There is a long history of scientific advances in biology, biochemistry, and engineering that have led to the innovations enabling the growth of animal cells outside of the animal itself, in a controlled environment, for food. The process, while complex, can be broadly summarized in a few steps.

• Step 1: Scientists typically start with a sample of cells from the tissue of an animal, a process that typically does not permanently harm or kill the animal. Some cells from the sample are selected, screened, and grown to make a “bank” of cells to store for later use.
• Step 2: To make food, a small number of cells are taken from the cell bank and placed in a tightly controlled and monitored environment (e.g. a very large sealed vessel) that supports growth and cellular multiplication by supplying appropriate nutrients and other factors.
• Step 3: After the cells have multiplied many times over into billions or trillions of cells, additional factors (e.g., protein growth factors, new surfaces for cell attachment, additional nutrients) are added to the controlled environment to enable the cells to differentiate into various cell types and assume characteristics of muscle, fat, or connective tissue cells.
• Step 4: Once the cells have differentiated into the desired type, the cellular material can be harvested from the controlled environment and prepared using conventional food processing and packaging methods.

There are currently no food products made from cultured animal cells in the U.S. market. Manufacturers are generally working on scaling up their processes to consistently produce amounts large enough to be competitively priced.

In 2019, the FDA and USDA-FSIS agreed to establish a joint regulatory framework for human foods made from cultured cells of livestock and poultry to help ensure that any such products brought to market are safe and truthfully labeled.  Under this agreement, the FDA oversees cell collection, cell banks, and cell growth and differentiation. The FDA transitions oversight to USDA oversight during the harvesting stage of the cell-culturing process. USDA-FSIS will then oversee the further production and labeling of these products. As part of the formal agreement, the FDA and USDA-FSIS are working to develop detailed procedures to facilitate coordination of shared regulatory oversight related to the harvest of the cultured animal cells.

Regulatory oversight of human foods comprised of or containing cultured animal cells depends on the animal species used as the original source of cultured cells, and it is based on the agencies’ existing jurisdiction over products.

• The FDA is responsible for regulating all live animals to be used as food up until processing. 
• For those animals intended for human consumption and regulated under the Federal Meat Inspection Act (FMIA) (i.e., cattle, sheep, swine, goats, and fish of the order Siluriformes) or the Poultry Products Inspection Act (PPIA)(i.e. chicken, turkeys, duck, geese, guineas, ratites, and squab), USDA-FSIS is then responsible for regulation during processing. 
• For foods made from the cultured cells of animals not regulated under the FMIA or PPIA or foods intended for animal consumption, the FDA is responsible for regulation during processing.  The FDA has issued applicable requirements under both the Federal Food, Drug, and Cosmetic Act (FFDCA) and Public Health Service Act.

Therefore, food products for human consumption made from cells of species not subject to USDA jurisdiction (e.g., seafood other than Siluriformes and game meat), and food products for animal consumption will be regulated solely by the FDA. Food products made from the cells of species regulated by the USDA under the FMIA and PPIA will be regulated by the FDA during cell collection, selection, and growth and by the USDA-FSIS during subsequent processing and labeling.

To view the FDA-USDA FSIS Agreement, please visit Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species.

Overview of the Pre-Market Consultation Process and Oversight Activities

FDA Regulatory Oversight

As described in the March 2019 formal agreement, FDA’s approach to regulating products derived from cultured animal cells will involve a thorough pre-market consultation process and inspections of records and facilities. The FDA will ensure that covered entities comply with applicable requirements, including facility registration and FDA’s Current Good Manufacturing Practices and preventive control requirements.
 
The pre-market consultation process includes evaluating the production process and produced biological material, including tissue collection, cell lines and cell banks, manufacturing controls, and all components and inputs. The FDA encourages firms working on the culture of animal cells for food use to contact the agency early in the development phase to begin discussions. For human food, firms may contact the Center for Food Safety and Applied Nutrition, Office of Food Additive Safety at [email protected]. If firms intend to market the cultured meat, or any of the byproducts generated during the production of cultured meat, for animal food, firms should contact the Center of Veterinary Medicine, Division of Animal Feeds, at [email protected]. The FDA believes that both the agency and individual firms will benefit from ongoing discussions as the firms make technical and strategic decisions and as the agency begins to implement the consultation process.

After a successful pre-market safety consultation, the FDA intends to conduct routine inspections on an ongoing basis, as well as other oversight activities at cell banks and facilities where cells are cultured, differentiated, and harvested. These inspections will help to ensure that potential risks are being managed and that biological material exiting the culture process is safe and not adulterated within the meaning of the FFDCA.

In conducting inspections and other oversight activities, the FDA will be able to draw on the results of the pre-market consultation and a thorough assessment of production records maintained by the facility. Should FDA inspections uncover areas of noncompliance, the agency will take appropriate action. The FDA also will ensure that labeling of cell cultured products derived from animal species not subject to USDA jurisdiction is truthful and not misleading, consistent with coordinated FDA and USDA-FSIS principles for product labeling and claims.

USDA Regulatory Oversight

During the cell harvesting stage, when cells are removed from a sealed growth environment and prepared for traditional food processing, the FDA and USDA-FSIS will work together to coordinate the transfer of regulatory oversight to USDA-FSIS. USDA-FSIS will carry out inspections at establishments where cells derived from livestock and poultry are harvested. These establishments will be required to have USDA grants of inspection and meet the USDA-FSIS regulatory requirements, including the requirements for ensuring sanitation and developing and implementing Hazard Analysis and Critical Control Points systems.

USDA-FSIS inspectors will review batch records produced during cell culturing and verify compliance with applicable USDA-FSIS regulatory requirements during product processing, packaging, and labeling to verify the cellular products are safe, wholesome, unadulterated, and truthfully labeled. If cells are shipped to other establishments for further processing into human food products, these establishments also will be subject to USDA-FSIS inspection.

USDA-FSIS inspection of cell harvest and processing will occur at a frequency of at least once per shift, the inspection frequency also required for processing traditional meat and poultry products. This level of verification is necessary for products to receive the USDA mark of inspection. Finally, the USDA-FSIS will ensure that cell-based products are labeled truthfully and consistent with coordinated FDA and USDA-FSIS principles for product labeling and claims. Under the requirements of the FMIA and PPIA, all labeling of human food products made from the cultured cells of livestock or poultry must by preapproved by FSIS.

Imports of USDA-Regulated Meat and Poultry Products

Like imports of traditionally produced meat and poultry products, imports of meat and poultry products made from the cultured cells of livestock and poultry must originate from eligible countries and from establishments or plants that are certified to export to the United States. A country becomes eligible to export to the United States following an equivalence process, through which FSIS determines whether its inspection system achieves the same level of public health protection as is applied by FSIS in the United States.  Additionally, the foreign food safety inspection system must provide standards equivalent to the FSIS to ensure other non-food safety requirements (such as accurate labeling, and assurance that meat and poultry products are not economically adulterated) are met.

Imports of meat and poultry products made from the cultured cells of livestock and poultry will also be subject to all of the other FSIS requirements for imports, including labeling requirements and reinspection by FSIS at an official import establishment.  These imports also will be subject to applicable requirements of the USDA Animal and Plant Health Inspection Services (APHIS) and U.S. Customs and Border Protection.

Imports of FDA-Regulated Products

Like all FDA-regulated foods, imports of foods comprising or containing cultured fish or seafood cells must meet the same legal requirements as domestically produced foods, including requirements related to the absence of unapproved food additives, color additives, or other substances that may adulterate the food.

Imported foods comprising or containing cultured fish or seafood cells must also meet specific agency requirements and are subject to oversight through multiple programs, including:

• registration of any foreign facilities that engage in manufacturing, processing, packaging, or holding of the food,
• prior notice to the FDA that the food is being imported or offered for import, and
• implementation of a foreign supplier verification program by the importer to ensure that their foreign supplier is producing food in a manner that provides the same level of public health protection as FDA’s preventive controls regulations and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

Imported food products are subject to FDA inspection when offered for import at U.S. ports of entry. The FDA may detain shipments of products offered for import that appear to be in violation of FDA requirements.

More information about FDA’s requirements for imported food can be found here:

• Importing Food Products into the United States
• Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507: Guidance for Industry
• What do importers need to know about the Foreign Supplier Verification Programs (FSVP) rule? FDA Strategy for the Safety of Imported Foods

FDA Announcements

• FDA Seeks Input on Labeling of Food Made with Cultured Seafood Cells (October 6, 2020)
• USDA/FDA Launches Joint Webinar on Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products (July 31, 2020)
• USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry (March 07, 2019)
• Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry (November 16, 2018)
• USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry (September 10, 2018)

FDA and USDA-FSIS Public Meetings

• USDA and FDA Joint Public Meeting on the Use of Cell Culture Technology to Develop Products Derived from Livestock and Poultry (October 23-24, 2018)
• October 22, 2018: Science Board to the FDA Meeting Announcement (October 22, 2018)
• FDA Public Meeting on Foods Produced Using Animal Cell Culture Technology (July 12, 2018)

Resources

• Overview of FDA and USDA Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products Webinar (July 31, 2020)