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  • Unlike other product categories regulated by FDA, FDA’s authority over cosmetic products marked in the United States is limited. FDA lacks mandatory recall authority for cosmetics, and manufacturers are not legally required to disclose adverse health effects reported by consumers. Ultimately, companies and individuals who market these products in the U.S. bear the responsibility for the safety and labeling of their products.
  • In 2017, FDA become aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. On Sept. 5, 2017 Justice voluntarily recalled the suspect products, and on December 22, 2017, Claire’s removed a number of products from its stores. In a statement on March 5, 2019, former FDA Commissioner Dr. Scott Gottlieb and Dr. Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition explained that after Claire’s withdrew and Justice recalled the suspect products, FDA conducted independent tests to determine if some of these products did, in fact, contain asbestos. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice.
  • While suspect Justice products, including the one that tested positive for asbestos were previously recalled from the market, FDA noted that Claire’s has refused to comply with the Agency’s request to recall the products. Because the Agency does not have authority to mandate a recall, FDA issued a Safety Alert, warning consumers to not use three of Claire’s products because they tested positive for asbestos. In essence, the Agency utilized the statement in this case to publicly announce their alleged safety concerns with the products and to point out that Claire’s had failed to comply with FDA’s request. While not a recall, this statement represents a powerful tool for the Agency to communicate concerns with respect to cosmetics.
  • On Tuesday, March 5, FDA Commissioner Scott Gottlieb announced he would resign at the end of the month. Gottlieb, a physician and former deputy commissioner in the George W. Bush administration, was confirmed as FDA Commissioner in May 2017. The resignation was not sought by the White House, as confirmed by a senior White House official. Rather Gottlieb, who commutes weekly to Washington from Connecticut, said he wants to spend more time with his family. In a letter to FDA staff, Gottlieb noted “[t]here’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family these past two years and missing my wife and three young children.”
  • Unlike some former commissioners, during his tenure, Gottlieb focused much of his time on issues related to food and tobacco. For example, as part of its 2018 Strategic Policy Roadmap, FDA signaled its intent to modernize certain standards of identity (SOI) to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat.  Relatedly, under Gottlieb’s direction, FDA requested comments on the use dairy terms in the labeling of plant-based products. See our previous posts on SOI modernization and the plant-based products labeling debate. As for food safety, examples of FDA action include plans to modernize oversight of imported food and the investigation of several product recalls, including the November 2018 romaine lettuce E. coli outbreak. And in April 2018, FDA issued its first ever mandatory recall. Additionally, Commissioner Gottlieb dedicated his efforts to reducing tobacco-related disease and death and curtailing youth access to tobacco products and e-cigarettes. Tobacco- and e-cigarette-related posts can be found here.
  • Prior to his departure, Commissioner Gottlieb vowed to continue to work to cement more of FDA’s pending efforts, to secure the 2020 budget, and to help transition the agency to new leadership. At this time, Commissioner Gottlieb’s replacement has not been announced.
  • The U.S. Food and Drug Administration (FDA) discusses how the Agency is integrating new tools, that are a result of the passage of the Food Safety Modernization Act (FSMA),  with existing ones to improve the safety of imported foods in a newly released publication, “Strategy for the Safety of Imported Food.” (For background information on these new tools, see our previous blogs on the Foreign Supplier Verification Program (FSVP), the Accredited Third-Party Certification program’ and the Voluntary Qualified Importer Program (VQIP).)
  • Noting that the U.S. imports about 15% of its overall food supply from more than 200 countries or territories, FDA explained that the volume and variety of imported food and the complexity of global supply chains make food safety a challenging issue to address. Below is a brief summary of the goals that FDA has outlined in the Strategy document.
  • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements. This involves optimizing the use of foreign inspection, effective implementation of the FSVP, use of reliable third-party audits and the VQIP. In addition, FDA will collaborate with foreign governments, standards development organizations, and others. For example, FDA has made system recognition arrangements with New Zealand, Canada, and Australia and is working with the European Union on a mutual assessment.
  • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods. FDA’s surveillance of imported food at more than 300 active U.S. ports of entry generally involves screening, examination, sampling, and testing. The Agency plans on incorporating new sources of information into import screening and expanding testing methods. Additionally, FDA will collaborate with state and other regulatory authorities; use import alerts; and require import certification as a condition of admission, where appropriate.
  • Goal 3 – Rapid and Effective Response to Unsafe Imported Food. While FSMA granted FDA mandatory recall authority, voluntary recalls are still the primary means to remove “violative products” from the U.S. food supply. Reaching this goal will also involve gaining greater access to information from foreign sources and maximizing effectiveness of response to an event involving imported food. FDA also plans to further develop and refine processes to enable use of Agency authorities to prevent importation of unsafe food from facilities, including those with suspended registrations.
  • Goal 4 – Effective and Efficient Food Import Program. FDA will develop an improved global inventory of food facilities and farms to optimize resource allocation for imported food safety oversight to areas of higher risk.
  • In a statement on FDA’s new strategy to advance oversight of imported food, FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas concluded, “Overall, our modern strategy is designed to leverage our different authorities and tools to provide a multi-layered, data-driven, smarter approach to imported food safety.”

 

  • As reported here, the domestic and import inspection program for Siluriformes fish and fish products (including catfish) was transferred from FDA to USDA in response to a congressional mandate.  After September 1, 2017, only foreign countries that had submitted documentation showing the equivalence of their Siluriformes fish inspection system with that of the U.S. could continue exporting these products to the U.S.  Additionally, as of August 2, 2017, all shipments of imported Siluriformes entering the U.S. must be presented at an Official Import Inspection Establishment for re-inspection by USDA Food Safety and Inspection Service (FSIS) personnel.
  • FSIS routinely monitors distributors and cold storage facilities for “failure to present violations.”  Recent recalls suggest that enforcing the re-inspection requirement of the Siluriformes fish inspection system is an important priority for FSIS.  See Fulton Seafood (February 22, 2019), TV Food (February 22, 2019), Richwell Group (February 5, 2019), American Best (February 4, 2019), H&T Seafood (January 18, 2019) and Mannarich Food (December 15, 2018).
  • The recall classification for products that are violative on account of not being presented for FSIS re-inspection as required is Class I ( i.e., “involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death”).  Further, FSIS routinely issues health alerts for such products although they have not typically been associated with other actionable defects or reports of adverse reactions due to consumption.

 

  • As reported on this blog, on February 13, 2019, FDA released findings from the Agency’s investigation of the November 2018 outbreak of E. coli O157:H7 infections involving romaine lettuce. Those findings concluded that water from on-farm water reservoir, which was likely not effectively sanitized, most likely led to contamination of some of the romaine lettuce. In a statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Frank Yiannas, the leaders noted that moving forward, “[o]ur first goal is working with federal, state and industry partners on implementing best practices to try and prevent these outbreaks in the first place.”
  • The recent romaine lettuce outbreaks in 2018 occurred after FDA sought to extend the compliance dates for the agricultural water requirements of the Produce Safety Rule by an additional two to four years (for produce other than sprouts) in a September 2017 Proposed Rule. (82 FR 42963). The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively.
  • Chair of the Congressional Food Safety Caucus, Congresswoman Rosa DeLauro condemned FDA’s delay of the Produce Safety Rule in light of the report on the romaine lettuce recall. “The FDA’s investigations into last year’s romaine lettuce recalls have confirmed what we already knew to be true: dirty irrigation water contaminates produce and makes people sick…Eight years after the Food Safety Modernization Act was signed into law, it is long past time these important rules went into effect—not delayed into the next decade.” FDA has yet to finalize its proposed extension of the Produce Safety Rule’s agricultural water requirements.
  • As previously reported on this blog, in November 2018 FDA, in conjunction with the CDC, state officials, and Canadian food and public health officials, investigated an outbreak of E. coli O157:H7 infections in multiple US states and Canadian provinces. The investigation determined the cause of the outbreak was the consumption of contaminated romaine lettuce. Indeed, thirty (83%) of 36 ill consumers interviewed reported eating romaine lettuce the week before illness onset. All E. coli O157:H7 isolates from ill consumers had a rare genetic fingerprint, as determined by whole genome sequencing (WGS), that was closely related to one previously seen in ill consumers in the fall of 2016 and the fall of 2017. The November 2018 outbreak was declared over in the US on January 9, 2019.
  • On February 13, 2019, FDA released the findings from the Agency’s investigation of the November 2018 outbreak. With the help of WGS, investigators were able to narrow down the growing location of the romaine lettuce to specific California counties. The traceback investigation further identified multiple farms that may have been the cause of the outbreak.
  • In their report, FDA identified factors that most likely contributed to the contamination of romaine lettuce, specifically from one farm in Santa Maria in Santa Barbara County, California. Those factors include the following:
    • The outbreak strain of E. coli O157:H7 was found in the sediment of an on-farm water reservoir in Santa Maria.
    • The outbreak strain was not found anywhere else in sampling done during the investigation in various California leafy greens growing areas and counties.
    • The water from the on-farm water reservoir most likely led to contamination of some of the romaine lettuce. The water was likely not effectively sanitized. The water may have come in contact with the romaine through multiple avenues, including direct harvest/postharvest application and/or use of water on harvest equipment.
    • FDA is not sure how the water became contaminated.
    • Other ranches owned by the same farm, as well as other farms, may have sold contaminated lettuce.
    • Due to the fact that the same specific strain of E. coli O157:H7 occurred in 2016 and 2017, it may be likely that the strain remained in the environment or repeatedly introduced from an unknown source.
  • Based on these findings, FDA provided recommendations for the prevention of future outbreaks. Such recommendations include adhering to the recommendations of the Environmental Assessment associated with the spring 2018 STEC outbreak, FSMAs Produce Safety Rule, and FSMAs Preventive Controls for Human Foods Rule. And specifically for growers of leafy greens, FDA recommends assessing the growing operations, assuring all agricultural water is safe and of adequate sanitary quality, and performing a root cause analysis when a foodborne pathogen is identified.
  • The findings provide hope that growers and public health officials will be able to prevent or mitigate potential future outbreaks.

The full FDA report can be accessed here.

  • The Minnesota Department of Agriculture (MDA) has issued a recall notice for three lots of raw turkey pet food manufactured by Woody’s Pet Food Deli after linking a human case of Salmonella Reading infection to the product.
  • The infected person served the recalled food to a pet, which also tested positive for Salmonella but a strain other than Salmonella Reading.  This is the second time MDA has issued a recall relating to a human Salmonella Reading infection from raw turkey pet food; the first was a year ago in February 2018, when two children in the Twin Cities metro area were infected—one of whom was hospitalized.
  • The Woody’s Pet Food is the latest of many raw turkey products that have been implicated in the human Salmonella Reading outbreak that has been ongoing since November 2017.  Since we last reported on the outbreak in November 2018, the rate of new illnesses has increased, with more than 50 new cases occurring in the past two months, bringing the total to 216 cases.
  • As previously reported on this blog, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact both the U.S. Department of Agriculture and the U.S. Food and Drug Administration. This blog has also reported that as of January 15, FDA resumed inspections of food facilities that produce high risk foods, such as cheeses, other dairy products, seafood, produce, and infant formula, which had been stopped as a result of the federal government shutdown.
  • On January 20, FDA Commissioner Dr. Scott Gottlieb said in a series of tweets that, as part of the efforts to conduct and support domestic food surveillance inspections of high risk products, a total of 100 investigators and 35 supervisors were called back and that “more staff could be on the way depending on needs.” In addition, FDA’s Office of Import and Enforcement Operations, which covers International Mail Facilities and ports of entry, has about 450 FDA staff in the field supporting critical operations, Gottlieb said.
  • On January 16, USDA announced that 2,500 workers were being called back to reopen about half of its Farm Service Agency (FSA) to provide limited services for farmers and ranchers. Those workers temporarily returned to work on January 17, 18 and 22 to help farmers with existing loans and tax documents. It has also been reported that about 90 percent of USDA’s 9,500 Food Safety and Inspection Service (FSIS) employees remain on the job but are working without pay.
  • The United State Public Interest Research Group (PIRG) published “How Safe is Our Food? Recent trends and case studies, and what they mean for our health”, a review and commentary of the food safety system in the United States.  PIRG reviewed trends in food safety, with an emphasis on recalls, as well as case studies of seven recent recalls.
  • Of note, PIRG points to the increased number of recalls as evidence that the food safety requirements are not sufficiently stringent.  PIRG acknowledges that the increase in recalls may be due to improved surveillance and testing, but that this “demonstrate[s] that there were previously unidentified problems in the food supply. If the levels of contamination and outbreak being identified were always present and just now being identified, this shows that the safety problems in the food system are still in need of work.”  PIRG also points to large operation farms, the presence of feed lots near vegetable farms, and insufficient regulations and regulatory oversight.  FDA Commissioner Scott Gottlieb tweeted that increased recalls have likely been due to new tools to detect pathogens and that increased complexity of food chains means a single tainted ingredient may result in the recall of many products.
  • CDC, in its Morbidity and Mortality Weekly Report from January 4, published a case study of Whole Genome Sequencing (WGS)used to identify the source of Salmonella in backyard poultry.  The Daily Intake Blog has published many posts about the increased use of WGS, and CDC’s recently published case study is the most recent example of WGS’s use in identifying pathogen sources and the tension between increased recalls/violative product and a safer food supply.
  • For more on FDA’s food safety regulations, see the Daily Intake Blog posts here.  We have also published extensively on food recalls here.
  • As previously reported on this blog, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce. This latest outbreak, which began in the Fall 2018, is not related to the E.coli outbreak that occurred in the Spring 2018. We’ve previously covered the Spring 2018 outbreak, which was officially declared over on June 28 and may have been caused by concentrated animal feeding operations in the Yuma, Arizona area.
  • FDA determined in November 2018 that the Fall 2018 E.coli outbreak was linked to romaine lettuce grown in California during the fall of 2018. Consequently, under an agreement between FDA and a number of grower shippers, grower shippers agreed to label their romaine products with the region where they were grown and the approximate harvest date.
  • In its final update on the Fall 2018 outbreak of E. coli O157:H7 infections linked to romaine lettuce, the CDC declared that the outbreak appeared to be over. In total, from October 7, 2018 to December 4, 2018, there were 62 cases from 16 states and the District of Columbia. CDC previously identified the outbreak strain of E. coli O157:H7 in sediment collected within an agricultural water reservoir on an Adam Bros, Inc. farm in Santa Barbara County. The update notes that FDA is continuing to investigate how the E. coli bacteria could have entered the agricultural water reservoir, ways romaine lettuce from the farm could have been contaminated, and whether there are other sources of the outbreak.