INSIGHTS
January 4, 2023
Kicking off the New Year with New FDA Happenings
With fresh snow and the start of a new year comes new FDA happenings. While most of the country was occupied by delayed flights and snowstorms, FDA and Congress made several noteworthy announcements that we flag here to bring you up to speed
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- On December 23, 2022, Congress passed the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), which includes (under Subtitle E), the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), primarily focused on cosmetic safety. As discussed in our previous post here, MOCRA amendments to the Federal Food, Drug & Cosmetic Act represent the first statutory change to FDA’s cosmetic authority in more than 80 years!
With the new legislation, FDA will develop and issue good manufacturing practice regulations for cosmetics and create tests for asbestos. FDA will also require that cosmetic facilities register and list, report adverse events, and maintain records to substantiate the safety of products. FDA will also for the first time have mandatory recall authority over cosmetics where there is a reasonable probability that a cosmetic has been adulterated or misbranded and could result in health consequences. While MOCRA preempts state law requirements that differ from these requirements, state laws that prohibit and limit the use or amount of an ingredient in a cosmetic product, and state laws and referendums such as California’s Proposition 65, are carved out from preemption. Although the new requirements will become effective one year after the legislation’s enactment, and there will be time to come for industry to come into compliance, the passage of MOCRA represents a significant step forward for cosmetic reform.
- On December 23, 2022, Congress passed the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), which includes (under Subtitle E), the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), primarily focused on cosmetic safety. As discussed in our previous post here, MOCRA amendments to the Federal Food, Drug & Cosmetic Act represent the first statutory change to FDA’s cosmetic authority in more than 80 years!
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- On December 28, 2022, FDA issued the 2022 edition of the FDA Food Code. The 2022 Food Code provides a uniform set of national standards for the safety and protection of food offered at retail and in food service, and is intended to be a model for adoption by state, local, tribal and territorial regulatory bodies. For the first time, the 2022 Food Code specifically addresses food donations as part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition and Health, clarifying that food which is stored, prepared, packaged, displayed and labeled according to the code’s safety provisions, can be donated.
Additionally and significantly, the Food Code adds sesame as a major food allergen, consistent with the Food Allergy Safety, Treatment, Education and Research (FASTER) Act, which established sesame as the 9th major food allergen, effective January 1, 2023.
The 2022 Food Code also provides guidance on providing written notice to consumers of major food allergens in unpackaged food.
- On December 28, 2022, FDA issued the 2022 edition of the FDA Food Code. The 2022 Food Code provides a uniform set of national standards for the safety and protection of food offered at retail and in food service, and is intended to be a model for adoption by state, local, tribal and territorial regulatory bodies. For the first time, the 2022 Food Code specifically addresses food donations as part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition and Health, clarifying that food which is stored, prepared, packaged, displayed and labeled according to the code’s safety provisions, can be donated.
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- FDA issued several Warning Letters for various violations including: adulterated active pharmaceutical ingredients containing impurities at unacceptable levels (WL issued to failure to Superior Glove Works, 01/03/2023); unlawful sale of unapproved and misbranded drugs to U.S. consumers over the internet (WL issued to Global Pharmacy Plus, 01/03/2023); failure to comply with GMP and Preventive Controls regulations for ready-to-eat ice cream products and attributing L. monocytogenes outbreak to facility (WL issued to Big Olaf Creamery, 12/27/2022); failure to develop and maintain a Foreign Supplier Verification Program (FSVP) (WL issued to Supreme Fruit Produce, 12/27/2022), deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) (WL issued to MD Pharmaceutical Supply, 12/27/2022), violations of GMPs and Risk-Based Preventive Controls for Animal Foods causing medicated feed to be adulterated (WL issued to Land View, 12/27/2022).
- FDA issued several Warning Letters for various violations including: adulterated active pharmaceutical ingredients containing impurities at unacceptable levels (WL issued to failure to Superior Glove Works, 01/03/2023); unlawful sale of unapproved and misbranded drugs to U.S. consumers over the internet (WL issued to Global Pharmacy Plus, 01/03/2023); failure to comply with GMP and Preventive Controls regulations for ready-to-eat ice cream products and attributing L. monocytogenes outbreak to facility (WL issued to Big Olaf Creamery, 12/27/2022); failure to develop and maintain a Foreign Supplier Verification Program (FSVP) (WL issued to Supreme Fruit Produce, 12/27/2022), deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) (WL issued to MD Pharmaceutical Supply, 12/27/2022), violations of GMPs and Risk-Based Preventive Controls for Animal Foods causing medicated feed to be adulterated (WL issued to Land View, 12/27/2022).
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- FDA announced several voluntary recalls, including Easy Care First Aid® Burn Cream and First Aid Kits due to microbial contamination, Avery’s Savory Popcorn due to undeclared milk and tree nut product allergens, Caesar’s Pasta’s frozen manicotti due to potential L. monocytogenes contamination, SunSprout Enterprises’ alfalfa sprouts due to potential contamination with salmonella, Garden of Light’s Oat & Honey Organic Granola due to potential almond contamination, and Melissa’s Pasta due to undeclared wheat allergens. As the leading cause of food recalls in the U.S. is the presence of undeclared allergens, we strongly recommend review of product labeling and formulations to ensure compliance.
- FDA announced several voluntary recalls, including Easy Care First Aid® Burn Cream and First Aid Kits due to microbial contamination, Avery’s Savory Popcorn due to undeclared milk and tree nut product allergens, Caesar’s Pasta’s frozen manicotti due to potential L. monocytogenes contamination, SunSprout Enterprises’ alfalfa sprouts due to potential contamination with salmonella, Garden of Light’s Oat & Honey Organic Granola due to potential almond contamination, and Melissa’s Pasta due to undeclared wheat allergens. As the leading cause of food recalls in the U.S. is the presence of undeclared allergens, we strongly recommend review of product labeling and formulations to ensure compliance.
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- FDA’s VQIP Application Portal is now open (as of January 1, 2023) for benefits during fiscal year (FY) 2024. VQIP is a voluntary fee-based “trusted trader” program that provides approved importers, who achieve and maintain control over the safety and security of their supply chains, the benefits of expedited review and fast-track importation of human and animal foods into the U.S.