On 16 November 2022, the U.S. Food and Drug Administration (FDA) announced that it had completed its first pre-market consultation for “human food made from cultured cells,” also known as “cell-based” foods. “Human food made from cultured animal cells” refers to growing animal cells in a controlled environment to produce food without sacrificing animals.
UPSIDE Foods Inc. (UPSIDE), based in Berkeley, California, submitted its “Premarket Notice for Integral Tissue Cultured Poultry Meat” to FDA on 1 October 2021. In the submission, UPSIDE detailed a self-assessment of its cell-based chicken product’s safety from the standpoint of genetic modifications to the cell line, process controls, nutrient media, characterization of the finished product, potential contaminants, and other issues. In its response to UPSIDE, FDA addressed each of these safety issues in turn and approached its review in a manner consistent with the Hazard Analysis and Risk-Based Preventive Controls regulatory framework, which is a mandatory set of food safety regulations applicable to the vast majority of food companies supplying food to the U.S. market.
It is relevant to note that FDA’s response to UPSIDE, while favorable, is technically not an “approval.” FDA’s response to UPSIDE is akin to its responses to voluntary Generally Recognized As Safe Notifications, in which a favorable response is known as a “no questions letter.” Technically, FDA’s action indicates that it agrees with the safety assessment conducted by UPSIDE and that food produced as described in UPSIDE’s submission will be safe for human consumption.
What is next for UPSIDE to get its cell-based chicken onto the market? There is shared jurisdiction between FDA and the U.S. Department of Agriculture (USDA) with regard to most cell-based technologies like UPSIDE’s. Under the agreement between the two agencies, FDA conducts a premarket safety review with respect to all manufacturing up until the harvesting phase. After the cells have been harvested from the bioreactor, USDA’s Food Safety and Inspection Service will regulate the safe handling of the products, as well as review finished product labeling. This USDA role is akin to its current jurisdiction over traditional meat and poultry products, where the agency ensures the safe and hygienic handling of such foods at meat processing plants. There is no word yet on UPSIDE’s consultation with USDA.
FDA has encouraged other companies developing cultured animal cell foods to be proactive in communicating with the agency well ahead of making any submissions. Based on the UPSIDE submission having been assigned the number Cell Culture Consultation 000002, it is clearly not the first to have communicated with the agency, and we expect FDA to make additional consultations public in the future as they are completed.
If you have questions regarding the FDA pre-market consultation process or need further information on FDA regulatory matters, K&L Gates, LLP is happy to assist.
 FDA Completes First Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology, FDA, 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.
 Human Food Made with Cultured Animal Cells, FDA, https://www.fda.gov/food/food-ingredients-packaging/human-food-made-cultured-animal-cells
 Premarket Notice for Integral Tissue Cultured Poultry Meat, UPSIDE FOODS, Oct. 1, 2021, https://www.fda.gov/media/163262/download?utm_medium=email&utm_source=govdelivery.
 FDA and USDA, Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-Amenable Species, (March 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. Consistent with the current division of USDA/FDA jurisdiction, FDA will have exclusive jurisdiction over seafood and non-Siluriformes fish.