The U.S. Food and Drug Administration (FDA) recently completed its first pre-market consultation for a human food made with animal cell culture technology in response to a submission by UPSIDE Foods assessing the safety of a food produced from cultured chicken cells.1 In its response letter to the company’s submission, FDA stated that it did not identify a basis for concluding that the production process as described in the submission would be expected to result in food that bears or contains any substance or microorganism that would adulterate the food. This marks the first time FDA has completed a pre-market consultation for a human food derived from cultured animal cells.

Background

Cell culture technology for food production has advanced significantly in recent years, sparking the development of a regulatory framework with oversight shared between FDA and the U.S. Department of Agriculture (USDA). In March 2019, FDA and USDA’s Food Safety and Inspection Service (FSIS) reached an interagency agreement whereby both agencies agreed to jointly oversee the production of human food products derived from the cells of livestock and poultry.2 Under this joint regulatory framework, FDA conducts a pre-market consultation to evaluate production materials and processes and oversees cell collection, cell banks, and cell growth and differentiation.  During the cell harvest stage, oversight transitions to FSIS to oversee the production and labeling of human food products derived from these livestock and poultry cells.

FDA noted in its press release that the pre-market consultation process is a voluntary process by which firms can submit data to FDA for evaluation. Even after the firm (i.e., UPSIDE) completes this pre-market consultation process and FDA states that it has no further questions about the firm’s safety conclusion, the firm must still meet all applicable USDA and FDA requirements before its food products can be lawfully marketed.  The additional USDA requirements apply only to products involving cultivated animal cells subject to the Federal Meat Inspection Act (FMIA) or the Poultry Products Inspection Act (PPIA) for the purpose of producing human food.  For cultivated cells not subject to FMIA or PPIA (e.g., cultivated seafood cells), there are no additional USDA requirements. 

Next Steps

In its press release, FDA also stated that it is “committed to supporting innovation in the food supply” and is ready to work with additional firms in this space.3 Within the next few months, the agency plans to issue guidance to assist firms that intend to produce human foods from cultured animal cells to prepare for pre-market consultations. The agency intends to provide a formal opportunity for public comment on this guidance.

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We will continue to monitor all regulatory actions related to animal cell culture technology as it relates to food production. Please contact us if you have any questions.

Authored by Martin Hahn, Brian Eyink, Xin Tao, and Rachel Buff.

References

1 FDA Completes First Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology, U.S. Food and Drug Administration (Nov. 16, 2022), https://www.fda.gov/food/cfsan-constituent-updates/fda-completes-first-pre-market-consultation-human-food-made-using-animal-cell-culture-technology.

2 Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species, U.S. Food & Drug Administration (Mar. 7, 2019), https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell.

3 FDA Spurs Innovation for Human Food from Animal Cell Culture Technology, U.S. Food and Drug Administration (Nov. 16, 2022), https://www.fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology.