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 December that should be highlighted. 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)
- On December 13, 2023, FDA confirmed the effective date of December 22, 2023, for the direct final rule regarding the revocation of uses of partially hydrogenated oils (PHOs) in food. The FDA had previously said that this would be the effective date unless it received any significant adverse comments during the comment period. FDA indicates it did not receive any significant adverse comments. The Final Rule was published on August 9, 2023.
- On December 14, 2023, FDA published a notice on“Menu Labeling: Supplemental Guidance for Industry (Edition 2)” that proposes revisions and additional questions and answers to the current guidance on Menu Labeling: Supplemental Guidance for Industry (May 2018). When finalized, the Draft Guidance would reflect FDA’s current thinking on these areas of menu nutrition labeling and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
- This month, it was reported that FDA product recalls have seen a significant spike over the past several years.
United States Department of Agriculture (USDA)
- On December 4, 2023, USDA’s Food Safety and Inspection Service (FSIS) reissued FSIS Directive 7160.3 (Revision 3), “Verification Activities for Advanced Meat Recovery Systems.” The Directive updates and provides instructions to Inspection Program Personnel (IPP) in establishments using advanced meat recovery (AMR) systems, by incorporating instructions from previous, and now cancelled directives.
- On December 19, 2023, FSIS issued FSIS Directive 8080.1, Revision 8, “Managing Adulterated or Misbranded Meat, Poultry, and Egg Products.” The Directive includes instructions for FSIS inspectors on terminology, agency responsibilities, and public notification procedures for recalls of FSIS-inspected products. The Directive also provides industry guidance for the development of recall plans for meat, poultry, and egg products.
- On December 22, 2023, FSIS published a Notice entitled “2024 Rate Changes for the Basetime, Overtime, Holiday, Laboratory Services, and Export Application Fees.” The Notice announces the 2024 rates FSIS will charge meat and poultry establishments, egg products plants, and importers and exporters for providing voluntary, overtime, and holiday inspection and identification, certification, and laboratory services.
Other
- On December 6, 2023, both USDA and the U.S. Department of Health and Human Services (HHS), which includes FDA, released their Fall 2023, Unified Agenda of Regulatory and Deregulatory Actions, commonly known as the “Regulatory Agenda.”
- Cosmetics – On December 20, 2023, FDA’s Office of the Chief Scientist (OCS) introduced new proposed guidance documents under development. Over the years, OCS has issued a number of guidance on cosmetics.
- Registration and Listing of Cosmetic Product Facilities and Products;
- Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination;
- Mandatory Recalls (to be developed in collaboration with other FDA agencies); and
- Records Access (to be developed in collaboration with other FDA agencies)
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Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
