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  • On May 17, House Appropriations Committee Chair Rosa DeLauro (D-CT) introduced H.R. 7790, a supplemental appropriations bill to provide $28 million in emergency funding to address the shortage of infant formula in the US for the fiscal year ending September 30, 2022. The bill is intended to provide the FDA with needed resources to address the shortage, prevent fraudulent products from being sold, acquire better data on the infant formula marketplace, and to help prevent a future recurrence.
  • Representative DeLauro stated that FDA does not currently have an adequate inspection force to inspect more plants if it approves additional applications to sell formula in the US. Thus, the supplemental appropriations are intended for “salaries and expenses.”
  • Relatedly, the House Appropriations Committee will hold two hearings this week to examine the recent recall of infant formula, the FDA’s handling of the recall, and the nationwide infant formula shortage.
  • On May 10, 2022, FDA published a news release in which it highlighted its efforts to improve the supply of infant and specialty formula products.  This follows a warning from FDA to not use certain powdered infant formulas and a voluntary recall of those products.
  • FDA acknowledged that many consumers have not been able to access the infant formulas and medical foods that they were accustomed to using. FDA stated that it is working to ensure there is adequate product available where and when it is needed. In this regard, FDA states that it is “leveraging all the tools at its disposal” to support the infant formula product supply, including:
    • Expediting the review of notifications and manufacturing changes to help manufacturers bring safe products to market;
    • Monitoring the infant formula supply by using the 21 Forward food supply chain continuity system;
    • Expediting certificates for imports to allow for flexibility in the movement of already-permitted products into the U.S. and offering a streamlined import entry review process; and
    • Exercising enforcement discretion on minor labeling issues.
  • FDA emphasized that only facilities that are “experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risk to consumers” and continues to advise against making infant formulas at home.

 

  • On April 11, Senator Patty Murray (D-WA), who leads the Senate Committee on Health, Education, Labor, and Pensions, sent a letter to FDA Commissioner Robert Califf about her concerns over a report that described “longstanding, significant delays and dysfunction across food safety efforts” at the Agency and requests that the Commissioner make food safety issues a priority and take immediate action to ensure the FDA fulfills all aspects of its public health mission. Senator Murray goes further stating that “[t]he FDA’s failure over decades to regulate and enforce food safety standards, on issues ranging from bacteria in vegetables to arsenic in baby food, has put the health of Americans at risk.”
  • Referring to a recent report from Politico, Senator Murray states that the FDA’s predominant focus has been on drugs and devices, despite overseeing nearly 80% of the American food supply. In her letter, Senator Murray notes she is concerned the FDA has not yet imposed strict safety standards with regards to heavy metals found in baby food, finalized long-term voluntary reduction targets for sodium in food, or ensured timely inspections and recalls, which are “critical for ensuring food is free of bacteria and other harmful contaminants.”
  • By April 25, Senator Murray requests the Agency provide her with the following information:
    • Steps the FDA is taking or planning to take to improve food safety efforts, including the timeliness and rigor of regulatory and enforcement activities;
    • Whether the FDA has assessed the causes of delays in addressing water used to grow produce, heavy metals in baby food, and sodium levels in food. If so, what were the results of the assessments;
    • Steps the FDA is taking to ensure the Agency’s organizational structure supports timely and effective food-related decision-making; and
    • The number of food safety inspections conducted over the past 10 years, as well as the number of food and food packaging samples tested for toxic elements.
  • Senator Murray has not been the only Congress member with concerns. Representative Frank Pallone (D-NJ) tweeted that he is requesting a briefing from the Agency, and House Appropriations Chair Rosa DeLauro (D-Conn) also tweeted “The ‘F’ in FDA has come to mean ‘failure’ on food safety. We must greatly intensify the pressure to get the FDA to do its job and to keep American people safe and alive.”
  • Yesterday, March 28, 2022, FDA announced that a New Jersey District Court has entered a consent decree of permanent injunction against Bravo Packing, Inc.,* a New Jersey animal food manufacturer, and two of its owners and operators, Joseph Merola and Amanda Lloyd. See also Department of Justice (DOJ) Press Release.
  • It is the first consent decree of permanent injunction that has been entered against an animal food manufacturer for violating the current good manufacturing practice (CGMP) requirements for animal food in 21 CFR, Part 507. FDA had inspected the company’s facilities in 2019 and 2021 and found insanitary conditions, CGMP violations, and samples of finished product which tested positive for Salmonella and Listeria monocytogenes. FDA also issued a warning letter in 2020 in response to the findings in its 2019 inspections.
  • DOJ, which litigates on behalf of FDA, filed a complaint on March 15, 2022, alleging that Defendants had introduced adulterated food into interstate commerce. The consent decree reflects a negotiated injunction, which avoids the need for litigation over the terms of the injunction. The decree prohibits Defendants from receiving, preparing, processing, packing, holding, labeling, and/or distributing pet food unless and until the company completes corrective actions, and also provides FDA with other enforcement tools if Defendants fail to comply.
  • Although FDA usually seeks voluntary corrective actions, this case is a reminder that the Agency may pursue more forceful judicial remedies for serious and/or repeat violations. More specifically, FDA’s Regulatory Procedures Manual states that the Agency will favor an injunction when: (1) There is a current and definite health hazard or a gross consumer deception requiring immediate action to stop the violative practice and a seizure is impractical; (2) There are significant amounts of violative products owned by the same person, a voluntary recall by the firm was refused or is significantly inadequate to protect the public, and a seizure is impractical or uneconomical; or (3)There are long-standing (chronic) violative practices that have not produced a health hazard or consumer fraud, but which have not been corrected through voluntary or other regulatory approaches.

*Please note that Bravo Packing Inc. has no relationship or association with Bravo Pet Foods, located in Manchester, CT.

  • On March 16, 2022, FDA announced its findings from a sampling assignment in which the Agency collected and tested processed avocado and guacamole from November 2017 to September 2019. The assignment tested for Salmonella spp. and Listeria monocytogenes, as part of FDA’s efforts to proactively ensure food safety.
  • FDA collected and tested 887 samples of domestic and imported processed avocado and guacamole. Salmonella spp. was found in 2 samples – neither of which had received high pressure processing (HPP) treatment, which is often used to neutralize harmful pathogens.  Listeria monocytogenes was detected in 15 samples, 8 of which had not received HPP treatment. When FDA encountered a pathogen in a sample, the Agency worked to remove all affected products from the market. The Agency also conducted whole genome sequencing on the positive samples but was unable to determine if they were associated with any known illnesses.
  • FDA’s sampling assignment confirmed that Salmonella spp. and Listeria monocytogenes may be present in processed avocados and guacamole. It also supported that HPP is effective at neutralizing pathogens. FDA will continue to sample processed avocado and guacamole for pathogens.
  • On January 5, 2022, FDA published an interactive public data dashboard that will allow anyone to view historical data from the Reportable Food Registry (RFR).  The RFR is a tool that the food industry uses to alert FDA of dangerous food products.  FDA has stated that this dashboard will be a more efficient and less resource intensive process for the agency to provide data to the public.
  • The RFR dashboard includes over 10 years of data, covers 28 commodities, and addresses 20 food safety hazards. Unlike the past RFR annual reports, the new dashboard allows users to interact with the data to get customized information on specific trends, commodities, hazards, and time frames.
  • FDA has also announced that the agency will begin a project in 2022 to allow companies to export the RFR data from their business systems directly to the portal.  Once complete, companies will be able to upload RFR reports to the Safety Reporting Portal, where product safety issues are reported to FDA.  The information will then be distributed simultaneously to both the RFR and Recalls Programs.  FDA anticipates that this update will become available in 2023.
  • Histamine and other spoilage compounds can form when certain fish species, such as tuna and mahi-mahi, are not chilled promptly after death and maintained in a chilled state, or otherwise treated or processed to prevent microbial activity.  Histamine cannot reliably be removed by washing, freezing, or heating.  As discussed in a recent recall of frozen tuna steak, histamine can produce an allergic reaction called scombroid fish poisoning with symptoms, including a tingling or burning sensation in the mouth, facial swelling, rash, hives and itchy skin, nausea, vomiting or diarrhea, that can appear within minutes to several hours after eating affected fish.
  • On December 27, 2021, FDA published notice of the availability of a draft Compliance Policy Guide (CPG), titled “Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine (CPG 7108.24),” which would update and replace existing guidance for FDA staff on adulteration associated with decomposition and histamine identified during surveillance sampling and testing of fish and fishery products susceptible to scombrotoxin (histamine) formation.  The draft CPG would revise two guidance levels for the presence of histamine in these fish as follows:
    • If samples have 35 parts per million (ppm) or more histamine (lowered from 50 ppm), FDA may consider the fish to be adulterated because they are decomposed and/or produced under insanitary conditions.
    • If samples have 200 ppm or more histamine (lowered from 500 ppm), FDA may consider the fish to be adulterated based on the presence of a deleterious substance (histamine) which may render them injurious to human health.

The CPG notes that elevated histamine levels can be prevented in fish by adherence to Current Good Manufacturing Practices and Hazard Analysis Critical Control Point (HACCP) principles required by FDA’s Fish and Fishery Products regulation.

  • FDA has requested feedback on the draft CPG (docket number FDA-2021-D-0367).  The comment period will be open for 60 days, until February 25, 2022.
  •  Our readers will recall a 2019 agreement by the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) on joint oversight of the production of cell-cultured products from animals traditionally under FSIS jurisdiction (livestock, poultry, and catfish).  Under the agreement FDA will oversee cell collection, growth and differentiation and FSIS will oversee cell harvesting, processing, packaging, and labeling.  As discussed in detail here, on September 3, 2021, FSIS published an advanced notice of public rulemaking (ANPR) seeking comment on the labeling of cell-cultured meat and poultry products.
  • FSIS announced on November 12, 2021 that in response to several stakeholder requests, the comment period for submitting information solicited in the ANPR on the labeling of cell-cultured meat and poultry products, which was initially set to close on November 2, 2021, will be extended by an additional 30 days.  Among the broad range of questions for comment, the main issue is whether labeling should differentiate cell-cultured products from traditionally slaughtered products, and if so, what terms should be used.  The labels of any cell-cultured meat or poultry products marketed before rulemaking is completed must clearly differentiate the products from slaughtered meat and poultry products, and such labels may need to be changed once final regulations are implemented.
  • The comment period on labeling of cell-cultured meat and poultry products will now end on December 2, 2021.  We will be happy to assist interested parties in submitting comments in response to the ANPR.
  • On October 25, 2021, FDA issued its final results from a year-long sampling assignment to test talc-containing cosmetic products for the presence of asbestos. All 50 samples tested negative for detectable asbestos.
  • Talc, a naturally occurring mineral, is used in many cosmetic products, and there are concerns regarding the potential for contamination of talc with asbestos, a known carcinogen. Thus, in 2018 FDA formed the Interagency Working Group on Asbestos in Consumer Products to develop recommendations and standardized testing methods for asbestos and other mineral particles of concern in talc.
  • The first sampling assignment was completed in 2019.  The results of the 2019 sampling assignment showed that 43 samples were negative and 9 were positive for the presence of asbestos. These findings resulted in recalls and FDA advisories, warning consumers not to use the cosmetics  that had tested positive for asbestos.
  • FDA will conduct another talc sampling assignment in 2022, with 50 additional talc-containing cosmetic product samples. The final results are expected to be released next year.
  •  Many of our readers will recall a February 4, 2021 report by the U.S. House of Representatives subcommittee on Economic and Consumer Policy (summarized here) that raised alarm regarding the levels of heavy metals— including arsenic, lead, cadmium, and mercury— reportedly found in baby foods produced by seven of the largest baby food manufacturers in the U.S.  The Food and Drug Administration (FDA) issued a response on February 16, 2021, as discussed here, outlining the current regulatory activities for assuring that naturally occurring toxic elements in many crops do not reach dangerous levels in food.  Soon after, on March 5, 2021, FDA announced new activities, including a letter to baby food manufactures, increased sampling and other plans (as discussed here) that target reducing the levels of toxic elements in baby food.  On April 8, 2021, FDA released a new Closer to Zero action plan involving four stages: (1) Evaluate the science, (2) Propose action levels, (3) Consult with stakeholders, and (4) Finalize action levels for lead, arsenic, cadmium, and mercury.  As discussed here, FDA’s Closer to Zero action plan is scheduled to unfold in phases over several years, with the first phase (proposing action levels for lead in various categories of baby foods) scheduled for completion by April 2022.
  • On September 29, 2021, just seven months after its initial report, the same congressional subcommittee released a new report that adds test results the authors deem concerning for some Plum Organics and Sprout products (not reviewed in the first report), and new information from Walmart (also not discussed in the first report) which the authors characterize as showing a decrease in protective standards.  Summaries of the companies’ responses to the report’s claims are available here.
  • Recommendations in the new report, which is critical of all baby food manufacturers’ handling of toxic elements, as well as FDA’s timeline for publishing draft and final limits for lead, arsenic, cadmium, and mercury in baby foods, include:
    • For FDA to accelerate its proposed timelines for publishing final limits for toxic heavy metals and require baby food manufacturers to test their finished products, and
    • For industry to voluntarily adopt finished product testing, rather than attempt to control levels of heavy metals “based on inaccurate individual-ingredient tests,” and to use appropriate substitutes or phase out products that have high amounts of ingredients that frequently test high in toxic heavy metals, such as rice.
  • Keller and Heckman will continue to monitor and report on FDA’s regulatory activities, as well as congressional investigation and litigation involving heavy metals in baby food.