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Proposed Legislation Would Lock-In USDA’s Oversight of Cell-Based Meat

  • As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) have issued a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be found here).  The agreement provides helpful answers regarding many regulatory aspects of the cell-cultured food industry, including the expected inspectional burdens for cell-based meat and poultry.  The formal agreement between FDA and USDA, however, does not permanently bind either Agency as it could be revised as needed based on experience or funding considerations going forward.

  • The Cell-Cultured Meat & Poultry Regulation Act of 2019 (S.1056), which was introduced last week by Senator Cindy Hyde-Smith (R, Mississippi), would amend the Federal Meat Inspection Act and the Poultry Products Inspection Act to formally and more permanently place regulation, inspection, and labeling of cell-cultured meat and poultry under FSIS jurisdiction.  If the proposed legislation is enacted, FSIS and FDA will be required to issue final regulations within 18 months: (1) that prescribe the type and frequency of inspection required for the manufacture and processing of food products; and (2) for the prevention of the adulteration and misbranding of food products.  With respect to labeling, the federal law contains language that could potentially make it easier for cell-based meat products to be called “meat” or “poultry” and it would preempt state laws that restrict the definitions of meat, poultry, chicken, etc. to potentially exclude cell-cultured meat products (see our blog post on the recently-passed Arkansas law).

  • The bill was referred to the Senate Agriculture Committee for consideration, but the likelihood of passage is unclear.  We will continue to track the regulation of cell-cultured food.  

© 2020 Keller and Heckman LLP


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...