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

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.

1996 ◽  
Vol 59 (8) ◽  
pp. 876-880 ◽  
Author(s):  
RAJESH VENUGOPAL ◽  
LINDA TOLLEFSON ◽  
FREDERICK N. HYMAN ◽  
BAB TIMBO ◽  
RONALD E. JOYCE ◽  
...  

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.


2013 ◽  
Vol 76 (6) ◽  
pp. 932-938 ◽  
Author(s):  
MANASHI DEY ◽  
JONATHAN A. MAYO ◽  
DEBORAH SAVILLE ◽  
CECILIA WOLYNIAK ◽  
KARL C. KLONTZ

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.


2019 ◽  
Vol 366 (23) ◽  
Author(s):  
Edward Cunningham-Oakes ◽  
Rebecca Weiser ◽  
Tom Pointon ◽  
Eshwar Mahenthiralingam

ABSTRACT Preventing microbial contamination of non-food products is a major area of industrial microbiology where preservatives are used to stop microbial growth. However, microorganisms occasionally overcome product preservation, causing recalls and the implementation of multiple procedures to prevent further contamination. Correct reporting of microbial contamination in non-food industrial products is vital, especially if spoilage organisms are antimicrobial resistant and pose a health threat. Gram-negative bacteria such as Pseudomonas, Burkholderia and Enterobacteriaceae are frequently reported as non-food product contaminants, including species that overlap current antimicrobial resistance priorities. Historical analysis of recall databases highlighted that for greater than 15% of contamination incidents, the causative microbial agents are reported as unidentified. Here we review the current antimicrobial resistant bacterial species associated with non-food product contamination and evaluate recall reporting in Europe from 2005 to 2018. Our review shows that 49% of microbial contaminants are reported as unidentified despite frequent detection of antimicrobial resistant pathogens; in contrast, 98% of food-related microbial contaminants are classified. Recommendations to fill this microbial identification gap in non-food product recalls are made. Overall, reporting standards for microbial contamination in non-food products must be improved to enable surveillance and for understanding the risks associated with antimicrobial resistant microorganisms


Author(s):  
Joshua M. Sharfstein

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.


2021 ◽  
pp. 174077452110505
Author(s):  
Dionne Price ◽  
John Scott

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.


2018 ◽  
Vol 2 (2) ◽  
Author(s):  
Saya L Jacob ◽  
Erika Cornell ◽  
Michael Kwa ◽  
William E Funk ◽  
Shuai Xu

Abstract There have been numerous controversies surrounding cosmetic products and increased cancer risk. Such controversies include associations between parabens and breast cancer, hair dyes and hematologic malignancies, and talc powders and ovarian cancer. Despite the prominent media coverage and numerous scientific investigations, the majority of these associations currently lack conclusive evidence. In 2016, the US Food and Drug Administration (FDA) made publically available all adverse event reports in Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS), which includes complaints related to cosmetic products. We mined CAERS for cancer-related reports attributed to cosmetics. Between 2004 and 2017, cancer-related reports caused by cosmetics represented 41% of all adverse events related to cosmetics. This yielded 4427 individual reports of cancer related to a cosmetic product. Of these reports, the FDA redacted the specific product names in 95% of cancer-related reports under the Freedom of Information Act exemptions, most likely due to ongoing legal proceedings. For redacted reports, ovarian cancer reports dominated (n = 3992, 90%), followed by mesothelioma (n = 92, 2%) and malignant neoplasm unspecified (n = 46, 1%). For nonredacted reports, or those reports whose product names were not withheld (n = 218), 70% were related to ovarian cancer attributed to talc powders, followed by skin cancer (11%) and breast cancer (5%) attributed to topical moisturizers. Currently, CAERS is of limited utility, with the available data having been subjected to significant reporter bias and a lack of supportive information such as demographic data, medical history, or concomitant product use. Although the system has promise for safeguarding public health, the future utility of the database requires broader reporting participation and more complete reporting, paired with parallel investments in regulatory science and improved molecular methods.


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