Does the Food and Drug Administration (FDA) have the regulatory tools and experience necessary to regulate cell-cultured “meat”?
In a public meeting on July 12, 2018, FDA discussed how meat produced using cell-culture technology fits under its current regulatory framework for food safety.1,2 Does this mean that FDA does not view cell-cultured “meat” to be a “meat food product,”3 which would traditionally be regulated under the jurisdiction of the United States Department of Agriculture (USDA)? If the food ingredients produced from cell-cultured technologies were regulated under FDA’s jurisdiction, the food ingredients would be required to meet the food safety standard of “reasonable certainty of no harm” under the intended conditions of use of the ingredient or product. Regulations established under the Food Safety Modernization Act (FSMA) would also be enforced by FDA to ensure risk-based approaches are applied to control potential hazards associated with the manufacturing, processing, packing and holding of cell-cultured meat. The FDA argued that its prior experience with holding other cell-cultured ingredients to the existing food safety standards supports that the agency has the expertise necessary to evaluate the safe use of cell-cultured meat. The regulatory framework for bringing cell-cultured “meat” to market would be slightly different, however, if it were regulated as a “meat food product.”
Regulation of Cell-Cultured Meat Under FDA’s Jurisdiction
If regulated by FDA, under the Federal Food, Drug and Cosmetic Act (FFDCA), cell-cultured meat will have to meet the definition of “food” as defined under Section 201(f) and be safe and not adulterated (Section 402). The FDA also explained that the safety of the ingredients in cell-cultured “meat”, and the “meat” as a whole, must pose a “reasonable certainty of no harm.” The safety of a food ingredient can lawfully be established under its intended conditions of use via FDA’s pre-market approval of a Food Additive Petition (FAP) or Generally Recognized as Safe (GRAS) conclusion by a panel of experts (with the voluntary option to notify FDA of the GRAS conclusion). Within an FAP or GRAS dossier, the intended use levels, chemical characterization and specifications, and manufacturing processes must be evaluated in order to establish the safe intended use of the ingredient, which in this case would likely be the finished cell culture-derived “meat” product.
For cell-cultured “meat,” the method of manufacture poses the potential for significant hazards that must be assessed, such as keeping cell lines free of bacterial contaminants, ensuring the safety of the cell growth media and avoiding other contaminants during the production process. However, FDA argued that adherence to 21 CFR 117,4 which was a regulation implemented under FSMA, would adequately address hazards associated with the manufacturing of cell-cultured “meat.” Per 21 CFR 117, cell-cultured “meat” would not only have to be manufactured according to current Good Manufacturing Practice (cGMP), but also the production facilities would be required to have one or more Preventive Controls Qualified Individuals (PCQIs) prepare or oversee the preparation of a Food Safety Plan (FSP).5 Within the FSP, hazards (i.e., biological, chemical — including radiological — or physical) present in the manufacturing process (as well as the processing, packing and holding of food products) are assessed and risk-based preventive controls6 are established to prevent, eliminate or reduce the identified hazards.
To support that the existing regulatory framework and FDA’s expertise are suitable to ensure the safe use of cell-cultured meat, the agency provided examples of legal food ingredients that are either cultured cells, produced by cultured cells or produced by biotechnology. There are currently enzymes (e.g., produced by yeast or fungi), oils (e.g., produced by algae) and transgenic proteins (e.g., genes removed from organisms and inserted into bacteria to produce proteins) on the market that are all produced by cultured cells. Select bacterial, algal and fungal cells have also been approved as food additives or concluded to be GRAS. The agency argued the successful application of the existing food safety regulations to the lawfully marketed cell-cultured food ingredients not only supports the fact that these regulations are applicable, but additionally that FDA has the necessary experience to safely regulate cell-cultured “meat.”
Although not discussed in the public meeting, under the FFDCA, FDA also has experience with regulating some animal products (e.g., rabbit, moose, elk or deer) not included under the Federal Meat Inspection Act (FMIA) of 1906 and birds (e.g., pheasants or quail) that are not covered by the Poultry Products Inspection Act (PPIA) of 1957. The experience FDA has from regulating such products will likely be applicable to aspects of FDA’s proposed regulatory framework for cell-cultured “meat.”
Additionally, under the FFDCA, FDA has regulatory jurisdiction over fruits and vegetables derived from genetically modified plants. If a genetically modified organism (GMO) is produced that has a significantly different structure, function or composition or intended use than substances legally marketed in or as foods, then the safety and regulatory compliance of the substance must be evaluated. When determining the safety of GMO products, the potential for “significantly increased levels of plant toxicants or anti-nutrients, reduction of important nutrients, new allergens or the presence in the food of an unapproved food additive” must be considered.7 Many of these considerations will be applicable in the evaluation of cell-cultured “meat” as well. For example, if cell-cultured “meat” is going to replace or reduce the consumption of “meat food products” harvested from traditionally grown animals, will cell-cultured “meat” deliver comparable nutrients (e.g., digestible amino acids or fats)? Or, would cell-cultured “meat” reduce the consumption of important nutrients and not satisfy consumers’ nutritional requirements?
Regulation of Cell-Cultured Meat Under USDA’s Jurisdiction
If cell-cultured “meat” were to be considered a “meat food product,” it would be regulated under the USDA’s jurisdiction [i.e., Food Safety and Inspection Service (FSIS)] and the regulatory framework would be slightly different. Although FDA would likely remain responsible for assessing the safety of the ingredients, it would be FSIS’s responsibility to determine whether the ingredient is suitable for use in “meat food products.”8,9 FSIS requires that GRAS substances be listed in the Code of Federal Regulations (CFR) or be notified to FDA and obtain a letter of “no objection” (which must be provided to FSIS) to be considered for use in “meat food products.” For this reason, a self-affirmed (but not notified) GRAS conclusion would not be acceptable. Alternatively, an ingredient could be approved through a FAP. Regardless if an ingredient is approved via a FAP or has been concluded to be GRAS (with a “no objection” letter from FDA), FSIS must deem the ingredient safe and suitable for the intended technical purpose(s), based on data supplied by the ingredient manufacturer.
In conclusion, depending on whether FDA and/or FSIS has jurisdiction over cell-cultured “meat,” the pathway(s) to obtain regulatory compliance differ. As additional information becomes available on which agency will have regulatory jurisdiction over cell-cultured “meat,” Burdock Group will keep clients informed and looks forward to assisting clients with their regulatory compliance needs.
U.S. FDA. Regulatory Framework for Food Safety at FDA. Public Meeting on Foods Produced Using Animal Cell Culture Technology, July 12, 2018. Site last visited Aug. 1, 2018.
U.S. FDA. FDA’s Historical Experience with Food Safety Evaluation and Future Considerations. Public Meeting on Foods Produced Using Animal Cell Culture Technology, July 12, 2018. Site last visited Aug. 1, 2018.
As defined in the Federal Meat Inspection Act of 1906, “The term “meat food product” means any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and which are exempted from definition as a meat food product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat food products. This term as applied to food products of equines shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats.” Site last visited Aug. 2, 2018.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Site last visited Aug. 2, 2018.
For additional information on Food Safety Plans, please consider reading the following article, FSMA Key Requirements: Food Safety Plans and Preventive Controls Qualified Individuals. Site last visited Aug. 1, 2018.
For additional information on risk-based preventive controls, please consider reading the following article, Food Safety Plans: Risk-Based Preventive Controls. Site last visited Aug. 1, 2018.
Consultation Procedures Under FDA’s 1992 Statement of Policy – Foods Derived From New Plant Varieties. Revised 1997. Site last visited Aug. 3, 2018.
Food Ingredients and Sources of Radiation Listed and Approved for Use in the Production of Meat and Poultry Products. Final Rule, 2013. Site last visited Aug. 2, 2018.