Human Food Made with Cultured Animal Cells
The ability to take a small number of cells from living animals and grow them in a controlled environment to create food is an emerging area of food science. Advancements in cell culture technology enable scientists to use animal cells obtained from livestock, poultry, or seafood to produce food products.
In 2019, FSIS and FDA established a formal agreement on how we would use our regulatory tools to help ensure that foods comprising or containing cultured animal cells entering the U.S. market are safe and properly labeled. This agreement laid out which parts of the process each agency would oversee and was the first step toward both developing the framework to support safe production of these foods and providing clarity to industry on the requirements for producing, distributing, and selling these foods in the U.S.
FSIS and FDA have held public meetings to better understand the science of animal cell culture technology, potential hazards, labeling considerations, and to listen to consumer concerns. FSIS and FDA will continue their open communication and engagement with stakeholders to foster innovation while ensuring the safety of our Nation’s food supply.
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 or fish, 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.
On March 7, 2019, FDA and 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, unadulterated, and truthfully labeled. Under this agreement, FDA will oversee the collection, growth, and the differentiation of living cells into various cell types, such as proteins and fats.. Regulatory jurisdiction transitions from FDA to FSIS during the harvesting stage of the cell-culturing process. FSIS will then also oversee the further processing, labeling, and packaging of these products.
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.
- FDA is responsible for regulating all live animals to be used as food up until they are presented for slaughter.
- 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), FSIS is responsible for regulation during slaughter, processing, packaging, and labeling.
- For foods not regulated under FMIA or PPIA (e.g., all seafood other than Siluriformes fish and game meat) or foods intended for animal consumption, FDA has sole jurisdiction.. FDA has issued applicable requirements under both the Federal Food, Drug, and Cosmetic Act (FFDCA) and Public Health Service Act.
Therefore, food products made from the cells of species regulated by FSIS under FMIA and PPIA will be regulated by FDA during cell collection, selection, and growth and by FSIS during subsequent harvest, processing, and labeling. Food products for human consumption made from cells of species not subject to FSIS jurisdiction (e.g., seafood other than Siluriformes and game meat) and food products for animal consumption will be regulated solely by FDA.
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. FDA will ensure that covered entities comply with applicable requirements, including facility registration and FDA’s Current Good Manufacturing Practices and preventive control requirements.
FDA’s pre-market consultation process evaluates the safety of foods made from cultured animal cells before they enter the market. As part of the pre-market consultation process, FDA evaluates the production process and produced biological material, including tissue collection, cell lines and cell banks, manufacturing controls, and all components and inputs. 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 AnimalCellCultureFoods@fda.hhs.gov. If firms intend to market the cultured animal cell food products, or any of the byproducts generated during the production process, for animal food, the firm should contact the Center of Veterinary Medicine, Division of Animal Feeds, at Animalfoodfirstname.lastname@example.org. FDA believes that both the agency and individual firms will benefit from ongoing discussions as the firms make technical and strategic decisions.
After a successful pre-market safety consultation, FDA will 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, 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. 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 FSIS principles for product labeling and claims.
Establishments that intend to harvest or process cell-cultured meat and poultry must apply for and obtain a USDA grant of inspection for such products using existing procedures. Such establishments must meet all applicable FSIS regulatory requirements, including the requirements for ensuring sanitation and developing and implementing Hazard Analysis and Critical Control Points systems. The design of the facility must also meet USDA regulatory requirements. Establishments that harvest cell-cultured meat and poultry should complete an FDA pre-market safety consultation before applying for a USDA grant of inspection.
During the cell harvesting stage, i.e., when an establishment begins the process of removing cells from the sealed growth environment to be prepared for traditional food processing, FDA and FSIS will work together to coordinate the transfer of regulatory oversight to FSIS. FSIS will carry out inspections at establishments where cells derived from livestock and poultry are harvested or processed. FSIS inspectors will review batch records produced during cell culturing and verify compliance with applicable FSIS regulatory requirements during product processing, packaging, and labeling to verify the cell-cultured meat and poultry products are safe, wholesome, unadulterated, and truthfully labeled. If cell-cultured meat or poultry is shipped to other establishments for further processing into human food products, these establishments also will be subject to FSIS inspection.
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 a USDA mark of inspection. Finally, FSIS will ensure that cell-cultured products are labeled truthfully and consistent with coordinated FDA and FSIS labeling principles. Under the requirements of FMIA and PPIA, all cell-cultured meat and poultry labeling must be preapproved by FSIS.
At this time, FSIS does not intend to establish new food safety inspection regulations governing cell-cultured meat or poultry, given its current regulations are immediately applicable to such products. However, as discussed in our advance notice of proposed rulemaking, FSIS does intend to publish new labeling regulations for such 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 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 FSIS’ system to ensure other non-food safety requirements (such as accurate labeling and assurance that meat and poultry products are not economically adulterated) are met. At this time, FSIS has not deemed any country eligible to import cell-cultured meat or poultry products into the United States for sale for human food.
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 USDA’s Animal and Plant Health Inspection Services (APHIS) and the U.S. Customs and Border Protection (CBP).
Imports of FSIS-Regulated Meat and Poultry Products For Non-Commercial Purposes
As with traditionally produced meat or poultry products, 9 CFR 327.19, 381.207, and 590.960 allow small amounts of cell-cultured products to be imported into the U.S. without meeting FSIS requirements for specific non-commercial purposes, such as for personal use, display, laboratory examination, research, and evaluative testing. Our procedures on the import of such products are located in FSIS Directive 9500.8, Importation of Products for Other than Commercial Purposes. Once imported, such products are subject to the same procedures as those produced domestically (see FSIS Directive 7000.2, Experimental and Sample Products Policy).
The import of cell-cultured meat and poultry for non-commercial purposes also will be subject to applicable requirements of APHIS and CBP.
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 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. FDA may detain shipments of products offered for import that appear to be in violation of FDA requirements.
More information about FDA’s requirements is available in these online resources:
- 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 and FSIS have held public meetings to better understand the science of animal cell culture technology, potential hazards, labeling considerations, and to listen to consumer concerns. FDA and FSIS will continue their open communication and engagement with stakeholders to foster innovation while ensuring the safety of our Nation’s food supply.
- USDA and FDA Launch Joint Webinar on Cultured Animal Cell Food and Feed 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)
- 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)
- 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 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)