OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from May that we took note of. If you have any questions or would like more information, please do not hesitate to reach out to us.
U.S. Food and Drug Administration (FDA)
- Infant formula shortage: Various factors, including a large-scale infant formula recall, supply-chain issues due to the COVID-19 pandemic, and trade policy barriers, led to a massive shortage in infant formula. On May 18, 2022, FDA released a guidance for industry to help increase the supply of infant formula in the U.S. through an Enforcement Discretion Policy. FDA also released a statement on increasing the supply of specialized medical infant formula. Meanwhile, the FTC launched an inquiry into the nature and prevalence of unfair business practices aimed at taking advantage of families during the shortage. USDA also urged states to take advantage of flexibilities offered in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), the help families access formula.
- On May 9, 2022, multiple warning letters were posted by FDA that were sent to companies for among other things, selling adulterated dietary supplements that contain new dietary ingredients (NDIs) for which FDA has not received the require premarket NDI notifications, unsafe food additives, or are drugs despite lack of approval.
- On May 20, 2022, the FDA final rule amended the food additives regulations to no longer provide for the use of 23 phthalates (a group of chemicals used in plastics to support durability) and two other substances used in plastic, in food contact applications because they have been abandoned by industry.
- FDA sent warning letters to four companies for illegally selling cannabidiol (CBD) products intended for use in food-producing animals. To date, there is not enough data to understand the impact of food-producing animals consuming CBD and the potential risks to humans and animals.
United States Department of Agriculture (USDA)
- On May 26, 2022, USDA announced a proposed rule, Transparency in Poultry Grower Contracting and Tournaments, under the Packers and Stockyards Act. USDA believes the proposed rule will promote transparency in poultry production contracting and give current and potential poultry growers the relevant information they need to make business decisions. The proposed rule, among other things, will require poultry processors to provide key and more robust information to poultry growers at several critical steps.
- On May 23 and May 24, 2022, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) hosted two identical webinars on the revised 2021 Cooking Guideline for Meat and Poultry Products (Revised Appendix A) and 2021 Stabilization Guideline for Meat and Poultry Products (Revised Appendix B) that were announced on December 14, 2021, in the Federal Register. Establishments that used previous versions of the Appendices have until December 14, 2022, to either update to the 2021 guidelines or identify alternative support
- To increase data transparency and access to agency-generated data, FSIS is preparing to expand the establishment-specific datasets on laboratory sampling results to include the FSIS Number – a whole-genome sequence (WGS) identifier assigned for pathogens – and allele codes with date stamps for Listeria monocytogenes, Salmonella, and Shiga toxin-producing Escherichia coli (E. coli). Prior to publishing, FSIS seeks comments on the sample dataset and data documentation.
- On May 26, 2022, the U.S. Department of Health and Human Services (HHS) issued a Final Rule in the Federal Register that withdraws a January 2021, Trump Administration rule on “Securing Updated and Necessary Statutory Evaluations Timely” (Sunset Rule), which would have “sunset” HHS (including agencies under HHS, e.g., FDA) rules if certain conditions were not met.