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  • On June 15, 2023, FDA released its findings from a sampling assignment that collected and tested 747 refrigerated ready-to-eat (RTE) dips for the presence of Listeria monocytogenes and Salmonella spp. The Agency detected Listeria monocytogenes in three dip and cheese spread samples, and Salmonella spp. in one hummus sample.
  • This assignment is part of FDA’s risk-based approach to food safety outlined in the Food Safety and Modernization Act (FSMA) and was conducted in response to previous outbreaks in 2017 and 2019 that may have contributed to three deaths. The Agency noted the increased consumer consumption of RTE dips and spreads, their susceptibility to bacteria growth due to ideal pH and water activity levels, and consumption without a “kill step” (e.g., cooking, frying, pasteurization, etc.) contribute to the significant public health risk of such products.  
  • FDA specifically indicated all three Listeria monocytogenes contaminated products originated from the same manufacturer due to the absence of effective sanitation controls. The Agency recalled such products and underscored the benefits of adhering to good manufacturing practices (GMPs) and implementing preventative controls. FDA is reviewing the results of the assignment to identify common factors or patterns related to contamination of RTE dips and spreads, develop guidance, and update program priorities.
  • Keller and Heckman will continue to monitor developments in this space.
  • On Tuesday, June 13, 2023, the House Judiciary Subcommittee held a hearing titled: “Where’s the Beef? Regulatory Barriers to Entry and Competition in Meat Processing” to examine how various aspects of government regulation may impede the development of a more competitive meat industry.  The subcommittee explored the potential impact on competition, should smaller entrants be subjected to less onerous food inspection requirements and be permitted to sell state-inspected meat across state lines.
  • As our readers recall, the spread of COVID-19 closed many meat and poultry processing facilities.  However, in 2022, the U.S. Department of Agriculture (USDA) made available $215 million in grants and other support to promote the competition, accessibility, and expansion of the meat and poultry industry, especially in rural America.  However, the three farmers who testified at Tuesday’s hearing alleged that certain regulations and USDA’s  inspection requirements tend to disadvantage smaller processing businesses.  The farmers urged the subcommittee to allow small operators to forego certain federal inspection regulations.
  • At this time, 21 U.S.C. § 623(a) only exempts custom slaughterhouses from inspections but only if the meat is for personal, household, guest, or employee use. 
  • On April 25, 2023, Thomas Massie, R-KY, and Chellie Pingree, D-ME reintroduced the Processing Revival and Intrastate Meat Act (PRIME). The PRIME Act exempts custom slaughter facilities from animal slaughter and carcass preparation inspections, regardless of use.  In the Senate, Angus King, I-ME, and Rand Paul, R-KY, introduced the companion legislation, PRIME, on March 22, 2023. Massie and Pingree urged members to adopt this legislation at the Tuesday meeting.
  • Keller and Heckman will continue to monitor and relay any changes in meat and poultry regulations.
  • On June 1, a group of bipartisan lawmakers led by Senator Mike Lee, R-UT, introduced the Formula 3.0 Act which would permanently remove tariffs and other trade restrictions on imported infant formula base powder. This bill follows the expiration of the Formula Act, an emergency measure signed into law by President Biden in July 2022 that temporarily removed tariffs on infant formula in response to the nationwide infant formula shortage. Proponents of the bill said the Formula 3.0 Act aims to address vulnerabilities in the domestic infant formula market highlighted by the shortage last year.
  • As our readers likely recall, FDA issued a recall of powdered infant formula originating from Abbott Nutrition’s facility in Sturgis, Michigan in February 2022. At the time, the Abbott facility supplied 40% of the nation’s infant formula. The recall and subsequent shutdown of the facility resulted in a monthslong infant formula supply shortage which drew attention to vulnerabilities in the domestic supply and to high tariffs and other obstacles imposed on imported infant formula.
  • According to a 2022 report from the Congressional Research Service, imports of infant formula have increased substantially over the last decade, accounting for approximately 4.3 million kilograms (valued at $28.8 million) of domestic consumption in 2021. The most-favored-nation (MFN) tariff rate for these products typically ranges from 14.9% to 17.5%. Though tariffs were temporarily waived by the emergency measures enacted in July 2022, these measures have since expired.
  • Keller and Heckman will continue to monitor developments on issues pertaining to infant formula.
  • The U.S. Food and Drug Administration (FDA) and the Center for Disease Control and Prevention (CDC) are renewing public health warnings that address the continuing hepatitis A outbreak traced to frozen, organic strawberries.  Although the outbreak has progressed slowly, public health officials are concerned that consumers may continue to be at risk due to the frozen product’s long shelf life.
  • As the FDA and CDC continue to investigate, various retailers have voluntarily recalled products that may be contaminated.  The strawberries in question have been found to have been imported by a common supplier from certain farms located in Baja California, Mexico.  FDA reported that, “the strain of hepatitis A virus causing illnesses this year is genetically identical to the strain that caused the outbreak of hepatitis A virus infections in 2022, which was linked to fresh organic strawberries imported from Baja California, Mexico, and sold at various retailers.”
  • Hepatitis A is a highly contagious, vaccine-preventable, liver infection caused by the Hepatitis A Virus (HAV).  Even if no symptoms are present, people can still transmit the infection.  Thus far, there have been 18 reported cases, resulting in 13 hospitalizations.  FDA has provided general food safety tips for consumers and retailers during an outbreak.
  • On April 26, House Energy Commerce Committee Member Pallone (D-NJ) and Senator Blumenthal (D-CT) introduced the Food Labeling Modernization Act of 2023 (FLMA). The bill would update front-of-package food labeling requirements, require updates to the ingredient list on packaged foods, and apply consumer friendly labeling requirements. As our readers may recall, a similar bill was introduced in the House in 2021.
  • FLMA’s initiative would direct FDA to establish a standard front-of-package nutrition labeling system for all of the packaged foods it regulates to complement the Nutrition Facts panel and clearly convey when high levels of sodium, added sugar, or saturated fat are present in foods. As reported by the Center for Science in the Public Interest, similar requirements have already been implemented in several countries, including Canada, Ecuador, and Chile.
  • FLMA would amend “standards of identity” to allow salt substitution across all packaged foods, which purportedly would enable the food industry to contribute to a national sodium reduction effort by swapping out sodium from standardized foods. FLMA would also update the labeling laws to require that the same Nutrition Facts, ingredient, and allergen information now on packages be available for online grocery items.
  • Further, FLMA includes several provisions aimed at addressing supposedly misleading claims that undermine health, such as whole grain, fruit, and vegetable claims. FLMA would additionally require clear disclosure for certain ingredients of public health importance such as caffeine in excess of 10mg per serving and gluten-containing grains.
  • Keller and Heckman will continue to monitor the status of FLMA and report with updates as they arise.
  • Today, FDA announced that it will be holding a virtual listening session on June 1, 2023 for interested parties to consult cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations, and other experts to help inform FDA’s efforts in developing regulations to establish good manufacturing practices (GMPs) for facilities that manufacture, or process cosmetic products distributed in the United States.
  • The event will include preliminary introductions and brief remarks on cosmetic product GMPs, followed by public comments on cosmetic GMPs.
  • To facilitate the discussion, FDA has developed topics covering the types of information the Agency seeks to obtain from industry, including:
    • Cosmetic GMPs
      • Identify any national or international standard and the extent to which it would be practicable for GMP regulations for cosmetic products;
      • Describe what constitutes sufficient flexibility within GMPs for cosmetic products to ensure regulations are practicable for all sizes and types of facilities;
      • Describe what constitutes simplified GMPs requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship; [and]
      • Describe appropriate compliance times for GMP regulations.
    • GMP Economic Impact
      • To what extent are manufacturers of cosmetic products already following a national or international standard for GMPs?  If an entity is not currently following a standard, what would the cost to implement GMPs consistent with such standard be?
      • Provide reports or examples of adverse events or recalls associated with a cosmetic product that were linked to manufacturing practices. How would implementing GMPs impact the likelihood of a recall of cosmetics products?  How would implementing GMPs impact the likelihood of consumers experiencing adverse events from the use of cosmetics products?  How would these impacts differ by type of cosmetic product?
  • Interested parties may register for the event at this link. The session will take place on June 1, 2023 from 10AM- 1PM EST.
  • Keller and Heckman will continue to monitor and report on FDA activity impacting the cosmetic industry.
  • FDA regulates human and animal food from plants, including plants produced through genetic engineering (GE), under the Federal, Food, Drug, and Cosmetic Act (FD&C Act).  Foods derived from new plant varieties, both GE plants as well as varieties from traditional plant breeding, must meet the same FDA regulatory requirements that apply to all foods.  FDA has established a voluntary Plant Biotechnology Consultation Program whereby companies may submit notices, which FDA reviews and responds to with respect to whether food derived from a new plant variety presents safety and regulatory issues.  One of the factors that FDA considers is whether a protein expressed by a new plant variety may cause an allergic reaction because adverse reactions to food allergens can be severe and life-threatening, including when the allergen is present at low levels. 
  • In an April 13, 2023 Constituent Update, FDA announced that a letter was sent to manufacturers and developers of new plant varieties who intend to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens) into new plant varieties used for food.  FDA cautions these developers to consider the food safety risks posed by such allergens and plan early in development to manage the risks.  Although meat is not a major allergen, plant-based proteins made by adding a gene for an allergenic animal protein to a new plant variety are called out in FDA’s letter as an example of GE that could result in the presence of an unexpected allergen in another food made with a new plant variety as an ingredient.  The only other cautionary example provided in FDA’s letter is the historical case of a Brazil nut gene that was transferred into a soy variety to improve its nutritional profile for animal feed, in which case development was voluntarily discontinued based on the developers’ concerns that they could not ensure the modified soybean would not inadvertently get into human food.  In this regard, FDA’s letter reminds developers to consider allergenicity issues related to their products, and how they would be stewarded from production to manufacturing to consumption so that they do not inadvertently or unexpectedly enter the food supply and how their products need to be properly labeled when intentionally part of the food supply.  FDA’s letter also cautions that if unexpected and unlabeled allergens enter the food supply, this could have other consequences for food producers, such as needing to recall the affected products.
  • FDA’s letter does not explain how the presence of an allergen is likely to be “unexpected and unlabeled” in the case of proteins from new plant varieties that are being developed as plant-based substitutes for animal proteins, such as collagen, myoglobin, ovalbumin or casein that are used in currently marketed foods containing these proteins.  The larger issue would seem to be unintended spread of a gene for an allergenic protein to non-GE crops.  For example, we have discussed how genetic material from two new GE varieties of canola seed was found in specific lots of non-GE canola seed and a small number of non-GE canola fields before voluntary premarket consultations with FDA for the GE canola were completed.  In this case, new proteins expressed in the canola were found unlikely to be allergenic and the issue of preventing unintended spread to non-GE crops (which is in the jurisdiction of USDA’s Animal and Plant Health Inspection Service (APHIS)), was not addressed in FDA’s favorable response letters on the GE canola.
  • On March 21, the FDA released Activities for the Safety of Imported Seafood, a report which details the approach the Agency’s is taking to ensure that imported seafood consumed in the U.S. meets food safety requirements and the standards of domestically produced seafood. For background on the FDA’s “Strategy for the Safety of Imported Food,” see our February 2019 blog and September 2022 blog regarding FDA’s report for imported produce. 
  • The reports details how established FDA regulation and innovative programs and technology are employed to support each of the four goals that were established in the 2019 strategy document as they relate to imported seafood safety:
    • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements
      • FDA objectives include relying on international inspections, using verified foreign suppliers, auditing such as those conducted under FDA’s Accredited Third-Party Certification Program or other programs aligned with FDA produce safety requirements, incentivizing importers to use verified suppliers through the Voluntary Qualified Importer Program (VQIP), leveraging oversight efforts of regulatory counterparts with strong food safety systems, and increasing awareness and training of seafood safety requirements.
    • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods
      • FDA objectives include enhancing and refining FDA’s import screening and entry review process, optimizing use of sampling of imported seafood, utilizing import alerts and import certifications, improving testing methods and tools to determine admissibility of seafood offered for import, and maximizing surveillance from state and other partnerships.
    • Goal 3 – Rapid and Effective Response to Unsafe Imported Food
      • FDA objectives include maximizing the effectiveness of Agency responses to events involving imported seafood, such as recalls.
    • Goal 4 – Effective and Efficient Food Import Program
      • FDA objectives include a better understanding of the global inventory of seafood facilities and farms and conduction of performance assessments of the effectiveness of import activities.
  • Keller and Heckman will continue to monitor and report on any developments that impact seafood safety requirements.
  • Yesterday, on March 8, 2023, the U.S. Food and Drug Administration (FDA) sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula, asking for them to share current safety information and to take action to improve processes for the protection of infants.
  • Last year, safety concerns at one of the largest infant formula manufacturing facilities in the U.S. prompted a nationwide recall and temporary pause in production, leading to a national infant formula shortage.  Since then, FDA has issued multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula through enforcement discretion.  The Agency has also developed a cronobacter prevention strategy, enhanced inspection activities, increased engagement with the industry, and has pursued regulatory action in some cases.
  • In the recent months, FDA food safety staff have been meeting regularly with the powdered infant formula manufacturers to further develop the prevention strategy to help prevent cronobacter illness.  The letter reflects the information gained during these meetings, as well as the latest available science.
  • In its update, FDA calls on all members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for infant protection.  FDA will continue to inspect and work with the industry to advance research and regulatory activities included in the prevention strategy.
  • Keller and Heckman will continue to monitor and report on any developments in this area.
  • We have previously discussed a series developed by FDA last year of Prevention Strategies to Enhance Food Safety.  Prevention Strategy documents contain recommendations for the prevention of future foodborne illness for food-hazard pairings where emerging patterns can be identified and targeted.  The first two Prevention Strategy documents were: (1) Bulb Onion Strategy Document (July 2022) targeting Salmonella contamination of bulb onions, and (2) Imported Enoki and Imported Wood Ear Mushroom Strategy Document (September 2022) targeting Listeria monocytogenes and Salmonella contamination of imported specialty mushrooms. 
  • A third Prevention Strategy document has since been released.  Powdered Infant Formula Strategy Outline (November 2022) targets the prevention of Cronobacter sakazaki illnesses associated with consumption of powdered infant formula, and seeks to:
    • Broaden scientific knowledge and understanding of Cronobacter sakazakii and public health interventions for controlling it;
    • Improve oversight of safe production of powdered infant formula; and
    • Enhance communications and engagement with industry, consumers, federal, state, local, and other public health partners about infant formula safety. 
  • FDA’s Prevention Strategy Documents table will likely soon be updated again to add an additional resource for enoki mushrooms.  Specifically, on March 1, 2023, FDA announced the expansion of a country wide import alert (IA) for enoki mushrooms from the Republic of Korea, noted earlier as a resource for the Prevention Strategy document, to also cover enoki mushrooms from China.  The expanded IA #25-21 “Detention Without Physical Examination of Enoki Mushrooms from the Republic of Korea and China due to Listeria Monocytogenes” follows multiple recalls linked to contaminated enoki mushrooms from China and a recent FDA multi-state outbreak investigation that linked three cases of listeriosis to enoki mushrooms labeled as a product of China.