From time to time on the blog, I’ve commented on the emerging field of foods derived from cultured animal cells, and how these products would be regulated by governments around the world. In today’s post, I’m catching up with some recent developments in the United States, relating to how the U.S. Food and Drug Administration (FDA) is carrying out its roles in oversight over such products.
As I reported back in 2018 in the blog, the FDA and the U.S. Department of Agriculture (USDA) issued a statement on November 16, 2018 to announce that the agencies would work together to develop a regulatory framework for cell-based meats. The statement said:
“Drawing on the expertise of both USDA and FDA, the Agencies are today announcing agreement on a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry.”
This was followed by a more formal agreement announced in March 2019, setting out agencies’ responsibilities in more detail. Among other responsibilities, it stated that FDA would maintain oversight over the initial processes of cell collection and growth, and in particular that the agency would “conduct premarket consultation processes to evaluate production materials/processes and manufacturing controls, to include oversight of tissue collection, cell lines and banks, and all components and inputs”.
I’m not aware of any subsequent formal announcement from FDA regarding a “premarket consultation process”, but in November 2022 the agency announced that it had reviewed the first product under such a program. In this announcement, the agency referenced the March 2019 USDA agreement, and said “The FDA’s approach to regulating products derived from cultured animal cells involves a thorough pre-market consultation process. While this is not considered an approval process, it concludes when all questions relevant to the consultation are resolved”.
FDA’s voluntary consultation program for human food made from cultured animal cells is described on its website. Although there does not appear to be a more definitive description of how a company would go about requesting voluntary consultation, the web page describes the process as follows:
The FDA’s voluntary pre-market consultation process evaluates the safety of food made from cultured animal cells before it enters the market. The pre-market consultation allows developers to work with the FDA on a product-by-product basis and informs them of issues they must consider to produce safe food that does not violate the Federal Food, Drug and Cosmetic Act’s requirements. As part of the pre-market consultation process, we evaluate the production process and the cultured cell material made by the production process, including the establishment of cell lines and cell banks, manufacturing controls, and all components and inputs. Our goal is to support innovation in food technologies while always maintaining as our priority the production of safe food.
We encourage firms to have conversations with us often and early in their product and process development phase. We are already engaged in discussions with multiple firms about various types of food made from cultured animal cells, including seafood and food destined for animal diets.
As of this date, two products have received “no questions” letters from the FDA under the voluntary consultation program: food products made from cultured chicken cells from UPSIDE Foods (November 2022) and GOOD Meat, Inc. (March 2023). In both cases, the agency posted on its website the nonconfidential version of the company’s original submission and any amendments, the agency’s “no questions” letter sent to the submitter, and a detailed internal FDA memo summarizing the basis for their finding.
According to FDA’s summary memos, the UPSIDE Foods product consisted of cultured Gallus gallus [chicken] cells, with characteristics of myocytes and fibroblasts, in the form of sheets of cells. The GOOD Meat product also consisted of cultured Gallus gallus cells, in this case derived from a commercially-available chicken cell line UMNSAH/DF1, with characteristics of fibroblasts. Unlike the sheets of cells used in the UPSIDE process, the GOOD Meat process uses a cell paste arising from the harvested cells. In both cases, FDA “evaluated information about the cell lines, the production process (including cell bank establishment), substances used in the production process, and properties of the harvested cell material, including information available in both the disclosable safety assessment as well as supporting, corroborative information in a confidential supplementary appendix”. For each product, FDA concluded that “based on the data and information presented in [the submission], we have no questions at this time about [the company’s] conclusion that foods comprised of, or containing, cultured chicken cell material resulting from the production process defined in [the company’s submission] are as safe as comparable foods produced by other methods”.
FDA’s Inventory page lists only these two submissions that have successfully completed FDA review. The site does not list, or indicate, whether there have been other submissions that are currently undergoing review, but it is reasonable to assume that there have been other submissions. One page on the FDA website says “We are already engaged in discussions with multiple firms about various types of food made from cultured animal cells, including seafood and food destined for animal diets”.
Although there does not appear to be any specific guidance for companies regarding how to prepare a dossier for consideration under this program, the agency’s website says that for questions about the pre-market consultation process for human food, companies should contact the agency’s Center for Food Safety and Applied Nutrition, Office of Food Additive Safety at AnimalCellCultureFoods@fda.hhs.gov. For cultured animal cell food products, or any of the byproducts generated during the production of process, intended for use in animal food, firms should contact the Center for Veterinary Medicine, Division of Animal Food Ingredients, at Animalfood-premarket@fda.hhs.gov.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty-five years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. In addition to his work as a consultant assisting industrial biotechnology companies prepare for and comply with government regulations, he has served as Director of Regulatory Affairs for Joule Unlimited Technologies and Vice President of Government and Regulatory Affairs for BioTechnica International. Dr. Glass has extensive experience with the biotechnology regulations of the U.S. EPA and other agencies, and has coordinated or assisted in the preparation and submission of 18 successful Microbial Commercial Activity Notices and several other biotechnology submissions in the U.S. and other countries. Dr. Glass holds a B.S. in Biological Sciences from Cornell University and a Ph.D. in Biochemical Sciences from Princeton University.
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