Federal Regulatory Framework for Cell-Cultured Meat and State Legislative Action

Updated: Nov 5, 2020

By Sarah Everhart

Photo of cows on a farm. Image by Edwin Remsberg.

Photo of cows on a farm. Image by Edwin Remsberg.

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Last fall, I posted about about discussions of the U.S. Food and Drug Administration (FDA) and Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) pertaining to the regulation and labeling of cell cultured meats sometimes referred to as “clean meats”.

To briefly recap the agencies’ roles and positions, FDA (pursuant to Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 301, et seq.)), the Public Health Service Act ((42 U.S.C. 201, et seq.)), and the Fair Packaging and Labeling Act ((15 U.S.C. 1451 et seq.))) is responsible for ensuring that food (produce, dietary supplements, processed food, seafood, etc.) and drugs are safe and labelled properly. To carry out this mission for food, FDA conducts inspections of establishments that manufacture, process, pack, or hold foods, with the exception of certain establishments that are regulated exclusively by USDA. In the cell-cultured meat context, FDA felt it was prepared to regulate cell-cultured meats because of its experience in regulating new food technologies and additives.

By contrast, USDA-FSIS (pursuant to the Federal Meat Inspection Act (( 21 U.S.C. 601, et seq.)), the Poultry Products Inspection Act ((21 U.S.C. 451, et seq.)), and the Egg Products Inspection Act ((21 U.S.C. 1031, et seq.))) ensures meat, poultry and egg products are safe by having inspectors present in meat and poultry slaughter and processing establishments and egg products processing plants. As for cell-cultured meat, USDA-FSIS felt it was well suited to regulate cell-cultured meat due to its current role in ensuring a safe meat supply.

On March 7, 2019, the FDA and the USDA-FSIS announced a formal agreement to jointly oversee the production of cell-cultured meats. According to the agencies, they “…recognize that each Party has an important role in the oversight of human food, derived from cell lines of USDA-amenable species and required to bear a USDA mark of inspection.”

Under the newly announced joint regulatory framework, FDA and USDA-FSIS will oversee different aspects of cell-cultured meat during its processing and production. A broad overview of the agreed upon