Recalls of Foods and Cosmetics by the U.S. Food and Drug Administration

1996 ◽  
Vol 59 (8) ◽  
pp. 876-880 ◽  
Author(s):  
RAJESH VENUGOPAL ◽  
LINDA TOLLEFSON ◽  
FREDERICK N. HYMAN ◽  
BAB TIMBO ◽  
RONALD E. JOYCE ◽  
...  
Keyword(s):  
Drug Administration ◽  
Microbial Contamination ◽  
Food And Drug Administration ◽  
Food Products ◽  
Class I ◽  
Regulatory Agencies ◽  
Health Consequences ◽  
Cooperative Effort ◽  
Adverse Health ◽  
The U.S

Recalls of foods and cosmetics from the marketplace are an expeditious and effective method of removing violative products, particularly those that present a danger to health. Recalls are undertaken through a cooperative effort by industry and the U.S. Food and Drug Administration (FDA). Foods and cosmetics recalled from the period 1 October 1991 through 30 September 1992 were reviewed to determine the kinds of products recalled and the reasons for recall. A total of 230 recalls, involving 569 foods and cosmetics, occurred during the study period. Twenty-eight percent of the recalls were designated class I, defined as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences. The problems for which foods or cosmetics were most often recalled were misbranding and microbial contamination (37% and 25% of recalls, respectively). A recognized illness or injury was reported to have occurred in association with 32 food products and one cosmetic. This study indicates that recalls of foods and cosmetics are common and that various groups, including industry, consumers, state regulatory agencies, and the FDA, recognize problems leading to recall.

Recalls of Foods and Cosmetics Due to Microbial Contamination Reported to the U.S. Food and Drug Administration

2000 ◽  
Vol 63 (8) ◽  
pp. 1113-1116 ◽  
Author(s):  
STEPHANIE WONG ◽  
DEBRA STREET ◽  
SONIA I. DELGADO ◽  
KARL C. KLONTZ
Keyword(s):  
Drug Administration ◽  
Dairy Products ◽  
Microbial Contamination ◽  
Food And Drug Administration ◽  
Food Product ◽  
Food Products ◽  
Regulatory Agencies ◽  
Product Recalls ◽  
Cosmetic Products ◽  
The U.S

In the U.S., food product recalls serve as an important intervention in stemming the consumption of food products contaminated with infectious disease agents. We summarize the number and nature of foods and cosmetics recalled as a result of microbial contamination reported to the U.S. Food and Drug Administration (FDA) for the period 1 October 1993 through 30 September 1998. During this period, microbial contamination of food and cosmetic products was the leading cause for recalls, accounting for a total of 1,370 recalls (36% of all products recalled). Listeria monocytogenes accounted for the greatest number of food products recalled because of microbial contamination, whereas Pseudomonas aeruginosa was the most common microbe associated with recalls of cosmetic products. Dairy products, followed by seafood and pastry items, were the types of products most often associated with recalls due to microbial contamination. The FDA was the entity most often responsible for detecting microbial contamination of foods and cosmetics (33% of all such recalls), followed by state regulatory agencies (24%), and manufacturers/retailers (21%). Nineteen percent of recalls were associated with at least one reported case of illness. Salmonella was the pathogen most often implicated in reports of illness associated with these recalled products.

Recalls of Foods due to Microbiological Contamination Classified by the U.S. Food and Drug Administration, Fiscal Years 2003 through 2011

2013 ◽  
Vol 76 (6) ◽  
pp. 932-938 ◽  
Author(s):  
MANASHI DEY ◽  
JONATHAN A. MAYO ◽  
DEBORAH SAVILLE ◽  
CECILIA WOLYNIAK ◽  
KARL C. KLONTZ
Keyword(s):  
Infectious Diseases ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Food Products ◽  
Microbiological Contamination ◽  
Seafood Products ◽  
Edible Seeds ◽  
The U.S

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.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date

2021 ◽  
pp. 174077452110505
Author(s):  
Dionne Price ◽  
John Scott
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Trial Design ◽  
Drug Evaluation ◽  
Food And Drug Administration ◽  
Medical Product ◽  
Global Public Health ◽  
Multiple Sources ◽  
Meeting Program ◽  
The U.S

Background The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration have been leaders in advancing science to protect and promote public health by ensuring that safe and effective drugs and biological products are available to those who need them. Recently, new therapeutic discoveries, increased understanding of disease mechanisms, the need for innovation to optimally use resources, and global public health crises have led to an evolving drug development landscape. As a result, the U.S. Food and Drug Administration and medical product developers are faced with unique challenges and opportunities. The U.S. Food and Drug Administration is proactively meeting the challenges of this evolving landscape through various efforts, including the Complex Innovative Trial Design Pilot Meeting Program. Our focus, here, will be on the pilot meeting program. Methods The U.S. Food and Drug Administration has defined a process to facilitate the implementation of the Complex Innovative Trial Design Pilot Meeting Program. The process is transparent and outlines the steps and timeline for submission, review, and meetings. Results Five submitted meeting requests have been selected for participation in the Complex Innovative Trial Design Pilot Meeting Program. Conclusion The pilot meeting program has been successful in further educating stakeholders on the potential uses of complex innovative designs in trials intended to provide substantial evidence of effectiveness. The selected submissions, thus far, have all utilized a Bayesian framework. The reasons for the use of Bayesian approaches may be due to the flexibility provided, the ability to incorporate multiple sources of evidence, and a desire to better understand the U.S. Food and Drug Administration perspective on such approaches. We are confident the pilot meeting program will have continued success and impact the collective goal of bringing safe and effective medical products to patients.

Evaluation of Orphan Products by the U.S. Food and Drug Administration

1992 ◽  
Vol 8 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Marlene E. Haffner ◽  
John V. Kelsey
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Marketing Approval ◽  
Drug Products ◽  
Governmental Agencies ◽  
Number Of Patients ◽  
Life Threatening ◽  
The U.S

AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

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