On June 21, 2023, UPSIDE Foods and GOOD Meat received final approvals by the U.S. Department of Agriculture (USDA) for the sale of cell-cultivated chicken in the United States. This marked the first approvals of cultivated meat products in the U.S. and a turning point for the industry. The Food and Drug Administration (FDA) worked with the USDA to complete a joint review process that was initially outlined in March 2019. The announcement of these approvals was preceded by the successful conclusion of premarket consultation processes by the FDA (the "no questions" letters), USDA facility approvals, and USDA label approvals in spring 2023.
The partnership between the FDA and USDA in regulating cultivated meat is based on their traditional areas of oversight for food and feed production. These agencies hosted a webinar in 2020 to outline the rationale and plans for joint regulatory oversight: FDA and USDA Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products - YouTube.
Regulatory oversight for U.S. cultivated meat products occurs as follows:
- FDA oversees cell collection, cell banks, and cell growth and differentiation for all types of cultivated meat.
- FDA transfers oversight to the USDA at the stage of "harvesting" for cultured meat products that fall under the authority of the Federal Meat Inspection Act (FMIA) (cattle, sheep, swine, goats, and Siluriformes fish) or the Poultry Products Inspection Act (PPIA) (chicken, turkeys, duck, geese, guineas, ratites, and squab). USDA Food Safety and Inspection Service (FSIS) oversees downstream processing and labeling for these types of cultivated meat.
- All other types of animal cell cultures fall under the FDA's regulatory authority for processing and labeling via the Federal Food, Drug, and Cosmetic Act (FFDCA) and Public Health Service Act.
More details may be found on the FDA webpage Food Made with Cultured Animal Cells.
Related Resources
- June 21, 2023 - "'No kill' meat, grown from animal cells, is now approved for sale in the U.S." (All Things Considered, 3-min NPR segment by Allison Aubrey)
- March 21, 2023 - FDA Completes Second Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology Before Entering the U.S. Market, the Food Must Meet Federal Requirements
- November 16, 2022 - FDA Completes First Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology Before Entering the U.S. Market, the Food Must Meet Other Federal Requirements
- October 6, 2020 - FDA Seeks Input on Labeling of Food Made with Cultured Seafood Cells
- March 7, 2019 - Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species
- Food Safety Modernization Act (FSMA)