Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.
On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken. This is the first such consultation completed by the agency and, while not a formal approval process, means that FDA has no further questions about UPSIDE’s conclusions that (1) its production process is safe and (2) its cultured chicken cell products are as safe as comparable foods, like traditionally produced chicken leg meat.
Human food produced using animal cell culture technology is subject to an interagency regulatory framework between FDA’s Center for Food Safety & Applied Nutrition (CFSAN) and USDA’s Food Safety and Inspection Service (FSIS). Under the agencies’ formal agreement, both agencies agreed to a regulatory framework in which CFSAN regulates the initial steps of cell collection, cell banking, and cell differentiation. Once the cells are removed from their sealed growth environments at the harvest stage, FSIS oversees their further processing, labeling, and packaging.
To market its product, UPSIDE will still need to meet additional FDA requirements, such as food facility registration, and will need a grant of inspection from FSIS for the manufacturing establishment. The product itself also must bear a USDA mark of inspection. USDA has yet to issue any guidance or regulations addressing product labeling, so many questions remain regarding how cell-cultured foods can be marketed. If FSIS’s advance notice of proposed rulemaking is any indication, the agency’s eventual rulemaking on these issues will be hotly contested by industry and other interest groups.
UPSIDE submitted a Premarket Notice for Integral Tissue Culture Poultry Meat to FDA on October 1, 2021, and amended it multiple times in response to FDA’s requests for further information and points of clarification. FDA was particularly interested in the genetic engineering method UPSIDE uses to immortalize its cell lines, and its ability to maintain single-species lines free from microbial or chemical contamination. The consultation process spanned over a year and covered every step of the cell culture process, including (1) how the cells are isolated, (2) how the cell bank is maintained and monitored, (3) how the cells are multiplied and differentiated, and (4) how the cell material is harvested.
