The No. 1 Regulatory Issue for Cell-Cultured Food Developers

By Zoe Bilis, Associate Manager of Regulatory Policy, Biocom California
In the United States, the regulatory oversight of cell-cultured food products is shared by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS). Food made from cultured animal cells is regulated based on the animal species of the cells, and in 2019 these federal agencies signed a formal agreement outlining their roles in the regulation of human food produced using cell culture technology¹. Per the agreement, the FDA is responsible for regulating cell collection, cell banks, cell growth and differentiation, while the USDA-FSIS oversees the production and labeling of cell-cultured products².

FDA’s Office of Food Additive Safety (OFAS) within the Center for Food Safety and Applied Nutrition (CFSAN) is responsible for conducting a pre-market consultation process with developers to evaluate the safety of cell-cultured food by reviewing the production process including the establishment of manufacturing controls and cell lines. Once complete, regulatory oversight of the product is transferred to the USDA-FSIS where product developers must obtain a USDA inspection grant and meet food safety inspection regulations for cell-cultured meat and poultry.

In May 2023, Biocom California hosted its Energy & Agriculture Biotech Fly-In where California executives had the opportunity to travel to Washington, D.C., to advocate for issues impacting the industry and meet with high-level regulators and legislators; including teams from the USDA and FDA’s CFSAN. During these meetings, Biocom California and its members learned that many of the teams within CFSAN have a handful of employees who must review cell-cultured food products while also developing regulatory guidance for the cellular food industry. With few employees on these teams, there is a strain on federal staff and resources to review the continuously increasing number of cellular food applications while simultaneously producing guidance that aligns with the industry’s quickly evolving technology. Therefore, increased staffing and resources for these federal agencies are crucial to prevent the review of cellular food regulatory applications from bottlenecking.

Biocom California sent a letter to Congress this past June advocating for more robust funding for FDA’s CFSAN and USDA-FSIS in order to implement their joint regulatory framework for cell-cultured foods³. CFSAN requires increased staffing to keep pace with the advancements of the cell-cultured food industry and funding for additional employees with expertise in this field would streamline the regulatory review of applications and provide relief for both the agency and industry. Food biotechnology companies need a timely and reliable regulatory structure to continue their development of cell-cultured food products with clear regulatory expectations and a straightforward path to commercialization. Biocom California supports and continues to advocate for increasing resources to further innovate and adopt new cell-cultured food technologies, improve regulatory transparency and processes, and ensure a sustainable food supply for all.

¹Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species.
²Human Food Made with Cultured Animal Cells.
³Biocom California comments on the 2023 Farm Bill Reauthorization.