and fungi while no anti-protozoal activity has been reported. Potent anti-oxidant, anti-inflammatory and anti-cancerous activities of honey have been reported. Honey is not only significant as anti-inflammatory drug that relieve inflammation but also protect liver by degenerative effects of synthetic anti-inflammatory drugs. This article reviews physico-chemical properties, traditional use of honey as medicine and mechanism of action of honey in the light of modern scientific medicinal knowledge.

[Legal development of consumer protection from the Federal Office of Consumer Protection and Food Safety standpoint].

Science.gov (United States)

Püster, M

2010-06-01

Ten years after publication of the White Paper on Food Safety, health consumer protection has made significant progress and, today, is a key field in politics at both the European and German levels. In addition to the protection of health and security of consumers, consumer information has become a core element of consumer protection for the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz and Lebensmittelsicherheit, BVL). State authorities are provided with new means of communication and interaction with consumers.

The healthfulness of food and beverage purchases after the federal food package revisions: The case of two New England states.

Science.gov (United States)

Andreyeva, Tatiana; Tripp, Amanda S

2016-10-01

In 2009, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) implemented new food packages to improve dietary intake among WIC participants. This paper examines how the healthfulness of food purchases among low-income households changed following this reform. Point-of-sale data for 2137 WIC-participating and 1303 comparison households were obtained from a regional supermarket chain. The healthfulness of purchased foods and beverages was determined per their saturated fat, sugar, and sodium content. A pre-post assessment (2009-2010) of the product basket healthfulness was completed using generalized estimating equation models. Data were analyzed in 2015. At baseline, healthy products accounted for most of the food volume purchased by WIC participants, but beverages were dominated by moderation (less healthy) items. With new subsidies for fruit, vegetables and whole grains, the WIC revisions increased the volume of healthy food purchases of WIC-participating households by 3.9% and reduced moderation foods by 1.8%. The biggest improvements were reductions in moderation beverages (down by 24.7% in volume), driven by milk fat restrictions in the WIC food package revisions. The healthfulness of the product basket increased post-WIC revisions; mainly due to a reduction in the volume of moderation food and beverages purchased (down by 15.5%) rather than growth in healthy products (up by 1.9%). No similar improvements were seen in a comparison group of low-income nonparticipants. After the WIC revisions, the healthfulness of participant purchases improved, particularly for beverages. Efforts to encourage healthy eating by people receiving federal food assistance are paying off. Copyright © 2016 Elsevier Inc. All rights reserved.

78 FR 76842 - Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel...

Science.gov (United States)

2013-12-19

... 866-561-8558 (toll free). Food and beverages will be available for purchase by participants during the... accessible at http://www.regulations.gov . It may be viewed at the Division of Dockets Management, Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

Food labeling; calorie labeling of articles of food in vending machines. Final rule.

Science.gov (United States)

2014-12-01

To implement the vending machine food labeling provisions of the Patient Protection and Affordable Care Act of 2010 (ACA), the Food and Drug Administration (FDA or we) is establishing requirements for providing calorie declarations for food sold from certain vending machines. This final rule will ensure that calorie information is available for certain food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase. The declaration of accurate and clear calorie information for food sold from vending machines will make calorie information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices. This final rule applies to certain food from vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines. Vending machine operators not subject to the rules may elect to be subject to the Federal requirements by registering with FDA.

75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

Science.gov (United States)

2010-11-12

... annually from approximately 25 application holders. FDA professionals familiar with Dear Health Care... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0319] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters...

Medical Services: DoD Hazardous Food and Nonprescription Drug Recall System

Science.gov (United States)

1986-08-15

This publication implements policy of the Office of the Under Secretary of Defense for Research and Engineering for the establishment of a hazardous ... food and nonprescription drug recall system. It has been coordinated with and concurred in by the DMSB and the Services.

78 FR 9928 - Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

Science.gov (United States)

2013-02-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0124... metrics. With that in mind, FDA would like input on the following issues: What metrics do manufacturers... been suggested as a potentially useful approach to expanding manufacturing capacity and preventing...

Drug-Food Interactions

Science.gov (United States)

... Conditions Prevention and Wellness Staying Healthy Healthy Living Travel Occupational Health First Aid and Injury Prevention Crisis Situations Pets and Animals myhealthfinder Food and Nutrition Healthy Food Choices Weight Loss and ...

Recalls of foods due to microbiological contamination classified by the U.S. Food and Drug Administration, fiscal years 2003 through 2011.

Science.gov (United States)

Dey, Manashi; Mayo, Jonathan A; Saville, Deborah; Wolyniak, Cecilia; Klontz, Karl C

2013-06-01

Recalls of foods contaminated with pathogens help reduce the transmission of infectious diseases. Here, we summarize the number and nature of foods recalled as a result of microbiological contamination, classified by the U.S. Food and Drug Administration for the period 1 October 2002 through 30 September 2011. Microbiological contamination accounted for 1,395 (42%) of 3,360 recalls of food during this period. Nuts and edible seeds, followed by fishery-seafood products and spices, were the types of products most commonly recalled for microbiological contamination. Salmonella contamination accounted for the greatest number of food products recalled due to microbiological contamination, and was the pathogen most often linked to reported outbreaks involving recalled food products.

Needs of food irradiation and its commercialization

Energy Technology Data Exchange (ETDEWEB)

Welt, M A

1984-01-01

On July 5, 1983, the United States Food and Drug Administration filed a notice in the Federal Register approving the use of cobalt 60 or cesium 137 gamma radiation to reduce or control microbial contamination in spices, onion powder and garlic powder. The approval was the first in nineteen years issued by the FDA and appears to set the stage for increased regulatory approvals in the area of radiation preservation of foods. On July 8, 1983, the Codex Alimentarius Commission approved an international standard for irradiated foods. The standard had previously been introduced by experts in the World Health Organization and the Food and Agriculture Organization. The ability of properly applied ionizing energy to inhibit sprouting, to eliminate the need for toxic chemical fumigants for insect disinfestation purposes, to extend refrigerated shelf life of many food products, to eliminate parasites and pathogens from our food chain and to preserve precooked packaged food products for indefinite storage without freezing or refrigeration, dictates the timeliness of food irradiation technology.

75 FR 4407 - Science Board to the Food and Drug Administration; Notice of Meeting

Science.gov (United States)

2010-01-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... subcommittee reviewing research at the Center for Food Safety and Applied Nutrition. The Science Board will... person on or before Monday, February 15, 2010. Oral presentations from the public will be scheduled...

Simulated food effects on drug release from ethylcellulose: PVA-PEG graft copolymer-coated pellets.

Science.gov (United States)

Muschert, Susanne; Siepmann, Florence; Leclercq, Bruno; Carlin, Brian; Siepmann, Juergen

2010-02-01

Food effects might substantially alter drug release from oral controlled release dosage forms in vivo. The robustness of a novel type of controlled release film coating was investigated using various types of release media and two types of release apparatii. Importantly, none of the investigated conditions had a noteworthy impact on the release of freely water-soluble diltiazem HCl or slightly water-soluble theophylline from pellets coated with ethylcellulose containing small amounts of PVA-PEG graft copolymer. In particular, the presence of significant amounts of fats, carbohydrates, surfactants, bile salts, and calcium ions in the release medium did not alter drug release. Furthermore, changes in the pH and differences in the mechanical stress the dosage forms were exposed to did not affect drug release from the pellets. The investigated film coatings allowing for oral controlled drug delivery are highly robust in vitro and likely to be poorly sensitive to classical food effects in vivo.

Your business in court and at federal agencies: 2010 - 2011.

Science.gov (United States)

Reiss, John B; Crowder, Dawn; Simons, Brian; Pleskov, Igor; Davis, Tiffany; Nugent, Patrick

2012-01-01

This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as under the provisions of the Food, Drug and Cosmetics Act (FDCA). In addition, the government pursued actions against individual executives under the Responsible Corporate Officer Doctrine ("RCO Doctrine") because it does not believe sanctions against the companies provide sufficient deterrence to inappropriate behavior. Companies need to focus on implementing effective compliance programs in order to prevent the occurrence of allegedly improper activity. It should be noted that the existence of an effective program will not protect executives from liability under the RCO Doctrine if improper behavior takes place. The Food and Drug Administration's (FDA's) has undertaken a number of initiatives during the past year in an attempt to counter claims that its review processes for domestic products is driving the development of drugs and devices to overseas markets. The Agency also has improved its capacity to review products imported from overseas by undertaking initiatives with foreign agencies and stationing more FDA employees in foreign countries. The FDA increased the number of warning letters and other enforcement actions. The FDA added two new topics of enhanced authority during the year. One was an expansion of its regulatory authority over foods, and the second was new authority to regulate certain tobacco products. The former is being subjected to some review by the courts, and the scope of its authority over tobacco is the subject of ongoing major litigation. The Federal Trade Commission (FTC) and Securities and Exchange Commission (SEC) are unlikely to experience significant change regarding their regulation of Manufacturers. The FTC, as it has for many years, continues to try to prevent "reverse" payments to generic drug manufacturers by Innovator Manufacturers to diminish generic drug competition, and proposed legislation is

U.S. Food and Drug Administration's dioxin monitoring program

Energy Technology Data Exchange (ETDEWEB)

South, P.; S. Kathleen Egan; Troxell, T.; P. Michael Bolger [U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park (United States)

2004-09-15

Dioxin-like compounds (DLCs) are a group of environmental contaminants whose primary route of human exposure occurs via the consumption of fatty foods of animal origin. Recent safety risk assessments conducted by national and international organizations broadly agree that risk management actions should be developed to decrease DLC exposure. Since the mid-1990s, the U.S. Food and Drug Administration (FDA) has tested specific foods with the goal of describing and reducing DLC exposure. In 2001, FDA developed a strategy for DLCs (http://vm.cfsan.fda.gov/{proportional_to}lrd/dioxstra.html) and substantially expanded its dioxin monitoring program to obtain more comprehensive data on background levels of DLCs in specific food and feed samples as well as to identify and reduce pathways of DLC contamination. FDA's dioxin monitoring program analyzes food collected under its Total Diet Study (TDS) and food and feed from targeted sampling. The TDS is FDA's ongoing market basket survey of approximately 280 core foods in the U.S. food supply. FDA targeted sampling collects and analyzes foods suspected of having both higher DLC levels and more variability in those levels than other foods. The contribution of dietary DLCs to overall exposure and the possible introduction of DLCs in animalbased food via the use of particular feed components was recently identified by the National Academy of Sciences Committee on the Implications of Dioxin in the Food Supply and confirmed FDA's approach articulated in its dioxin strategy.

Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences.

Science.gov (United States)

Mochel, J P; Tyden, E; Hellmann, K; Vendrig, J C; Şenel, S; Dencker, L; Cristina, R T; Linden, H; Schmerold, I

2018-06-01

The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems. © 2017 John Wiley & Sons Ltd.

21 CFR 201.115 - New drugs or new animal drugs.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false New drugs or new animal drugs. 201.115 Section 201.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Exemptions From Adequate Directions for Use § 201.115 New drugs or new animal...

Federal radiation initiatives wane in Reagan administration

International Nuclear Information System (INIS)

Linton, O.W.

1981-01-01

A series of administrative initiatives undertaken by the Carter Administration in response to public concerns about harmful effects of exposures to ionizing radiation in various settings has been abandoned by the Reagan Administration. The decision to discard the Radiation Policy Council, the coordinating agency established in 1980, leaves the federal government with no overall focus or overall budget for radiation research and protection activities. The line agencies with direct radiation responsibilities, including the Department of Energy, Nuclear Regulatory Commission, Department of Defense, Food and Drug Administration's Bureau of Radiological health, and Department of Labor, continue with somewhat contradictory and uncoordinated programs

Automated identification of drug and food allergies entered using non-standard terminology.

Science.gov (United States)

Epstein, Richard H; St Jacques, Paul; Stockin, Michael; Rothman, Brian; Ehrenfeld, Jesse M; Denny, Joshua C

2013-01-01

An accurate computable representation of food and drug allergy is essential for safe healthcare. Our goal was to develop a high-performance, easily maintained algorithm to identify medication and food allergies and sensitivities from unstructured allergy entries in electronic health record (EHR) systems. An algorithm was developed in Transact-SQL to identify ingredients to which patients had allergies in a perioperative information management system. The algorithm used RxNorm and natural language processing techniques developed on a training set of 24 599 entries from 9445 records. Accuracy, specificity, precision, recall, and F-measure were determined for the training dataset and repeated for the testing dataset (24 857 entries from 9430 records). Accuracy, precision, recall, and F-measure for medication allergy matches were all above 98% in the training dataset and above 97% in the testing dataset for all allergy entries. Corresponding values for food allergy matches were above 97% and above 93%, respectively. Specificities of the algorithm were 90.3% and 85.0% for drug matches and 100% and 88.9% for food matches in the training and testing datasets, respectively. The algorithm had high performance for identification of medication and food allergies. Maintenance is practical, as updates are managed through upload of new RxNorm versions and additions to companion database tables. However, direct entry of codified allergy information by providers (through autocompleters or drop lists) is still preferred to post-hoc encoding of the data. Data tables used in the algorithm are available for download. A high performing, easily maintained algorithm can successfully identify medication and food allergies from free text entries in EHR systems.

21 CFR 1404.310 - What must I do if a Federal agency excludes a person with whom I am already doing business in a...

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false What must I do if a Federal agency excludes a person with whom I am already doing business in a covered transaction? 1404.310 Section 1404.310 Food and...) Responsibilities of Participants Regarding Transactions Doing Business with Other Persons § 1404.310 What must I do...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

The 2015 US Food and Drug Administration Pregnancy and Lactation Labeling Rule.

Science.gov (United States)

Brucker, Mary C; King, Tekoa L

2017-05-01

As of 2015, the US Food and Drug Administration (FDA) discontinued the pregnancy risk categories (ABCDX) that had been used to denote the putative safety of drugs for use among pregnant women. The ABCDX system has been replaced by the FDA Pregnancy and Lactation Labeling Rule (PLLR) that requires narrative text to describe risk information, clinical considerations, and background data for the drug. The new rule includes 3 overarching categories: 1) pregnancy, which includes labor and birth; 2) lactation; and 3) females and males of reproductive potential. This article reviews the key components of the PLLR and clinical implications, and provides resources for clinicians who prescribe drugs for women of reproductive age. © 2017 by the American College of Nurse-Midwives.

21 CFR 1310.21 - Sale by Federal departments or agencies of chemicals which could be used to manufacture...

Science.gov (United States)

2010-04-01

... chemicals which could be used to manufacture controlled substances. 1310.21 Section 1310.21 Food and Drugs... manufacture controlled substances. (a) A Federal department or agency may not sell from the stocks of the... Administration, could be used in the manufacture of a controlled substance, unless the Administrator certifies in...

The role of the central ghrelin system in reward from food and chemical drugs.

Science.gov (United States)

Dickson, Suzanne L; Egecioglu, Emil; Landgren, Sara; Skibicka, Karolina P; Engel, Jörgen A; Jerlhag, Elisabet

2011-06-20

Here we review recent advances that identify a role for the central ghrelin signalling system in reward from both natural rewards (such as food) and artificial rewards (that include alcohol and drugs of abuse). Whereas ghrelin emerged as a stomach-derived hormone involved in energy balance, hunger and meal initiation via hypothalamic circuits, it now seems clear that it also has a role in motivated reward-driven behaviours via activation of the so-called "cholinergic-dopaminergic reward link". This reward link comprises a dopamine projection from the ventral tegmental area (VTA) to the nucleus accumbens together with a cholinergic input, arising primarily from the laterodorsal tegmental area. Ghrelin administration into the VTA or LDTg activates the "cholinergic-dopaminergic" reward link, suggesting that ghrelin may increase the incentive value of motivated behaviours such as reward-seeking behaviour ("wanting" or "incentive motivation"). Further, direct injection of ghrelin into the brain ventricles or into the VTA increases the consumption of rewarding foods as well as alcohol in mice and rats. Studies in rodents show beneficial effects of ghrelin receptor (GHS-R1A) antagonists to suppress the intake of palatable food, to reduce preference for caloric foods, to suppress food reward and motivated behaviour for food. They have also been shown to reduce alcohol consumption, suppress reward induced by alcohol, cocaine and amphetamine. Furthermore, variations in the GHS-R1A and pro-ghrelin genes have been associated with high alcohol consumption, smoking and increased weight gain in alcohol dependent individuals as well as with bulimia nervosa and obesity. Thus, the central ghrelin signalling system interfaces neurobiological circuits involved in reward from food as well as chemical drugs; agents that directly or indirectly suppress this system emerge as potential candidate drugs for suppressing problematic over-eating that leads to obesity as well as for the

Functional evaluation of healthcare products such as cosmetics, drugs, and foods

International Nuclear Information System (INIS)

Hatta, Ichiro

2008-01-01

The present paper surveys analytical methods recently employed in the field of healthcare products such as cosmetics, drugs, and foods by using Spring-8 facility which delivers high-intensity X-ray beams from electron cyclotron accelerator. These X-ray beams can be used to analyze atoms and their chemical state in human tissues such as skin, hair, whisker, teeth, and new developed products. Thus, a variety of products related with medical supplies, health food products, health maintenance, and preventive medicine concern this research group. Here, the results on colloidal states, such as lipid-molecule aggregates and lamellar structure type, generally present in cosmetic products and food substances, are focused and reported, specifically focusing on hair cuticle and honey cell layer of the skin regarding to cosmetic and pharmaceutical products. (S. Ohno)

78 FR 41803 - Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug...

Science.gov (United States)

2013-07-11

... Administration Safety and Innovation Act (FDASIA) Section 1138, enacted July 9, 2012, and posted on the FDA Web... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0757] Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug Administration...

Risk of Clinically Relevant Pharmacokinetic-based Drug-drug Interactions with Drugs Approved by the U.S. Food and Drug Administration Between 2013 and 2016.

Science.gov (United States)

Yu, Jingjing; Zhou, Zhu; Tay-Sontheimer, Jessica; Levy, Rene H; Ragueneau-Majlessi, Isabelle

2018-03-23

A total of 103 drugs (including 14 combination drugs) were approved by the U.S. Food and Drug Administration from 2013 to 2016. Pharmacokinetic-based drug interaction profiles were analyzed using the University of Washington Drug Interaction Database and the clinical relevance of these observations was characterized based on information from New Drug Application reviews. CYP3A was identified as a major contributor to clinical drug-drug interactions (DDIs), involved in approximately 2/3 of all interactions. Transporters (alone or with enzymes) were found to participate in about half of all interactions, although most of these were weak-to-moderate interactions. When considered as victims, eight new molecular entities (NMEs; cobimetinib, ibrutnib, isavuconazole, ivabradine, naloxegol, paritaprevir, simeprevir, and venetoclax) were identified as sensitive substrates of CYP3A, two NMEs (pirfenidone and tasimelteon) were sensitive substrates of CYP1A2, one NME (dasabuvir) was a sensitive substrate of CYP2C8, one NME (eliglustat) was a sensitive substrate of CYP2D6, and one NME (grazoprevir) was a sensitive substrate of OATP1B1/3 (with changes in exposure greater than 5-fold when co-administered with a strong inhibitor). Interestingly, approximately 75% of identified CYP3A substrates were also substrates of P-gp. As perpetrators, most clinical DDIs involved weak-to-moderate inhibition or induction, with only two drugs (Viekira Pak and idelalisib) showing strong inhibition of CYP3A, and one NME (lumacaftor) considered as a strong CYP3A inducer. Among drugs with large changes in exposure (≥ 5-fold), whether as victim or perpetrator, the most represented therapeutic classes were antivirals and oncology drugs, suggesting a significant risk of clinical DDIs in these patient populations. The American Society for Pharmacology and Experimental Therapeutics.

Needs of food irradiation and its commercialization

International Nuclear Information System (INIS)

Welt, M.A.

1984-01-01

On July 5, 1983, the United States Food and Drug Administration filed a notice in the Federal Register approving the use of Cobalt 60 or Cesium 137 gamma radiation to reduce or control microbial contamination in spices, onion powder and garlic powder. The approval was the first in nineteen years issued by the FDA and appears to set the stage for increased regulatory approvals in the area of radiation preservation of foods. On July 8, 1983, the Codex Alimentarius Commission approved an international standard for irradiated foods. The standard had previously been introduced by experts in the World Health Organization and the Food and Agriculture Organization. The ability of properly applied ionizing energy to inhibit sprouting, to eliminate the need for toxic chemical fumigants for insect disinfestation purposes, to extend refrigerated shelf life of many food products, to eliminate parasites and pathogens from our food chain and to preserve precooked packaged food products for indefinite storage without freezing or refrigeration, dictates the timeliness of food irradiation technology. (author)

Rethinking the Food and Drug Administration's 2013 guidance on developing drugs for early-stage Alzheimer's disease.

Science.gov (United States)

Schneider, Lon S

2014-03-01

The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Indonesian jellyfish as potential for raw materials of food and drug

Science.gov (United States)

Yusuf, S.; Fahmid, I. M.; Abdullah, N.; Zulhaeriah

2018-05-01

Jellyfish used to be considered as a pest of fish and a nuisance to fishing operations. Yet, forty years ago this jellyfish was found to be materials of food, medicine and cosmetics and the utilization of jellyfish is now familiar in Indonesia after being imported by China and Japan industry. This study aims to determine the potential development of jellyfish commodities as food and drugs from Indonesia with the target to improve the welfare of fishermen. This research used methods of rapid observation, limited interview, processing with immersion experiment and desiccation. In addition, various literatures were also used to enrich the knowledge about jellyfish business. Observation showed that the appearance of jellyfish in Indonesian waters varies based on the fertility of the waters affected by oceanographic conditions. Jellyfish contains low calorie and fat content, high protein and minerals as well as total collagen. Thus, jellyfish is a nutritious food source to be developed into food supplements, nutricosmetics and functional foods. Due to its large size, the jellyfish from Bunyu Island is more viable than jellyfish from Suppa Pinrang to be exported as raw material. Therefore, the manufacture of food and medicines from jellyfish materials is possible to be done in Indonesia.

Addicted to palatable foods: comparing the neurobiology of Bulimia Nervosa to that of drug addiction.

Science.gov (United States)

Hadad, Natalie A; Knackstedt, Lori A

2014-05-01

Bulimia nervosa (BN) is highly comorbid with substance abuse and shares common phenotypic and genetic predispositions with drug addiction. Although treatments for the two disorders are similar, controversy remains about whether BN should be classified as addiction. Here, we review the animal and human literature with the goal of assessing whether BN and drug addiction share a common neurobiology. Similar neurobiological features are present following administration of drugs and bingeing on palatable food, especially sugar. Specifically, both disorders involve increases in extracellular dopamine (DA), D1 binding, D3 messenger RNA (mRNA), and ΔFosB in the nucleus accumbens (NAc). Animal models of BN reveal increases in ventral tegmental area (VTA) DA and enzymes involved in DA synthesis that resemble changes observed after exposure to addictive drugs. Additionally, alterations in the expression of glutamate receptors and prefrontal cortex activity present in human BN or following sugar bingeing in animals are comparable to the effects of addictive drugs. The two disorders differ in regards to alterations in NAc D2 binding, VTA DAT mRNA expression, and the efficacy of drugs targeting glutamate to treat these disorders. Although additional empirical studies are necessary, the synthesis of the two bodies of research presented here suggests that BN shares many neurobiological features with drug addiction. While few Food and Drug Administration-approved options currently exist for the treatment of drug addiction, pharmacotherapies developed in the future, which target the glutamate, DA, and opioid systems, may be beneficial for the treatment of both BN and drug addiction.

75 FR 32482 - Investigational New Drug Applications; Co-development of Investigational Drugs

Science.gov (United States)

2010-06-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0247] Investigational New Drug Applications; Co-development of Investigational Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. SUMMARY: The Food and Drug...

ANTIMICROBIAL DRUG RESISTANCE IN STRAINS OF Escherichia coli ISOLATED FROM FOOD SOURCES

Directory of Open Access Journals (Sweden)

Mohammed Uddin Rasheed

2014-07-01

Full Text Available A variety of foods and environmental sources harbor bacteria that are resistant to one or more antimicrobial drugs used in medicine and agriculture. Antibiotic resistance in Escherichia coli is of particular concern because it is the most common Gram-negative pathogen in humans. Hence this study was conducted to determine the antibiotic sensitivity pattern of E. coli isolated from different types of food items collected randomly from twelve localities of Hyderabad, India. A total of 150 samples comprising; vegetable salad, raw egg-surface, raw chicken, unpasteurized milk, and raw meat were processed microbiologically to isolate E. coli and to study their antibiotic susceptibility pattern by the Kirby-Bauer method. The highest percentages of drug resistance in isolates of E. coli were detected from raw chicken (23.3% followed by vegetable salad (20%, raw meat (13.3%, raw egg-surface (10% and unpasteurized milk (6.7%. The overall incidence of drug resistant E. coli was 14.7%. A total of six (4% Extended Spectrum β-Lactamase (ESBL producers were detected, two each from vegetable salads and raw chicken, and one each from raw egg-surface and raw meat. Multidrug resistant strains of E. coli are a matter of concern as resistance genes are easily transferable to other strains. Pathogen cycling through food is very common and might pose a potential health risk to the consumer. Therefore, in order to avoid this, good hygienic practices are necessary in the abattoirs to prevent contamination of cattle and poultry products with intestinal content as well as forbidding the use of untreated sewage in irrigating vegetables.

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date. Final rule; delay of effective date.

Science.gov (United States)

2004-02-23

The Food and Drug Administration (FDA) is further delaying, until December 1, 2006, the effective date of certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). In the Federal Register of May 3, 2000 (65 FR 25639), the agency delayed until October 1, 2001, the effective date of certain requirements in the final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. The agency further delayed the effective date of these requirements in three subsequent Federal Register notices. Most recently, in the Federal Register of January 31, 2003 (68 FR 4912), FDA delayed the effective date until April 1, 2004. This action further delays the effective date of these requirements until December 1, 2006. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The agency is taking this action to address concerns about the requirements in the final rule raised by affected parties. As explained in the SUPPLEMENTARY INFORMATION section, FDA is working with stakeholders through its counterfeit drug initiative to facilitate widespread, voluntary adoption of track and trace technologies that will generate a de facto electronic pedigree, including prior transaction history back to the original manufacturer, as a routine course of business. If this technology is widely adopted, it is expected to help fulfill the pedigree requirements of the PDMA and obviate or resolve many of the concerns that have been raised with respect to the final rule by ensuring that an electronic pedigree travels with a drug product at all times. Therefore, it is necessary to delay the effective date of Sec

Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.

Science.gov (United States)

Pelletier, David L

2005-05-01

The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.

Effect of food on early drug exposure from extended-release stimulants: results from the Concerta, Adderall XR Food Evaluation (CAFE) Study.

Science.gov (United States)

Auiler, J F; Liu, K; Lynch, J M; Gelotte, C K

2002-01-01

Stimulant therapy is the mainstay of treatment for children, adolescents and adults with attention-deficit/hyperactivity disorder (ADHD). Once-daily, extended-release oral formulations offer long acting control of symptoms by modifying drug delivery and absorption. In particular, consistency in early drug exposure is important for symptom control during school or work hours. Because these once-daily formulations are usually taken in the morning, the timing of the doses with breakfast is important. This study compared the effect of a high-fat breakfast on early drug exposure from a morning dose of two extended-release stimulant formulations: the osmotic-controlled OROS tablet of methylphenidate HCI (CONCERTA) and the capsule containing extended-release beads of mixed amphetamine salts (ADDERALL XR). The study had a single-dose, open-label, randomised, four-treatment, crossover design in which healthy subjects received either 36 mg CONCERTA or 20 mg ADDERALL XR in the morning after an overnight fast or a high-fat breakfast. Serial blood samples were collected over 28h to determine plasma concentrations of methylphenidate and amphetamine. The food effect on early drug exposure and the pharmacokinetic profiles up to 8 h after dosing of the two extended-release stimulants were directly compared using partial area (AUC(p4h), AUC(p6h) and AUC(p8h)) fed/fasted ratios. Amphetamine concentrations were markedly lower when the subjects had eaten breakfast, resulting in lower early drug exposures (p food, for patients with ADHD.

Pluripotent stem cells in translation: a Food and Drug Administration-National Institutes of Health collaboration.

Science.gov (United States)

Kleitman, Naomi; Rao, Mahendra S; Owens, David F

2013-07-01

Recently, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health, and the stem cell research community have collaborated on a series of workshops that address moving pluripotent stem cell therapies into the clinic. The first two workshops in the series focused on preclinical science, and a third, future workshop will focus on clinical trials. This summary addresses major points from both of the recent preclinically focused meetings. When entering into a therapeutics developmental program based on pluripotent cells, investigators must make decisions at the very early stages that will have major ramifications during later phases of development. Presentations and discussions from both invited participants and FDA staff described the need to characterize and document the quality, variability, and suitability of the cells and commercial reagents used at every translational stage. This requires consideration of future regulatory requirements, ranging from donor eligibility of the original source material to the late-stage manufacturing protocols. Federal, industrial, and academic participants agreed that planning backward is the best way to anticipate what evidence will be needed to justify human testing of novel therapeutics and to eliminate wasted efforts.

What does a study of nonsteroidal anti-inflammatory drug sales statistics give the Russian Federation?

Directory of Open Access Journals (Sweden)

Viktoriya Georgievna Barskova

2011-01-01

Full Text Available The paper analyzes the data obtained by Pharmexpert on the sales of nonsteroidal anti-inflammatory drugs in the Russian Federation. Ibuprofen, ketorolac, diclofenac, and nimesulide are sales leaders. Possible reasons for the popularity of a number of medications and whether it is expedient to use intramuscular formulations are considered. The WHO data on indi-cations for and contraindications to the use of injectable dosage form are given.

Food irradiation - after 30 years, where do we stand: A government perspective

International Nuclear Information System (INIS)

Young, A.L.

1996-01-01

The use of irradiation to improve the safety, protect the nutritional benefits, and preserve the quality of fresh and processed foods is a well established and proven technology. Over the past 30 years, the United States Government has invested in the science of confirm safety and in the technology to show application. The United States Department of Agriculture and the Food and Drug Administration have approved sources of ionizing radiation for the treatment of foods, and their application to most meats, fruits, vegetables, and spices. Despite the value of this technology to the food industry and to the health and welfare of the public, only minimal application of this technology occurs. This underscorces the importantce of increasing the public's understanding of radiation risks relative to other hazards. Accordingly, the Committee on Interagency Radiation Research and Policy Coordination of the Executive Office of the President has made recommendations for the creation of a centralized National Radiation Information Center that would work closely with Federal departments and agencies in responding to public queries about radiation issues and Federal programs. (orig.)

77 FR 35837 - Conditionally Approved New Animal Drugs for Minor Use and Minor Species; Masitinib

Science.gov (United States)

2012-06-15

.... The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs. DATES... in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids. In accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Minor Use and...

Food irradiation

International Nuclear Information System (INIS)

Soothill, R.

1987-01-01

The issue of food irradiation has become important in Australia and overseas. This article discusses the results of the Australian Consumers' Association's (ACA) Inquiry into food irradiation, commissioned by the Federal Government. Issues discussed include: what is food irradiation; why irradiate food; how much food is consumer rights; and national regulations

76 FR 78931 - Food and Drug Administration Rare Disease Patient Advocacy Day; Notice of Meeting

Science.gov (United States)

2011-12-20

... Administration, HHS. ACTION: Notice. The Food and Drug Administration's (FDA) Office of Orphan Products... educate the rare disease community on the FDA regulatory processes. This educational meeting will consist...

[Effect of Food Thickeners on the Disintegration, Dissolution, and Drug Activity of Rapid Oral-disintegrating Tablets].

Science.gov (United States)

Tomita, Takashi; Kohda, Yukinao; Kudo, Kenzo

2018-01-01

　For patients with dysphagia in medical facilities and nursing homes, food thickeners are routinely used to aid the ingestion of medicines such as tablets. However, some types of thickeners affect the disintegration and dissolution of tablets, such as rapidly-disintegrating magnesium oxide tablets and donepezil hydrochloride orally disintegrating tablets. Additionally, delayed disintegration and dissolution of tablets affect a drug's efficacy. As an example, with Voglibose orally disintegrating tablets, marked differences are observed in changes in glucose levels during glucose tolerance testing. When using food thickeners to aid tablet ingestion, it is therefore necessary to select a product that has little effect on drug disintegration, dissolution, and activity.

Residues in food derived from animals

International Nuclear Information System (INIS)

Grossklaus, D.

1989-01-01

The first chapter presents a survey of fundamentals and methods of the detection and analysis of residues in food derived from animals, also referring to the resulting health hazards to man, and to the relevant legal provisions. The subsequent chapters have been written by experts of the Federal Health Office, each dealing with particular types of residues such as those of veterinary drugs, additives to animal feeds, pesticide residues, and with environmental pollutants and the contamination of animal products with radionuclides. (MG) With 35 figs., 61 tabs [de

77 FR 50113 - ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons...

Science.gov (United States)

2012-08-20

... disability, please contact Cindy Garris, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm... that the implant must withstand and perform. Moreover, the optimal preclinical/bench testing paradigm...

76 FR 12563 - Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime

Science.gov (United States)

2011-03-08

... spinosad and milbemycin oxime in dogs for the treatment and prevention of flea infestations and for the... and milbemycin oxime) Chewable Tablets in dogs for the treatment and prevention of flea infestations... Friday. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2...

78 FR 26375 - Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship...

Science.gov (United States)

2013-05-06

...] Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship... Society of Pharmaceutical Engineering (ISPE), is announcing a conference entitled ``Redefining the `C' in CGMP: Creating, Implementing and Sustaining a Culture of Quality'' Pharmaceutical Quality System (ICH...

Chocolate: food or drug?

Science.gov (United States)

Bruinsma, K; Taren, D L

1999-10-01

Although addictive behavior is generally associated with drug and alcohol abuse or compulsive sexual activity, chocolate may evoke similar psychopharmacologic and behavioral reactions in susceptible persons. A review of the literature on chocolate cravings indicates that the hedonic appeal of chocolate (fat, sugar, texture, and aroma) is likely to be a predominant factor in such cravings. Other characteristics of chocolate, however, may be equally as important contributors to the phenomena of chocolate cravings. Chocolate may be used by some as a form of self-medication for dietary deficiencies (eg, magnesium) or to balance low levels of neurotransmitters involved in the regulation of mood, food intake, and compulsive behaviors (eg, serotonin and dopamine). Chocolate cravings are often episodic and fluctuate with hormonal changes just before and during the menses, which suggests a hormonal link and confirms the assumed gender-specific nature of chocolate cravings. Chocolate contains several biologically active constituents (methylxanthines, biogenic amines, and cannabinoid-like fatty acids), all of which potentially cause abnormal behaviors and psychological sensations that parallel those of other addictive substances. Most likely, a combination of chocolate's sensory characteristics, nutrient composition, and psychoactive ingredients, compounded with monthly hormonal fluctuations and mood swings among women, will ultimately form the model of chocolate cravings. Dietetics professionals must be aware that chocolate cravings are real. The psychopharmacologic and chemosensory effects of chocolate must be considered when formulating recommendations for overall healthful eating and for treatment of nutritionally related health issues.

Flatulence awareness among the masses and its affiity with daily foods along with anti-ulcerant drugs in Bangladesh

Directory of Open Access Journals (Sweden)

Moynul Hasan

2016-05-01

Full Text Available Objective: To specify the current status of consciousness about flatulence and identify the effect of food and medicine used in gastritis status on it. Methods: It was an in-depth interview based qualitative analysis. A series of questions were asked to 300 individuals from 110 families about their food habit, knowledge about flatulence, possible cause, self-medication and course-completion of drug. Results: About 99.99% of respondents took rice, fish and vegetables as their main course, and 90% had self-medication, but only 2%–3% maintained the proper dose of drug. About 30% took antacid and the rest was the type of proton pump inhibitor, anti-ulcerant drugs. Conclusions: This survey reveals that a significant percentage of people are suffering from flatulence. Proper guidelines for taking medication and the avoidance of oily food and fiber rich diet may reduce its frequencies. Therefore, it is urgent to originate public cognizance and education on the cause and remedied issues through regular crusade.

The US Opioid Crisis: Current Federal and State Legal Issues.

Science.gov (United States)

Soelberg, Cobin D; Brown, Raeford E; Du Vivier, Derick; Meyer, John E; Ramachandran, Banu K

2017-11-01

The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing. Other federal agencies involved with the federal regulatory effort include the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and the Department of Justice. Each federal agency has a unique role in helping to stem the burgeoning opioid misuse epidemic. The DEA, working with the Department of Justice, has enforcement power to prosecute pill mills and physicians for illegal prescribing. The DEA could also implement use of prescription drug monitoring programs (PDMPs), currently administered at the state level, and use of electronic prescribing for schedule II and III medications. The FDA has authority to approve new and safer formulations of immediate- and long-acting opioid medications. More importantly, the FDA can also ask pharmaceutical companies to cease manufacturing a drug. Additionally, state agencies play a critical role in reducing overdose deaths, protecting the public safety, and promoting the medically appropriate treatment of pain. One of the states' primary roles is the regulation of practice of medicine and the insurance industry within their borders. Utilizing this authority, states can both educate physicians about the dangers of opioids and make physician licensure dependent on registering and using PDMPs when prescribing controlled substances. Almost every state has implemented a PDMP to some degree; however, in addition to mandating their use, increased interstate

76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Science.gov (United States)

2011-12-20

..., electronic record requirements, and investigator initiated research. Topics for discussion include the...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Clinical Research Associates (SoCRA), is announcing a public workshop. The public workshop on FDA's...

Proposed Food and Drug Administration protective action guides for human food and animal feed: methods and implementation

International Nuclear Information System (INIS)

Schmidt, G.D.; Shleien, B.; Chiacchierini, R.P.

1978-01-01

The Food and Drug Administration's proposed recommendations to State and local agencies provide guidance on appropriate planning actions necessary for evaluating and preventing radioactive contamination of foods and animal feeds and the control and use of such products should they become contaminated. This presentation will cover the recommendations on implementation of the Preventive and Emergency PAG's. These recommendations include (1) the use of 'Dietary Factors' to obtain PAG's for specific food items from the general guidance, (2) procedures to be used for radionuclide mixtures and other radionuclides, (3) field and laboratory methods for the measurement of the level of contamination in the event of an incident and, (4) protective actions to be implemented by State and local agencies to limit the radiation dose to the public. Specific protective actions which should be considered for implementation when the projected dose exceeds the Preventive PAG are given for application to pasture, milk, fruits and vegetables, and grains. At the Emergency PAG level, the protective action decision is whether condemnation or other disposition is appropriate. (author)

75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Science.gov (United States)

2010-03-25

... requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled ``FDA...

77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Science.gov (United States)

2012-02-15

..., electronic record requirements, and investigator initiated research. Topics for discussion include the...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial...

Development of Combination HIV Prevention Programs for People Who Inject Drugs through Government and Civil Society Collaboration in the Russian Federation

Directory of Open Access Journals (Sweden)

M. V. Volik

2012-01-01

Full Text Available Population Services International (PSI has worked collaboratively with several government institutions of the Russian Federation to develop and implement a model program to access health services for individuals who are opioid dependent, including those with HIV infection. Through the development of partnership agreements between government organizations (GOs and non-government organizations (NGOs, a model of the continuum of care has been developed that identifies a Recommended Package of HIV Prevention Services for Injecting Drug Users (RPS-IDU. The implementation of the RPS-IDU in the Russian Federation offers a model for other countries with HIV epidemics associated with injection drug use. This paper will describe the model program and its implementation in one of the pilot program regions.

76 FR 19998 - Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program

Science.gov (United States)

2011-04-11

...: Linda C. Ulrich, Office of Orphan Products Development, Food and Drug Administration, 10903 New... projects through the development process, including product identification, prototype design, device...

Development of special medical foods and botanical drugs using HemoHIM for cancer patients during radiation therapy

International Nuclear Information System (INIS)

Jo, Sung Kee; Jung, U Hee; Park, Hae Ran

2010-02-01

In vivo evaluation on the reductive effects of HemoHIM on the side-effects of radiation and anticancer drug treatment. - Evaluation on the promoting effects of HemoHIM on the tumor growth inhibitory activities of radiation and anticancer drug(cisplatin) in tumor-bearing mice. - Evaluation of the reductive effects of HemoHIM on the immune suppressive side-effects of radiation and anticancer drug(cisplatin) in tumor-bearing mice. - Evaluation of reductive effects of HemoHIM on the self-renewal tissue(intestine) damage of radiation and anticancer drug(5-FU) in mice. · Assessment of toxicological safety of HemoHIM (GLP) and establishment of analytical methods for active/index components of HemoHIM - Assurance of toxicological safety in single-dose and 3 month repeat-dose toxicity test in rats - Establishment of analytical methods for active/index compounds and content analysis result in various production lots. · Production of Special Medical Food pilot products for cancer patients and development of dosage forms for the natural new drugs. - Establishment of optimal formulations including HemoHIM for the Special Medical Food - Production of Special Medical Food pilot products for clinical test, analysis of nutrients, and official declaration of food production - Establishment of production process of HemoHIM for natural drug and production of pilot products for toxicity tests - Development of drug dosage forms of HemoHIM (tablet, granule, capsule) · Clinical evaluation of HemoHIM on reduction of side-effects of radiation and chemotherapy in cancer patients - Subjects: breast cancer patients who completed surgical operation and chemotherapy, HemoHIM administration during and after the radiation therapy (HemoHIM group: 15, placebo group 13) - Administration period: 3 months from few days before RT commencement - Results - Improvement of immunological biomarkers (immune cell subpopulations, cytokine production) - Reduction of and enhanced recovery from radiation skin

Development of special medical foods and botanical drugs using HemoHIM for cancer patients during radiation therapy

Energy Technology Data Exchange (ETDEWEB)

Jo, Sung Kee; Jung, U Hee; Park, Hae Ran

2010-02-15

In vivo evaluation on the reductive effects of HemoHIM on the side-effects of radiation and anticancer drug treatment. - Evaluation on the promoting effects of HemoHIM on the tumor growth inhibitory activities of radiation and anticancer drug(cisplatin) in tumor-bearing mice. - Evaluation of the reductive effects of HemoHIM on the immune suppressive side-effects of radiation and anticancer drug(cisplatin) in tumor-bearing mice. - Evaluation of reductive effects of HemoHIM on the self-renewal tissue(intestine) damage of radiation and anticancer drug(5-FU) in mice. {center_dot} Assessment of toxicological safety of HemoHIM (GLP) and establishment of analytical methods for active/index components of HemoHIM - Assurance of toxicological safety in single-dose and 3 month repeat-dose toxicity test in rats - Establishment of analytical methods for active/index compounds and content analysis result in various production lots. {center_dot} Production of Special Medical Food pilot products for cancer patients and development of dosage forms for the natural new drugs. - Establishment of optimal formulations including HemoHIM for the Special Medical Food - Production of Special Medical Food pilot products for clinical test, analysis of nutrients, and official declaration of food production - Establishment of production process of HemoHIM for natural drug and production of pilot products for toxicity tests - Development of drug dosage forms of HemoHIM (tablet, granule, capsule) {center_dot} Clinical evaluation of HemoHIM on reduction of side-effects of radiation and chemotherapy in cancer patients - Subjects: breast cancer patients who completed surgical operation and chemotherapy, HemoHIM administration during and after the radiation therapy (HemoHIM group: 15, placebo group 13) - Administration period: 3 months from few days before RT commencement - Results - Improvement of immunological biomarkers (immune cell subpopulations, cytokine production) - Reduction of and enhanced

Advances in allergic skin disease, anaphylaxis, and hypersensitivity reactions to foods, drugs, and insects in 2011.

Science.gov (United States)

Sicherer, Scott H; Leung, Donald Y M

2012-01-01

This review highlights some of the research advances in anaphylaxis; hypersensitivity reactions to foods, drugs, and insects; and allergic skin diseases that were reported in the Journal in 2011. Food allergy appears to be increasing in prevalence and carries a strong economic burden. Risk factors can include dietary ones, such as deficiency of vitamin D and timing of complementary foods, and genetic factors, such as filaggrin loss-of-function mutations. Novel mechanisms underlying food allergy include the role of invariant natural killer T cells and influences of dietary components, such as isoflavones. Among numerous preclinical and clinical treatment studies, promising observations include the efficacy of sublingual and oral immunotherapy, a Chinese herbal remedy showing promising in vitro results, the potential immunotherapeutic effects of having children ingest foods with baked-in milk if they tolerate it, and the use of anti-IgE with or without concomitant immunotherapy. Studies of allergic skin diseases, anaphylaxis, and hypersensitivity to drugs and insect venom are elucidating cellular mechanisms, improved diagnostics, and potential targets for future treatment. The role of skin barrier abnormalities, as well as the modulatory effects of the innate and adaptive immune responses, are major areas of investigation. Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

77 FR 8262 - Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

Science.gov (United States)

2012-02-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0081] Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Dealing food: female drug users' narratives about food in a prison place and implications for their health.

Science.gov (United States)

Smoyer, Amy B; Blankenship, Kim M

2014-05-01

Prison is a major "place" for drug users in the US, yet remarkably little is known about the lived experience of incarceration. More information about prison life is needed to improve health outcomes for incarcerated and formerly incarcerated people. Thirty (30) formerly incarcerated women were interviewed about prison food. All interviews were digitally recorded and transcribed. Qualitative data analysis software was used to code and organize the data using thematic analysis. As described in these participants' narratives, prison food systems contributed to the construction of boundaries that distinguished the prison place from places and life outside the institution's walls. Participants also described boundaries within the prison that resulted in a patchwork of interior places, each with their own unique structure, meaning, and food system. These places, constructed by physical location, movement, and power, or lack thereof, included various micro-geographies that further defined women's individual prison experience. The boundaries that separated these places were not fixed: Women shifted and diminished internal and external borders by resisting food policies and reproducing their outside lives inside. These findings call for public policy officials and prison administrators to reexamine the prison place in order to facilitate healthier eating behaviors and lay the groundwork for more positive communication between inmates and correctional staff and administration. More research is needed to measure how these types of changes to the prison food environment impact nutritional, mental health, substance abuse, and criminal justice outcomes. Copyright © 2013 Elsevier B.V. All rights reserved.

Dealing food: Female drug users’ narratives about food in a prison place and implications for their health

Science.gov (United States)

Smoyer, Amy B.; Blankenship, Kim M.

2015-01-01

Background Prison is a major “place” for drug users in the US, yet remarkably little is known about the lived experience of incarceration. More information about prison life is needed to improve health outcomes for incarcerated and formerly incarcerated people. Methods Thirty (30) formerly incarcerated women were interviewed about prison food. All interviews were digitally recorded and transcribed. Qualitative data analysis software was used to code and organize the data using thematic analysis. Results As described in these participants’ narratives, prison food systems contributed to the construction of boundaries that distinguished the prison place from places and life outside the institution's walls. Participants also described boundaries within the prison that resulted in a patchwork of interior places, each with their own unique structure, meaning, and food system. These places, constructed by physical location, movement, and power, or lack thereof, included various micro-geographies that further defined women's individual prison experience. The boundaries that separated these places were not fixed: Women shifted and diminished internal and external borders by resisting food policies and reproducing their outside lives inside. Conclusion These findings call for public policy officials and prison administrators to reexamine the prison place in order to facilitate healthier eating behaviors and lay the groundwork for more positive communication between inmates and correctional staff and administration. More research is needed to measure how these types of changes to the prison food environment impact nutritional, mental health, substance abuse, and criminal justice outcomes. PMID:24412007

Proposed food and drug administration protection action guides for human food and animal feed: Rationale and limits

International Nuclear Information System (INIS)

Shleien, B.; Schmidt, G.D.; Chiacchierini, R.P.

1978-01-01

The Food and Drug Administration is proposing Protective Action Guides (PAG's) to be used in the event that a radiological incident results in the radioactive contamination of human food and animal feed. PAG's are proposed for two levels of response: (1) PREVENTIVE PAG - establishes a level at which responsible officials should take protective action to prevent or reduce the concentration of radioactivity in food or animal feed. (2) EMERGENCY PAG - establishes a level at which responsible officials should isolate food containing radioactivity to prevent its introduction into commerce and determine whether condemnation or another disposition is appropriate. Derived response levels, which are defined as the concentration of radioactivity in food or animal feed corresponding to the above PAG's, are proposed for radionuclides of most significance. The presentation will discuss the supporting rationale as well as the numerical limits for the PAG's. This rationale is based on the process of risk assessment and cost-benefit and cost-effectiveness analysis. The risk assessment compares the risk of radiation exposure to the risk from prevalent hazards accepted by society and from variability of the natural radiation environment. The cost-benefit analysis is limited to protective actions efficacious in the reduction of iodine-131 dose to the thyroid via the milk pathway (condemnation and use of stored feed). In addition, the metabolic and agricultural transfer models that were used to calculate derived response levels will be described briefly. (author)

Proposed food and drug administration protection action guides for human food and animal feed: Rationale and limits

Energy Technology Data Exchange (ETDEWEB)

Shleien, B; Schmidt, G D; Chiacchierini, R P [Food and Drug Administration, Bureau of Radiological Health, Rockville, MD (United States)

1978-12-01

The Food and Drug Administration is proposing Protective Action Guides (PAG's) to be used in the event that a radiological incident results in the radioactive contamination of human food and animal feed. PAG's are proposed for two levels of response: (1) PREVENTIVE PAG - establishes a level at which responsible officials should take protective action to prevent or reduce the concentration of radioactivity in food or animal feed. (2) EMERGENCY PAG - establishes a level at which responsible officials should isolate food containing radioactivity to prevent its introduction into commerce and determine whether condemnation or another disposition is appropriate. Derived response levels, which are defined as the concentration of radioactivity in food or animal feed corresponding to the above PAG's, are proposed for radionuclides of most significance. The presentation will discuss the supporting rationale as well as the numerical limits for the PAG's. This rationale is based on the process of risk assessment and cost-benefit and cost-effectiveness analysis. The risk assessment compares the risk of radiation exposure to the risk from prevalent hazards accepted by society and from variability of the natural radiation environment. The cost-benefit analysis is limited to protective actions efficacious in the reduction of iodine-131 dose to the thyroid via the milk pathway (condemnation and use of stored feed). In addition, the metabolic and agricultural transfer models that were used to calculate derived response levels will be described briefly. (author)

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

Science.gov (United States)

Green, Dionna J; Liu, Xiaomei I; Hua, Tianyi; Burnham, Janelle M; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K; Burckart, Gilbert J; Zineh, Issam

2017-12-08

Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. In all, 112 efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75%, respectively. Eighty-eight trials (76.8%) employed at least one enrichment strategy; of these, 66.3% employed multiple enrichment strategies. The highest trial success rates were achieved when all three enrichment strategies (practical, predictive, and prognostic) were used together within a single trial (87.5%), while the lowest success rate was observed when no enrichment strategy was used (65.4%). The use of enrichment strategies in pediatric trials was found to be associated with trial and program success in our analysis. © 2017 American Society for Clinical Pharmacology and Therapeutics.

76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Science.gov (United States)

2011-08-17

... requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical...

Risk assessment principle for engineered nanotechnology in food and drug.

Science.gov (United States)

Hwang, Myungsil; Lee, Eun Ji; Kweon, Se Young; Park, Mi Sun; Jeong, Ji Yoon; Um, Jun Ho; Kim, Sun Ah; Han, Bum Suk; Lee, Kwang Ho; Yoon, Hae Jung

2012-06-01

While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.

Progress of food irradiation in the United States

International Nuclear Information System (INIS)

Derr, D.D.; Engeljohn, D.L.; Griffin, R.L.

1995-01-01

Irradiated foods have not yet made a significant impact in the United States marketplace. What progress has occurred to facilitate their commercialization? Irradiated produce has been sold in small quantities since 1992 and irradiated poultry was introduced in the marketplace in 1993. Federal inspection of irradiated commodities has settled into a regular routine. What must occur to further expand irradiated foods in the marketplace? Petitions to permit irradiation of red meats and seafood are being considered by the Food and Drug Administration (FDA) and a petition to permit the irradiation of shell eggs is being prepared for submission to FDA. In addition, the U.S. Department of Agriculture (USDA) has accelerated efforts to develop the policies and regulatory structure needed to facilitate the approval of new irradiation treatments for imported plant products regulated by quarantine. When will greater commercialization occur? More positive coverage to food irradiation in recent months by both the trade and popular press indicates a change in attitude towards irradiated foods by both consumers and the food industry. Finally, actual consumer response to available irradiated foods casts a favorable light on the potential for increased marketing of value-added irradiated foods. (Author)

Residues of carcinogenic animal drugs in food: difficulties in evaluation of human safety.

Science.gov (United States)

Somogyi, A

1979-01-01

The indisputable need to intensify animal production in order to provide an adequate food supply for the world population involves the use of substances that are highly potent pharmacologically and toxicologically. The history of regulatory action with regard to such additives is similar to that for other substances: first, no regulation; next, an over-reaction; and now decisions based on judicious evaluation of scientific facts. One factor that differentiates the chemicals used in animal production from other food additives is that both the parent compounds and their metabolites appear in edible products, posing problems both for the analytical detection and safety evaluation of such residues. It would be unrealistic to propose 'zero' tolerances for these additives, even if they are carcinogenic. The benefits gained from drugs that cure and prevent infections and parasitic diseases in food-producing animals, and the fact that analytical methods can now detect very small quantities make the presence of low levels of these substances in food unobjectionable.

75 FR 16346 - Ophthalmic and Topical Dosage Form New Animal Drugs; Orbifloxacin, Mometasone Furoate Monohydrate...

Science.gov (United States)

2010-04-01

... posaconazole for the treatment of otitis externa in dogs. DATES: This rule is effective April 1, 2010. FOR... posaconazole) Otic Suspension for the treatment of otitis externa in dogs associated with susceptible strains... statement is required. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C...

Inspector Perceptions of the Food and Drug Administration's Newest Recommended Food Facility Inspection Format: Training Matters.

Science.gov (United States)

Ma, Jing; Kim, Jooho; Almanza, Barbara

2017-06-01

The Food and Drug Administration publishes the Food Code to guide restaurant inspections. The most recent version proposes a three-tier system categorizing violations as priority, priority foundation, and core. This study used a scenario-based questionnaire to examine inspector perceptions and preferences for inspection formats. Results suggest that inspectors would be able to maintain consistent evaluations when changing to the three-tier system, although the classifying terms under the three-tier system were confusing. Additionally, inspectors were not very positive about the new system; they were concerned that the new system would not be easy to understand and use, inspections would take a longer time, it would not accurately reflect the amount of risk associated with violations, and it would not be easy for consumers and managers to understand and use. The results suggest the need for additional training for inspectors before adoption, especially on the rationale and benefits of changing to a three-tier system.

Toxicology in the use, misuse and abuse of food, drugs and chemicals

Energy Technology Data Exchange (ETDEWEB)

Chambers, P.L.; Chambers, C.M.; Gitter, S.

1983-01-01

The present proceedings containing 77 papers were presented at a meeting of the European Society of Toxicology held in Tel Aviv, March 21-24, 1982. The topics were: Effects of foreign substances on blood, drugs of abuse with special reference to marijuana and phencyclidine, toxic agents in food, xenobiotics, novel and new techniques in toxicology and miscellaneous toxic effects. Individual abstracts are prepared of 11 papers.

78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

Science.gov (United States)

2013-08-02

... send a check by a courier such as Federal Express or United Parcel Service, the courier may deliver the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0007... of the Treasury notifies FDA of payment. U.S. Bank and the United States Treasury are required to...

Distribution of blood derivatives by registered blood establishments that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; delay of applicability date. Final rule; delay of applicability date.

Science.gov (United States)

2006-11-13

The Food and Drug Administration (FDA) is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent Federal Register notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a "health care entity." In the Federal Register of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments. As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of Sec. 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes.

77 FR 47652 - Second Annual Food and Drug Administration Health Professional Organizations Conference

Science.gov (United States)

2012-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... include an update on the FDA Safety and Innovation Act (Pub. L. 112-144) and an overview of FDA's Network... liaison between FDA Centers and the public on matters that involve medical product safety and also acts as...

[Use of psychoactive drugs by health sciences undergraduate students at the Federal University in Amazonas, Brazil].

Science.gov (United States)

Lucas, Ana Cyra dos Santos; Parente, Rosana Cristina Pereira; Picanço, Neila Soares; Conceição, Denis Alvaci; Costa, Karen Regina Carim da; Magalhães, Igor Rafael dos Santos; Siqueira, João Cladirson Alves

2006-03-01

A survey was conducted with 521 undergraduate health sciences students from the Federal University in Amazonas, Manaus, Brazil. Lifetime alcohol consumption was reported by 87.7% students, as compared to 30.7% for tobacco, with the latter reported more frequently by males (39.7%). The most common illicit drugs were solvents (11.9%), marijuana (9.4%), amphetamines and anxiolytics (9.2% each), cocaine (2.1%), and hallucinogens (1.2%). The main reason for illicit drug use was curiosity. Lifetime use of anabolic steroids was reported by 2.1% of the students. Alcohol abuse in the previous 30 days was reported by 12.4% of the students. Events following drinking included: fights (4.7%), accidents (2.4%), classroom absenteeism (33.7%), and job absenteeism (11.8%). Another important finding was that 47.3% of students drove after drinking. Opinions on drug abuse and patterns agree with those from similar studies in other regions of Brazil.

Effects of food on a gastrically degraded drug: azithromycin fast-dissolving gelatin capsules and HPMC capsules.

Science.gov (United States)

Curatolo, William; Liu, Ping; Johnson, Barbara A; Hausberger, Angela; Quan, Ernest; Vendola, Thomas; Vatsaraj, Neha; Foulds, George; Vincent, John; Chandra, Richa

2011-07-01

Commercial azithromycin gelatin capsules (Zithromax®) are known to be bioequivalent to commercial azithromycin tablets (Zithromax®) when dosed in the fasted state. These capsules exhibit a reduced bioavailability when dosed in the fed state, while tablets do not. This gelatin capsule negative food effect was previously proposed to be due to slow and/or delayed capsule disintegration in the fed stomach, resulting in extended exposure of the drug to gastric acid, leading to degradation to des-cladinose-azithromycin (DCA). Azithromycin gelatin capsules were formulated with "superdisintegrants" to provide fast-dissolving capsules, and HPMC capsule shells were substituted for gelatin capsule shells, in an effort to eliminate the food effect. Healthy volunteers were dosed with these dosage forms under fasted and fed conditions; pharmacokinetics were evaluated. DCA pharmacokinetics were also evaluated for the HPMC capsule subjects. In vitro disintegration of azithromycin HPMC capsules in media containing food was evaluated and compared with commercial tablets and commercial gelatin capsules. When the two fast-dissolving capsule formulations were dosed to fed subjects, the azithromycin AUC was 38.9% and 52.1% lower than after fasted-state dosing. When HPMC capsules were dosed to fed subjects, the azithromycin AUC was 65.5% lower than after fasted-state dosing. For HPMC capsules, the absolute fasting-state to fed-state decrease in azithromycin AUC (on a molar basis) was similar to the increase in DCA AUC. In vitro capsule disintegration studies revealed extended disintegration times for commercial azithromycin gelatin capsules and HPMC capsules in media containing the liquid foods milk and Ensure®. Interaction of azithromycin gelatin and HPMC capsules with food results in slowed disintegration in vitro and decreased bioavailability in vivo. Concurrent measurement of serum azithromycin and the acid-degradation product DCA demonstrates that the loss of azithromycin

The analysis of drug consumption, drug trafficking and the fight against drug trafficking at the present day

Directory of Open Access Journals (Sweden)

Borisenko M.V.

2017-04-01

Full Text Available the article discusses the current drug situation in Russia, Siberian Federal District and Novosibirsk Region relating to drug consumption and drug trafficking and the main reasons of deaths of drug-dependent people.

Evaluation of the use of Göttingen minipigs to predict food effects on the oral absorption of drugs in humans

DEFF Research Database (Denmark)

Christiansen, Martin Lau; Müllertz, Anette; Garmer, Mats

2015-01-01

This study investigated the oral absorption of drugs in minipigs to predict food effects in man. The protocol was based on a previously described model in dogs and further investigated the food source (i.e., US FDA breakfast or a nutritional drink) and food quantities. Two poorly soluble compounds...

21 CFR 201.105 - Veterinary drugs.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Veterinary drugs. 201.105 Section 201.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Exemptions From Adequate Directions for Use § 201.105 Veterinary drugs. A drug subject to the...

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

Science.gov (United States)

Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

2013-01-22

The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5�

77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

Science.gov (United States)

2012-07-03

...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...

76 FR 45811 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

Science.gov (United States)

2011-08-01

... additional fees. If you prefer to send a check by a courier such as Federal Express (FEDEX) or United Parcel Service (UPS), the courier may deliver the check and printed copy of the cover sheet to: U.S. Bank, Attn... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0548...

78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

Science.gov (United States)

2013-02-26

... marketing applications, (2) what is meant by ``due diligence'' in obtaining financial disclosures from...: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

21 CFR 101.18 - Misbranding of food.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Misbranding of food. 101.18 Section 101.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.18 Misbranding of food. (a) Among...

Food insecurity is associated with HIV, sexually transmitted infections and drug use among men in the United States

Science.gov (United States)

PALAR, Kartika; LARAIA, Barbara; TSAI, Alexander C.; JOHNSON, Mallory; WEISER, Sheri D.

2016-01-01

Objective To examine the population-level association between food insecurity, HIV risk factors, and HIV serostatus among men, the group representing the majority of HIV diagnoses in the United States (US). Design Cross-sectional secondary data analysis using the National Health and Nutrition Examination Survey (NHANES) 1999-2012, a nationally representative survey of the civilian non-institutionalized US population. Methods Logistic regression with design weights and complex survey commands was used to estimate nationally-representative associations between food insecurity and HIV serostatus (primary outcome), herpes simplex virus 2 (HSV-2), self-reported STIs, and past-year illicit drug use among men, adjusting for potential confounders. Food security was measured using the 18-item Household Food Security Survey. Results We analyzed data for 9150 men representing 61 million individuals in the US. Unadjusted HIV prevalence was 1.5% among food insecure men, compared to 0.4% among food secure men (pinsecure men had over 2 times higher odds of HIV seropositivity compared to food secure men (adjusted odds ratio (AOR)=2.10; 95% CI 1.01 - 4.37; pinsecurity was associated with higher odds of HSV-2 seropositivity (AOR=1.28; 95% CI 1.04 - 1.57; pinsecurity is associated with prevalent HIV, STIs and illicit drug use among men in the US. Further research is needed to establish whether and through what mechanisms improved food security may help prevent new HIV infections. PMID:26990632

To the Federal Trade Commission in the Matter of a Trade Regulation Rule on Over-the-Counter Drug Advertising.

Science.gov (United States)

Council on Children, Media, and Merchandising, Washington, DC.

This report supports amending the proposed Federal Trade Commission (FTC) Rule on Over-the Counter (OTC) Drug Advertising to insure better protection for children, illiterate populations, the deaf and the blind, from advertising on the air-waves. Several points are addressed: (1) the difficulties of combining the rule making schedules of the Food…

21 CFR 330.5 - Drug categories.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug categories. 330.5 Section 330.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN...) Stimulants. (r) Antitussives. (s) Allergy treatment products. (t) Cold remedies. (u) Antirheumatic products...

77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Science.gov (United States)

2012-08-16

... investigator initiated research. Topics for discussion include the following: (1) What FDA Expects in a...] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The...

76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

Science.gov (United States)

2011-07-01

...-mail: [email protected] . Grants Management Contact Gladys Melendez-Bohler, Office of..., MD 20857, Tele.: 301-827-7175; e-mail: Gladys[email protected] . For more information on...: Gladys Melendez-Bohler, Office of Acquisition and Grant Services (OAGS), Food and Drug Administration...

Food effects in paediatric medicines development for products Co-administered with food.

Science.gov (United States)

Batchelor, Hannah; Kaukonen, Ann Marie; Klein, Sandra; Davit, Barbara; Ju, Rob; Ternik, Robert; Heimbach, Tycho; Lin, Wen; Wang, Jian; Storey, David

2018-02-05

A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability. However the impact of this co-administered food on the absorption and subsequent pharmacokinetic profile of the drug is unknown. Existing information on food effects is limited to standard protocols used to evaluate the impact of a high fat meal in an adult population using the adult medication. In the absence of a substantial body of data, there are no specific guidelines available during development of paediatric products relating to low volumes of potentially low calorie food. This paper brings together expertise to consider how the impact of co-administered food can be risk assessed during the development of a paediatric medicine. Two case studies were used to facilitate discussions and seek out commonalities in risk assessing paediatric products; these case studies used model drugs that differed in their solubility, a poorly soluble drug that demonstrated a positive food effect in adults and a highly soluble drug where a negative food effect was observed. For poorly soluble drugs risk assessments are centred upon understanding the impact of food on the in vivo solubility of the drug which requires knowledge of the composition of the food and the volumes present within the paediatric gastrointestinal tract. Further work is required to develop age appropriate in vitro and in silico models that are representative of paediatric populations. For soluble drugs it is more important to understand the mechanisms that may lead to a food effect, this may include interactions with transporters or the impact of the food composition on gastro-intestinal transit or even altered gastric motility. In silico models have the most promise for highly soluble drug products although it is essential that these models reflect the relevant mechanisms involved in potential food effects. The development of appropriate in vitro and in silico tools is

New strategies to improve food marketing to children.

Science.gov (United States)

Dietz, William H

2013-09-01

Federal efforts to address the impact of food marketing on children began more than thirty years ago, when the Federal Trade Commission sought comment on strategies to reduce young children's exposure to food advertising. The food, advertising, and television industries mounted a virulent response, and Congress withdrew the commission's authority to regulate unfair advertising to children. The same industries and Congress responded equally aggressively to the proposed nutrition criteria for food products marketed to children drafted by a working group of federal agencies in 2011. Although federal efforts over the past thirty years have led to modest improvements in food quality and marketing practices, commercial interests have consistently overridden the health concerns of children. Mobilization of parents as a political force to improve standards for food marketed to children, use of social media for counteradvertising, and the development of new technologies to decrease exposure to food advertisements could reduce the impact of food marketing to children.

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants.

Science.gov (United States)

Cornell, Erika; Kwa, Michael; Paller, Amy S; Xu, Shuai

2018-03-01

Despite their ubiquitous use and several recent health controversies involving cosmetics and personal care products for children, the Food and Drug Administration has little oversight of these products and relies on consumer-submitted adverse event reports. We assessed the recently released Center for Food Safety and Applied Nutrition's Adverse Event Reporting System database for adverse event reports submitted to the Food and Drug Administration for baby personal care products and to determine whether useful insights can be derived. We extracted the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System data file from 2004 to 2016 and examined the subset classified according to the Food and Drug Administration-designated product class as a baby product. Events were manually categorized into product type and symptom type to assess for trends. Only 166 total adverse events were reported to the Food and Drug Administration for baby products from 2004 to 2016. The majority of reports indicated rash or other skin reaction; 46% of reported events led to a health care visit. Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health. © 2018 Wiley Periodicals, Inc.

21 CFR 25.33 - Animal drugs.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Animal drugs. 25.33 Section 25.33 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.33 Animal drugs. The classes of actions listed in this section are...

Food intake and antiepileptic drugs: evidence for a role of GABA in circadian time keeping.

Science.gov (United States)

Rietveld, W J; van Schravendijk, K

1987-01-01

Long-term application of sodium-valproate was studied while recording food intake of rats. It was found that sodium valproate was able to decrease the period length of free-running circadian rhythmicity. After withdrawal of the drug, the period length returned to the predrug values.

78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

Science.gov (United States)

2013-09-25

... FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and...] Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability...) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is...

75 FR 79383 - Unapproved Animal Drugs

Science.gov (United States)

2010-12-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0528] Unapproved Animal Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA, the Agency) is soliciting comments from stakeholders on...

21 CFR 202.1 - Prescription-drug advertisements.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (e) * * * (6) * * * (ii) Represents or suggests that a...

Iodine Intake through Processed Food: Case Studies from Egypt, Indonesia, the Philippines, the Russian Federation and Ukraine, 2010-2015.

Science.gov (United States)

Knowles, Jacky; van der Haar, Frits; Shehata, Magdy; Gerasimov, Gregory; Bimo, Bimo; Cavenagh, Bettina; Maramag, Cherry C; Otico, Edward; Izwardy, Doddy; Spohrer, Rebecca; Garrett, Greg S

2017-07-26

The current performance indicator for universal salt iodisation (USI) is the percentage of households using adequately iodised salt. However, the proportion of dietary salt from household salt is decreasing with the increase in consumption of processed foods and condiments globally. This paper reports on case studies supported by the Global Alliance for Improved Nutrition (GAIN)-UNICEF USI Partnership Project to investigate processed food industry use of adequately iodised salt in contrasting national contexts. Studies were conducted in Egypt, Indonesia, the Philippines, the Russian Federation, and Ukraine. In all cases, the potential iodine intake from iodised salt in selected food products was modelled according to the formula: quantity of salt per unit of food product × minimum regulated iodine level of salt at production × average daily per capita consumption of the product. The percent of adult recommended nutrient intake for iodine potentially provided by the average daily intake of bread and frequently consumed foods and condiments was from 10% to 80% at the individual product level. The potential contribution to iodine intake from the use of iodised salt in the processed food industry is of growing significance. National USI strategies should encourage co-operative industry engagement and include regulatory monitoring of iodised salt use in the food industry in order to achieve optimal population iodine status.

21 CFR 170.10 - Food additives in standardized foods.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Food additives in standardized foods. 170.10... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES General Provisions § 170.10 Food additives... the Act, which proposes the inclusion of a food additive in such definition and standard of identity...

Largely overlapping neuronal substrates of reactivity to drug, gambling, food and sexual cues: A comprehensive meta-analysis.

Science.gov (United States)

Noori, Hamid R; Cosa Linan, Alejandro; Spanagel, Rainer

2016-09-01

Cue reactivity to natural and social rewards is essential for motivational behavior. However, cue reactivity to drug rewards can also elicit craving in addicted subjects. The degree to which drug and natural rewards share neural substrates is not known. The objective of this study is to conduct a comprehensive meta-analysis of neuroimaging studies on drug, gambling and natural stimuli (food and sex) to identify the common and distinct neural substrates of cue reactivity to drug and natural rewards. Neural cue reactivity studies were selected for the meta-analysis by means of activation likelihood estimations, followed by sensitivity and clustering analyses of averaged neuronal response patterns. Data from 176 studies (5573 individuals) suggests largely overlapping neural response patterns towards all tested reward modalities. Common cue reactivity to natural and drug rewards was expressed by bilateral neural responses within anterior cingulate gyrus, insula, caudate head, inferior frontal gyrus, middle frontal gyrus and cerebellum. However, drug cues also generated distinct activation patterns in medial frontal gyrus, middle temporal gyrus, posterior cingulate gyrus, caudate body and putamen. Natural (sexual) reward cues induced unique activation of the pulvinar in thalamus. Neural substrates of cue reactivity to alcohol, drugs of abuse, food, sex and gambling are largely overlapping and comprise a network that processes reward, emotional responses and habit formation. This suggests that cue-mediated craving involves mechanisms that are not exclusive for addictive disorders but rather resemble the intersection of information pathways for processing reward, emotional responses, non-declarative memory and obsessive-compulsive behavior. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.

Food Consumption, Diet & Health

DEFF Research Database (Denmark)

Daniel, Hannelore; Reisch, Lucia; Hamm, Ulrich

Bioeconomy plays a key role in the innovation policy of the German Federal Government. The Federal Ministry of Education and Research (BMBF) and the Federal Ministry of Food and Agriculture (BMEL) have over the years funded various branches of the bioeconomy sector, but with a particular focus...... the dialogue with consumers and all stakeholder and social groups from the outset. The food and nutrition sector seems particularly suitable for this as it is readily accessible. The foundation for a successful dialogue, however, is social science research which determines the needs, expectations and habits...

Irradiation: a safe measure for safer food

International Nuclear Information System (INIS)

Henkel, J.

1998-01-01

Beef is one of the U.S. food industry's hottest sellers--to the tune of 8 billion pounds a year, according to trade figures. Whether at a fast-food meal, a dinner on the town, or a backyard barbecue, beef is often front and center on America's tables. But in recent years, beef, especially ground beef, has shown a dark side: It can harbor the bacterium E. coli O157:H7, a pathogen that threatens the safety of the domestic food supply. If not properly prepared, beef tainted with E. coli O157:H7 can make people ill, and in rare instances, kill them. In 1993, E. coli O157:H7-contaminated hamburgers sold by a fast-food chain were linked to the deaths of four children and hundreds of illnesses in the Pacific Northwest. In 1997, the potential extent of E. coli O157:H7 contamination came to light when Arkansas-based Hudson Foods Inc. voluntarily recalled 25 million pounds of hamburger suspected of containing E. coli O157:H7. It was the largest recall of meat products in U.S. history. Nationally, E. coli O157:H7 causes about 20,000 illnesses and 500 deaths a year, according to the federal Centers for Disease Control and Prevention. Scientists have only known since 1982 that this form of E. coli causes human illness. To help combat this public health problem, the Food and Drug Administration, in December 1997, approved treating red meat products with a measured dose of radiation. This process, commonly called irradiation, has drawn praise from many food industry and health organizations because it can control E. coli O157:H7 and several other disease-causing microorganisms. As with other regulations governing meat and poultry products, irradiation will be authorized when the U.S. Department of Agriculture completes its implementing regulations. Though irradiation is the latest step toward curbing food-borne illness, the federal government also is implementing other measures, which include developing new technologies and expanding the use of current technologies

21 CFR 501.18 - Misbranding of animal food.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Misbranding of animal food. 501.18 Section 501.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.18 Misbranding of...

77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

Science.gov (United States)

2012-02-27

... proposed information collected is necessary for the proper performance of FDA's functions, including... the draft guidance for industry entitled: ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products'' (Absenteeism Draft Guidance) published in the Federal...

Hyperactivity--Drug Therapy/Food Additives/Allergies. A Selective Bibliography. Exceptional Child Bibliography Series No. 602.

Science.gov (United States)

ERIC Clearinghouse on Handicapped and Gifted Children, Reston, VA.

The annotated bibliography on Hyperactivity--Drug Therapy/Food Additives/Allergies contains approximately 65 abstracts and associated indexing information for documents or journal articles published from 1968 to 1975 and selected from the computer files of the Council for Exceptional Children's Information Services and the Education Resources…

Radionuclides in domestic and imported foods in the United States, 1987-1992

International Nuclear Information System (INIS)

Cunningham, W.C.; Anderson, D.L.; Baratta, E.J.

1994-01-01

Findings from the U.S. Food and Drug Administration's Radionuclides in Foods program are summarized for foods collected between October 1, 1986, and September 30, 1992. Concentrations of radionuclide activity in the Total Diet Study and reactor-survey foods were in Range I or low in Range II of the surveillance and control recommendations of the Federal Radiation Council; no control actions were suggested. Dietary intake of 90 Sr continued the general decline observed since 1961. Approximately 2600 test portions of imported foods were analyzed for contamination associated with the Chernobyl nuclear accident. Concentrations of radionuclide activity were below limits of detection for the vast majority of the imported food test portions but were above the levels of concern for 23 portions. Since 1986, the fraction of imported food test portions having measurable amounts of contamination has steadily declined, as have the average concentrations of radionuclide activity; however, contamination is still occasionally found. Continued monitoring of both domestic and imported foods is planned. 17 refs., 2 figs., 2 tabs

Determination of pesticides and veterinary drug residues in food by liquid chromatography-mass spectrometry: A review

Energy Technology Data Exchange (ETDEWEB)

Masiá, Ana [Food and Environmental Safety Research Group, Department of Preventive Medicine and Public Health, Food Science, Toxicology and Legal Medicine, University of Valencia, Valencia (Spain); Research Center on Desertification (CIDE, UV-CSIC-GV), Carretera Moncada-Náquera, Moncada (Spain); Suarez-Varela, Maria Morales; Llopis-Gonzalez, Agustin [Unit of Public Health, Hygiene and Environmental Health, Department of Preventive Medicine and Public Health, Food Science, Toxicology and Legal Medicine, University of Valencia, Valencia (Spain); CIBER Epidemiología y Salud Pública (CIBERESP), Madrid (Spain); Center for Advanced Research in Public Health (CSISP-FISABIO), Valencia (Spain); Picó, Yolanda, E-mail: Yolanda.Pico@uv.es [Food and Environmental Safety Research Group, Department of Preventive Medicine and Public Health, Food Science, Toxicology and Legal Medicine, University of Valencia, Valencia (Spain); Research Center on Desertification (CIDE, UV-CSIC-GV), Carretera Moncada-Náquera, Moncada (Spain); CIBER Epidemiología y Salud Pública (CIBERESP), Madrid (Spain)

2016-09-14

Monitoring of pesticides and veterinary drug residues is required to enforce legislation and guarantee food safety. Liquid chromatography-mass spectrometry (LC-MS) is the prevailing technique for assessing both types of residues because LC offers a versatile and universal separation mechanism suitable for non-gas chromatography (GC) amenable and the majority of GC-amenable compounds. This characteristic becomes more relevant when LC is coupled to MS because the high sensitivity and specificity of the detector allows to apply generic sample preparation procedures, which simultaneously extract a wide variety of residues with different physico-chemical properties. Determination of metabolites and degradation products, non-target suspected screening of an increasing number of residues, and even unknowns identification are also becoming inherent LC-MS advantages thanks to the latest advances. For routine analysis and, in particular, for official surveillance purposes in food control, analytical methods properly validated following strict guidelines are needed. After a brief introduction and an outline of the legislation applicable around the world, aspects such as improvement of specificity of high-throughput methods, resolution and mass accuracy of identification strategies and quantitative accuracy are critically reviewed in this article. In them, extraction, separation and determination are emphasized. The main objective is to offer an assessment of the state of the art and identify research needs and future trends in determining pesticide and veterinary drug residues in food by LC-MS. - Highlights: • An overview of status and future trends in this field. • Analytical method's compliance with guidelines to ensure reliability. • QuEChERS platform is a referent to extract both, pesticides and veterinary drugs in food. • The progress that liquid chromatography has shown in recent years is revised. • Determination of target, non-target and unknowns is

Determination of pesticides and veterinary drug residues in food by liquid chromatography-mass spectrometry: A review

International Nuclear Information System (INIS)

Masiá, Ana; Suarez-Varela, Maria Morales; Llopis-Gonzalez, Agustin; Picó, Yolanda

2016-01-01

Monitoring of pesticides and veterinary drug residues is required to enforce legislation and guarantee food safety. Liquid chromatography-mass spectrometry (LC-MS) is the prevailing technique for assessing both types of residues because LC offers a versatile and universal separation mechanism suitable for non-gas chromatography (GC) amenable and the majority of GC-amenable compounds. This characteristic becomes more relevant when LC is coupled to MS because the high sensitivity and specificity of the detector allows to apply generic sample preparation procedures, which simultaneously extract a wide variety of residues with different physico-chemical properties. Determination of metabolites and degradation products, non-target suspected screening of an increasing number of residues, and even unknowns identification are also becoming inherent LC-MS advantages thanks to the latest advances. For routine analysis and, in particular, for official surveillance purposes in food control, analytical methods properly validated following strict guidelines are needed. After a brief introduction and an outline of the legislation applicable around the world, aspects such as improvement of specificity of high-throughput methods, resolution and mass accuracy of identification strategies and quantitative accuracy are critically reviewed in this article. In them, extraction, separation and determination are emphasized. The main objective is to offer an assessment of the state of the art and identify research needs and future trends in determining pesticide and veterinary drug residues in food by LC-MS. - Highlights: • An overview of status and future trends in this field. • Analytical method's compliance with guidelines to ensure reliability. • QuEChERS platform is a referent to extract both, pesticides and veterinary drugs in food. • The progress that liquid chromatography has shown in recent years is revised. • Determination of target, non-target and unknowns is covered.

Práticas e mudanças no comportamento alimentar na população de Brasília, Distrito Federal, Brasil Behavioral changes in food intake practices in the population of Brasília, Federal District, Brazil

Directory of Open Access Journals (Sweden)

Maria Cristina Sebba Marinho

2007-09-01

Full Text Available OBJETIVOS: investigar as práticas e mudanças alimentares na população de Brasília, Distrito Federal, com as variáveis escolaridade, renda e sexo. MÉTODOS: estudo transversal, com uma amostra probabilística de 500 domicílios, com entrevista a pessoas >15 anos. As entrevistas foram feitas no Plano Piloto, Cidades Satélites e Vila Estrutural do Distrito Federal, entre março de 2003 e março de 2004. O marco amostral foi definido com base nos setores censitários do Instituto Brasileiro de Geografia e Estatística, referentes ao censo demográfico de 2000. Foram sorteados 20 setores censitários dentre os 2548 existentes no Distrito Federal. RESULTADOS: os alimentos consumidos diariamente foram: arroz, feijão, pão, frutas, legumes e verduras. Consumo semanal de frango (85,0%, carne bovina (76,0%, massas (69,6% e ovos (62,0%. A maioria (71,0% relatou preocupar-se com alimentação saudável. Apenas, 37% dos entrevistados relataram mudança alimentar nos últimos seis meses, e dentre eles 32,6% atribuíram à perda de peso, 25,4% à preocupação com a saúde e 20,0% à reeducação alimentar. A mudança foi mantida por 84,2% dos respondentes. CONCLUSÕES: os dados apontam a preocupação com a alimentação saudável e mudanças nas práticas alimentares. As razões alegadas para as mudanças estão relacionadas com a estética e preocupação com a saúde. Renda e escolaridade constituem preditores significativos das mudanças nas práticas alimentares.OBJECTIVES: to investigate food habits changes in the population of Brasília, Federal District through variables such as schooling, income and sex. METHODS: A cross sectional study, with a probabilistic sample of 500 homes through interviews of people aged over 15. The interviews were held at the Plano Piloto, Cidades Satélites and Vila Estrutural regions of the Federal District between March 2003 and March 2004. The sample landmark was defined based on Instituto Brasileiro de Geografia

Proposed Industry Best Practices in Development and Marketing of Medical Foods for the Management of Chronic Conditions and Diseases while Awaiting Regulation.

Science.gov (United States)

Burnett, Bruce; Levy, Robert M

Ideal therapeutics have low toxicity and can effectively manage condition(s) or disease(s). The Food & Drug Administration (FDA) marketing category of therapeutics called “medical foods” (MFs) meets such a definition. Medical foods have existed in Federal law since passage the Orphan Drug Act in 1988, which created a category of nutritional therapeutics separate from drugs. Unfortunately, MFs are not widely understood by the medical community or utilized in all patients who need them due to lack of a FDA-approval process, unclear and contradictory guidance especially with regard for need for an investigational new drug (IND) application, and no clear regulations regarding their development and marketing. The goals of this article are to propose “Best Practices” to guide the medical food industry in the development and marketing of products as well as to serve as a starting point for suggestions regarding further FDA regulation so that therapeutics which are shown to be generally recognized as safe (GRAS), provide food ingredients to meet a distinctive nutritional requirement for a specific condition/disease and are proven effective for the management for that condition/disease can be used to benefit patients who need them.

21 CFR 130.9 - Sulfites in standardized food.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Sulfites in standardized food. 130.9 Section 130.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD STANDARDS: GENERAL General Provisions § 130.9 Sulfites in standardized food...

21 CFR 133.124 - Cold-pack cheese food.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Cold-pack cheese food. 133.124 Section 133.124 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD... Cheese and Related Products § 133.124 Cold-pack cheese food. (a)(1) Cold-pack cheese food is the food...

75 FR 81455 - New Animal Drugs; Deslorelin

Science.gov (United States)

2010-12-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 [Docket No. FDA-2010-N-0002] New Animal Drugs; Deslorelin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

75 FR 1275 - New Animal Drugs; Ractopamine

Science.gov (United States)

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2009-N-0665] New Animal Drugs; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

Roles of "Wanting" and "Liking" in Motivating Behavior: Gambling, Food, and Drug Addictions.

Science.gov (United States)

Robinson, M J F; Fischer, A M; Ahuja, A; Lesser, E N; Maniates, H

2016-01-01

The motivation to seek out and consume rewards has evolutionarily been driven by the urge to fulfill physiological needs. However in a modern society dominated more by plenty than scarcity, we tend to think of motivation as fueled by the search for pleasure. Here, we argue that two separate but interconnected subcortical and unconscious processes direct motivation: "wanting" and "liking." These two psychological and neuronal processes and their related brain structures typically work together, but can become dissociated, particularly in cases of addiction. In drug addiction, for example, repeated consumption of addictive drugs sensitizes the mesolimbic dopamine system, the primary component of the "wanting" system, resulting in excessive "wanting" for drugs and their cues. This sensitizing process is long-lasting and occurs independently of the "liking" system, which typically remains unchanged or may develop a blunted pleasure response to the drug. The result is excessive drug-taking despite minimal pleasure and intense cue-triggered craving that may promote relapse long after detoxification. Here, we describe the roles of "liking" and "wanting" in general motivation and review recent evidence for a dissociation of "liking" and "wanting" in drug addiction, known as the incentive sensitization theory (Robinson and Berridge 1993). We also make the case that sensitization of the "wanting" system and the resulting dissociation of "liking" and "wanting" occurs in both gambling disorder and food addiction.

Drug supply strategies, constraints and prospects in Nigeria.

Science.gov (United States)

Yusuff, K B; Tayo, F

2004-12-01

The study set out to identify the strategies for public drug supply in Nigeria, assess its functionality, and recommend appropriate means to ensure regular availability of safe, efficacious, good quality and affordable essential drugs at public health facilities. The investigation was carried out at the Directorate of Pharmaceutical services, Federal Ministry of Health (F.M.O.H) Abuja and Federal Medical Stores, Oshodi, Lagos. Semi-structured interview was conducted with key informants at the Department of Food & Drugs, Drug procurement unit and Central Medical store using structured questionnaires and direct informants answers. Our study shows that public drug supply in Nigeria is governed by a National Drug Policy (NDP) which was introduced in 1990 and it is yet to be reviewed after ten years. We also identified the Central Medical Store (CMS) system as the current public drug supply strategy in Nigeria. Public drug supply is mainly financed by governments and this is inadequate to ensure sustained availability of essential drugs. The major procurement methods in use are open tender and direct procurement. These methods as presently operated suffer from late order placement, delay in payment and poor supplier lead-time mainly attributable to lateness in payment for previous drug supplies. These have contributed to stock out of essential drugs at public health facilities. Major losses due to expiration and spoilage are recorded at both central and peripheral storage points despite adequacy of storage facilities and personnel. Road transportation was the major mode of drug distribution from central to peripheral storage points and shortage of vehicle was a key factor affecting drug distribution. There was an apparent lack of a functioning drug management information system to effectively coordinate public drug supply and there are no definite systems that monitor and evaluate staff performance. The CMS strategy currently used for public drug supply in Nigeria has

The Federal Health Office in 1990. An information brochure

International Nuclear Information System (INIS)

1991-01-01

The Federal Health Office is the central research institution in the Federal Republic of Germany in the public health sector. Its task is to recognize and assess health hazards, contain such hazards within the framework of its legal competencies, and to provide scientific advice also on such health hazards as arise from the environment. The FHO's research activities are in the fields of health protection and consumer health protection, environmental hygiene, drug safety, and preventive medicine. - Executive tasks have been conferred on the Federal Health Office under the law on drugs and narcotic drugs, epidemics, particides and the use of chemicals, and genetic engineering. (orig./UT) [de

76 FR 6326 - New Animal Drugs; Masitinib

Science.gov (United States)

2011-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 516 [Docket No. FDA-2011-N-0003] New Animal Drugs; Masitinib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

75 FR 79295 - New Animal Drugs; Mupirocin

Science.gov (United States)

2010-12-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 524 [Docket No. FDA-2010-N-0002] New Animal Drugs; Mupirocin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

Directory of Open Access Journals (Sweden)

Nguyen Diane

2013-01-01

Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

48 CFR 852.246-72 - Frozen processed foods.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Frozen processed foods. 852.246-72 Section 852.246-72 Federal Acquisition Regulations System DEPARTMENT OF VETERANS AFFAIRS... Frozen processed foods. As prescribed in 846.302-72, insert the following clause: Frozen Processed Foods...

77 FR 56650 - Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and...

Science.gov (United States)

2012-09-13

...] Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and... entitled ``FDA/American Glaucoma Society (AGS) Workshop on the Validity, Reliability, and Usability of... research. The purpose of this public workshop is to provide a forum for discussing the validity...

21 CFR 314.104 - Drugs with potential for abuse.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drugs with potential for abuse. 314.104 Section 314.104 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... and Abbreviated Applications § 314.104 Drugs with potential for abuse. The Food and Drug...

Food irradiation

International Nuclear Information System (INIS)

Anon.

1984-01-01

Food preservation by irradiation is one part of Eisenhower's Atoms for Peace program that is enjoying renewed interest. Classified as a food additive by the Food, Drug, and Cosmetic Act of 1958 instead of a processing technique, irradiation lost public acceptance. Experiments have not been done to prove that there are no health hazards from gamma radiation, but there are new pressures to get Food and Drug Administration approval for testing in order to make commercial use of some radioactive wastes. Irradiation causes chemical reactions and nutritional changes, including the destruction of several vitamins, as well as the production of radiolytic products not normally found in food that could have adverse effects. The author concludes that, lacking epidemiological evidence, willing buyers should be able to purchase irradiated food as long as it is properly labeled

78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-08-14

..., 301-796-2483; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM- 17), Food and Drug... information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332; and the...

A Summary of the United States Food and Drug Administrations’ Food Safety Program for Imported Seafood; One Country’s Approach

Directory of Open Access Journals (Sweden)

Brett Koonse

2016-04-01

Full Text Available It is well known that the vast majority of seafood is captured or farmed in emerging countries and exported to developed countries. This has resulted in seafood being the number one traded food commodity in the world. Food safety is essential to this trade. Exporting countries should understand the regulatory food safety programs of the countries they ship to in order to comply with their applicable laws and regulations to avoid violations and disruptions in trade. The United States (U.S. imports more seafood than any individual country in the world but the European Union (E.U. countries, as a block, import significantly more. Each importing country has its own programs and systems in place to ensure the safety of imported seafood. However, most countries that export seafood have regulatory programs in place that comply with the import requirements of the E.U. The purpose of this paper is to describe the United States Food and Drug Administration’s (USFDA imported seafood safety program. The primary audience for the information is foreign government regulators, seafood exporters, and U.S. importers. It can also give consumers confidence that f U.S. seafood is safe no matter which country it originates from.

21 CFR 133.173 - Pasteurized process cheese food.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Pasteurized process cheese food. 133.173 Section 133.173 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CHEESES AND RELATED CHEESE PRODUCTS Requirements for Specific...

[Scientific basis in the setting of residue limits for veterinary drugs in food of animal origin taking into account the presence of their metabolites].

Science.gov (United States)

Mitsumori, K

1993-01-01

Maximum residue level (MRL) for veterinary drugs in food of animal origin has been proposed by FAO/WHO, as a new evaluation procedure taking into account the presence of metabolites for the regulation of veterinary drug residues. The MRL is the maximum concentration of residue resulting from the use of a veterinary drug that is recommended to be legally permitted as acceptable in a food. It is established from the Acceptable Daily Intake (ADI) obtained from the data of toxicological studies, the residue concentration of the drug when used according to good practice in the use of veterinary drugs, and the lowest level consistent with the practical analytical methods available for routine residue analysis. Among the veterinary drugs, some chemicals contain a large amount of bound residues that are neither extractable from tissues by the analytical method identical with that used in parent chemicals. Especially, the bioavailable residues which are probably absorbed when the food is ingested are of great toxicological concern. In this case, the FAO/WHO recommends that the MRL can be established after the calculation of daily intake of residues of toxicological concern by the addition of both the extractable and bioavailable bound residues.

A brave new beef: The US Food and Drug Administration's review of the safety of cloned animal products.

Science.gov (United States)

Solomon, Louis M; Noll, Rebekka C; Mordkoff, David S; Murphy, Patrick; Rolerson, Marcy

2009-09-01

To meet its public mandate, the US Food and Drug Administration (FDA) collected studies on the potential health hazards of eating or drinking cloned food products. Based on an earlier National Academy of Sciences study that, on closer analysis, was not nearly as sanguine, the FDA's report found no evidence of a health risk from the public's ingestion of cloned food products. This article analyzes the risks the FDA considered, and concludes that there is a disconnect between the risks the FDA assessed in these studies and the risks that might arise from cloned food products. The FDA should consider instituting effective tracking mechanisms and other diagnostics that would permit scientists and the public to answer the question of health risks posed by cloned food products.

75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

Science.gov (United States)

2010-11-30

... the program expansion including the availability of appropriate staff and sufficient funding. 4. The...] Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product Surveillance... expansion of its Conference Cooperative Agreement Program (U13), awarded to the Engelberg Center for Health...

21 CFR 570.18 - Tolerances for related food additives.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Tolerances for related food additives. 570.18 Section 570.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES General Provisions § 570.18 Tolerances...

21 CFR 1250.35 - Health of persons handling food.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Health of persons handling food. 1250.35 Section 1250.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION INTERSTATE CONVEYANCE...

Iodine Intake through Processed Food: Case Studies from Egypt, Indonesia, the Philippines, the Russian Federation and Ukraine, 2010–2015

Science.gov (United States)

Knowles, Jacky; Shehata, Magdy; Gerasimov, Gregory; Bimo, Bimo; Cavenagh, Bettina; Maramag, Cherry C.; Otico, Edward; Izwardy, Doddy; Spohrer, Rebecca; Garrett, Greg S.

2017-01-01

The current performance indicator for universal salt iodisation (USI) is the percentage of households using adequately iodised salt. However, the proportion of dietary salt from household salt is decreasing with the increase in consumption of processed foods and condiments globally. This paper reports on case studies supported by the Global Alliance for Improved Nutrition (GAIN)-UNICEF USI Partnership Project to investigate processed food industry use of adequately iodised salt in contrasting national contexts. Studies were conducted in Egypt, Indonesia, the Philippines, the Russian Federation, and Ukraine. In all cases, the potential iodine intake from iodised salt in selected food products was modelled according to the formula: quantity of salt per unit of food product × minimum regulated iodine level of salt at production × average daily per capita consumption of the product. The percent of adult recommended nutrient intake for iodine potentially provided by the average daily intake of bread and frequently consumed foods and condiments was from 10% to 80% at the individual product level. The potential contribution to iodine intake from the use of iodised salt in the processed food industry is of growing significance. National USI strategies should encourage co-operative industry engagement and include regulatory monitoring of iodised salt use in the food industry in order to achieve optimal population iodine status. PMID:28933750

21 CFR 133.147 - Grated American cheese food.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Grated American cheese food. 133.147 Section 133.147 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CHEESES AND RELATED CHEESE PRODUCTS Requirements for Specific Standardized...

Toxicity of Xanthene Food Dyes by Inhibition of Human Drug-Metabolizing Enzymes in a Noncompetitive Manner

International Nuclear Information System (INIS)

Mizutani, T.

2010-01-01

The synthetic food dyes studied were rose bengal (RB), phroxine (PL), amaranth, erythrosine B (ET), allura red, new coccine, acid red (AR), tartrazine, sunset yellow FCF, brilliant blue FCF, and indigo carmine. First, data confirmed that these dyes were not substrates for CYP2A6, UGT1A6, and UGT2B7. ET inhibited UGT1A6 (glucuronidation of p-nitrophenol) and UGT2B7 (glucuronidation of androsterone). We showed the inhibitory effect of xanthene dye on human UGT1A6 activity. Basic ET, PL, and RB in those food dyes strongly inhibited UGT1A6 activity, with IC50 values = 0.05, 0.04, and 0.015 mM, respectively. Meanwhile, AR of an acidic xanthene food dye showed no inhibition. Next, we studied the inhibition of CYP3A4 of a major phase I drug-metabolizing enzyme and P-glycoprotein of a major transporter by synthetic food dyes. Human CYP3A4 and P-glycoprotein were also inhibited by basic xanthene food dyes. The IC50 values of these dyes to inhibit CYP3A4 and P-glycoprotein were the same as the inhibition level of UGT1A6 by three halogenated xanthene food dyes (ET, PL, and RB) described above, except AR, like the results with UGT1A6 and UGT2B7. We also confirmed the non inhibition of CYP3A4 and P-gp by other synthetic food dyes. Part of this inhibition depended upon the reaction of O 12 originating on xanthene dyes by light irradiation, because inhibition was prevented by O 12 quenchers. We studied the influence of superoxide dismutase and catalase on this inhibition by dyes and we found prevention of inhibition by superoxide dismutase but not catalase. This result suggests that superoxide anions, originating on dyes by light irradiation, must attack drug-metabolizing enzymes. It is possible that red cosmetics containing phloxine, erythrosine, or rose bengal react with proteins on skin under lighting and may lead to rough skin.

Toxicity of xanthene food dyes by inhibition of human drug-metabolizing enzymes in a noncompetitive manner.

Science.gov (United States)

Mizutani, Takaharu

2009-01-01

The synthetic food dyes studied were rose bengal (RB), phroxine (PL), amaranth, erythrosine B (ET), allura red, new coccine, acid red (AR), tartrazine, sunset yellow FCF, brilliant blue FCF, and indigo carmine. First, data confirmed that these dyes were not substrates for CYP2A6, UGT1A6, and UGT2B7. ET inhibited UGT1A6 (glucuronidation of p-nitrophenol) and UGT2B7 (glucuronidation of androsterone). We showed the inhibitory effect of xanthene dye on human UGT1A6 activity. Basic ET, PL, and RB in those food dyes strongly inhibited UGT1A6 activity, with IC(50) values = 0.05, 0.04, and 0.015 mM, respectively. Meanwhile, AR of an acidic xanthene food dye showed no inhibition. Next, we studied the inhibition of CYP3A4 of a major phase I drug-metabolizing enzyme and P-glycoprotein of a major transporter by synthetic food dyes. Human CYP3A4 and P-glycoprotein were also inhibited by basic xanthene food dyes. The IC(50) values of these dyes to inhibit CYP3A4 and P-glycoprotein were the same as the inhibition level of UGT1A6 by three halogenated xanthene food dyes (ET, PL, and RB) described above, except AR, like the results with UGT1A6 and UGT2B7. We also confirmed the noninhibition of CYP3A4 and P-gp by other synthetic food dyes. Part of this inhibition depended upon the reaction of (1)O(2) originating on xanthene dyes by light irradiation, because inhibition was prevented by (1)O(2) quenchers. We studied the influence of superoxide dismutase and catalase on this inhibition by dyes and we found prevention of inhibition by superoxide dismutase but not catalase. This result suggests that superoxide anions, originating on dyes by light irradiation, must attack drug-metabolizing enzymes. It is possible that red cosmetics containing phloxine, erythrosine, or rose bengal react with proteins on skin under lighting and may lead to rough skin.

21 CFR 516.161 - Modifications to indexed drugs.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Modifications to indexed drugs. 516.161 Section 516.161 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Index...

21 CFR 312.7 - Promotion of investigational drugs.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Promotion of investigational drugs. 312.7 Section 312.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION General Provisions § 312.7 Promotion of...

21 CFR 558.6 - Veterinary feed directive drugs.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Veterinary feed directive drugs. 558.6 Section 558.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS General Provisions...

48 CFR 223.570 - Drug-free work force.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Drug-free work force. 223.570 Section 223.570 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM... TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 223.570 Drug-free work force. ...

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