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 significant developments from July. 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 July 2, 2024, FDA announced that starting August 2, 2024, it is revoking the regulation authorizing the use of brominated vegetable oil (BVO) in food. Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine. The agency concluded that the intended use of BVO in food is no longer considered safe.
- On July 16, 2024, FDA’s final rule, “Nutrient Content Claims, Definition of Term: Healthy,” was sent to the Office of Management and Budget (OMB) for review. After being reviewed by OMB, the time it takes for the final rule to be published may vary depending on factors (i.e., the complexity of the rule and any additional revisions needed by FDA).
- On July 30, 2024, FDA announced several FY 2025 annual fee rates that will be effective on August 1, 2024, for the following:
- Importers approved to participate in the Voluntary Qualified Importer Program (VQIP) (here);
- Recognized accreditation bodies and accredited certification bodies, as well as the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program (here);
- Certain domestic and foreign facilities reinspection, failure to comply with a recall order, and importers’ reinspection (here).
United States Department of Agriculture (USDA)
- On July 19, 2024, USDA’s Food Safety and Inspection Service (FSIS) announced forthcoming implementation of a new Allergen Verification Sampling Program at establishments that produce ready-to-eat (RTE) products with negative labeling claims for 14 total food allergens (soy, crustacean, shellfish, eggs, peanuts, milk, eight tree nuts (almonds, Brazil nut, cashew, coconut, hazelnut, macadamia, pine nut, and walnut) as well as gluten. In the future, FSIS plans to include an analysis of sesame. The initial implementation date was August 1, 2024, but was pushed until September 1, 2024. As part of this, the agency also issued two new directives related to the new sampling program:
- FSIS Directive 7000.5: “FSIS Sampling for Labeling Claims Verification,” provides instructions to inspection program personnel (IPP) on labeling claims verification sampling at establishments that produce products in consumer-ready packaging bearing certain labeling claims or a nutrition facts panel per eligibility criteria.
- FSIS Directive 7000.6: “Allergen Verification Sampling Program,” provides instructions to IPP to collect samples for the allergen verification sampling program conducted at establishments that RTE products with labeling claims for 14 food allergens and gluten.
- On July 29, 2024, the USDA’s Food Safety and Inspection Service (FSIS) released an advance copy of its proposed rule and proposed determination, “Salmonella Framework for Raw Poultry Products.” If finalized, this would set product standards for raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products, deeming those that violate these standards to be “adulterated” under the Poultry Products Inspection Act (PPIA). The Framework also aims to amend FSIS regulations to tackle Salmonella contamination during slaughter and dressing operations. Similar to the 2022 Draft Salmonella Framework, this includes three components: (1) pre-harvest measures, (2) enhanced establishment process controls, and (3) proposed final product standards, which are briefly summarized below.
***
Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
