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 January 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 January 10, 2023, the FDA published the final guidance entitled, “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry.” The Guidance provides the agency’s thinking on how importers of food for humans and animals can comply with the Foreign Supplier Verification Program (FSVP) regulations.
- On January 24, 2023, the FDA published the Draft Guidance, “Action Levels for Lead in Food Intended for Babies and Young Children.” This Draft Guidance is part of the FDA’s “Closer to Zero” Action Plan and is meant to provide information to the industry on the action levels for lead in “processed food” intended for babies and young children less than two years old. The Action Levels are as follows:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
- 20 ppb for root vegetables (single ingredient); and
- 20 ppb for dry infant cereals.
- On January 26, 2023, the FDA announced its conclusion “that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol,” and the agency will “work with Congress on a new way forward.” OFW Law did a blog post when the announcement was made (here).
- On January 26, 2023, the FDA published an Agency Information Collection in the Federal Register entitled, “Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Research on Front of Package Labeling on Packaged Foods.” This Information Collection shares FDA’s intent to conduct an experimental study, informed by the results of focus group testing, to further explore consumer response to various front-of-pack (FOP) labeling schemes. The FDA requests comments on its estimate of burden per the Paperwork Reduction Act. Comments on the FOP Information Collection are due on or before March 27, 2023.
- On January 31, 2023, FDA Commissioner Dr. Robert Califf announced a “new, transformative vision” to comprise FDA’s “human foods program” including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), and relevant parts of the Office of Regulatory Affairs (ORA). Commissioner Califf also announced a new vision for ORA (FDA’s field-based operations), outside of the Human Foods Program to support the FDA.
United States Department of Agriculture (USDA)
- On January 13, 2023, USDA’s Food Safety and Inspection Service (FSIS) published the FSIS 2023-2026 Strategic Plan. The Strategic Plan includes key efforts the agency plans to engage in, including:
- Focusing on reducing illness from meat, poultry, and egg products (in particular, the agency continues to focus on retooling its strategy to reduce Salmonella illnesses attributable to poultry);
- Further enhancing the FSIS inspection systems;
- Ensuring compliance with food safety regulations; and
- Prioritizing recruiting and retaining a diverse array of employees.
- On January 17, 2023, FSIS published a Final Rule that expands the scope of meat, poultry, and egg product labels and label claims that can be generically approved. These situations include labels:
- For products for export only that deviate from FSIS requirements;
- Ingredients in ingredient declarations that are certified as “organic”;
- Geographic claims (e.g., flag, monument, landmarks);
- “Negative” claims to identify the absence of certain ingredients or types of ingredients; and
- Products that receive voluntary FSIS inspection.
- There are two (2) USDA pending proposals currently under review by the U.S. Office of Management and Budget (OMB). These rules, which will be published shortly, are:
- Proposed Rule on “Product of the U.S.” labeling claims: Under current FSIS policy, products with a “Product of the U.S.” or similar claim, must at a minimum, have been processed in the U.S. After a comprehensive consumer and industry review of the claim, FSIS is changing the requirements.
- A Notice on Salmonella as an adulterant in breaded and raw stuffed chicken products. FSIS intends to declare Salmonella an adulterant in these products (i.e., subject to enforcement and recalls.
Other
- On December 20, 2023, the U.S. Federal Trade Commission (FTC) published a regulatory review; request for public comment on “Guides for the Use of Environmental Marketing Claims ” (FTC Green Guides). The FTC is soliciting comments about the efficiency, costs, benefits, and regulatory impact of the FTC Green Guides to determine whether to retain, modify, or rescind them. The FTC Green Guides impact how food and agricultural companies market their products. Comments on the FTC Green Guides are due on or before February 21, 2023.
- On January 4, 2023, the Office of Management and Budget (OMB) released the Semiannual Regulatory Agendas for Fall 2022. All Federal Agency Regulatory Agendas can be found here.
- The development process for the 2025-230 Dietary Guidelines for Americans (DGA) is underway. On January 19, 2023, the Department of Health and Human Services (HHS) and USDA announced the appointment of twenty (20) committee members. The first meetings of the Advisory Committee are scheduled for February 9 and 10. According to the Federal Register notice, the first meeting agenda will include (a) a review of operations for the Committee members, (b) an overview of the proposed scientific questions identified by the Departments to be examined by the Committee, (c) presentations on the evidence-based approaches for reviewing the scientific evidence, and (d) plans for future Committee work.
