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Last month the U.S. Food and Drug Administration (FDA) and Department of Agriculture (USDA) met again to discuss the regulation and labeling of cell cultured meats sometimes referred to as “clean meats”. According to a recent Congressional Research Service Report, “a number of U.S. cell-cultured meat companies are developing products that some believe could be sold within three years in certain markets and widely available in 10 years.”
What is cell-cultured meat?
According to the FDA, “animal cell culture technology” is defined as “the controlled growth of animal cells from livestock, poultry, fish, or other animals, the subsequent differentiation into various cell types, and the collection and processing into food.” How cell-cultured meat is defined can impact its regulation and form the basis of claims that the labeling of cell-cultured meat is misleading. For example, some foods have a definition or standard of identity in the law. FDA is charged with making sure foods meet the the minimum quality specifications, including permitted ingredients and processing requirements as defined in law.
States are also starting to take action on the labeling of cell-cultured meat. For example, a law recently passed in Missouri (Mo. Rev. Stat. § 265.494(7), 265.496) making it a misdemeanor to sell a product represented as “meat that is not derived from harvested production livestock or poultry.”
Who should be in charge of regulating and labeling cell cultured meat?
FDA and the USDA Food Safety and Inspection Service (FSIS) ensure that our food supply is unadulterated, wholesome, and properly labeled and both agencies have claimed oversight of cell-cultured meats in some capacity. FDA argues it is best prepared to regulate cell-cultured meats because of its experience in regulating new food technologies and additives. Aside from produce, FDA regulates manufactured food items such as baby formula, dietary supplements, and livestock feeds and pet foods. It also regulate vaccines, allergenics, and cellular and gene therapy products. Extending the scope of FDA regulations to cell-cultured meats may not be huge leap from these products. Additionally, the laboratories in which cell-cultured meats are produced are similar to the food manufacturing facilities that FDA already regulates. However, the product being produced in these laboratories is engineered from the cells of animals and animal products are regulated by the USDA-FSIS.
Currently, the statutory definition of a ‘meat product’ in the Federal Meat Inspection Act (FMIA) includes, “any product . . . made wholly or in part from any meat or other portion of the carcass.” (21 U.S.C. 601(j)). Under this definition, cell-cultured meat would argubly fall under USDA-FSIS’s jurisdiction. If cell-cultured meats are considered meats, they would fall into the same category as beef, pork, and chicken in terms of regulation, and therefore under the scope of the USDA-FSIS.
Why do we care who regulates cell-cultured meat?
Whether the FDA or the USDA regulates cell-cultured meats is important because the decision could change what producers are required to do when manufacturing the product. If the USDA regulates cell-cultured meat, the product would be subject to the FMIA which requires inspections of livestock and poultry before and after slaughter, sanitary standards for slaughterhouses, mandatory labeling requirements, and ongoing inspections of both slaughterhouses and meat packaging facilities. By contrast, FDA, is authorized by the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure good manufacturing practices, inspections of facilities and standards for branding and marketing. Under this law, all food additives are regulated to ensure health and safety as well as inspections of the facility in which the engineering occurs. Additionally, the FDA created a Biotechnology Policy specifically implemented to address regulations around foods created solely in engineering laboratories. While the original creation of the Biotechnology Policy was aimed at genetically modified plants, the purpose of the policy could be applied to protect consumers of engineered meats as well.
National Cattlemen's Beef Assn. (NCBA) president-elect Jennifer Houston, in a statement prepared for the joint USDA/FDA meeting, said, “Ensuring lab-grown fake meat products are subject to strong, daily inspection by USDA's trained professionals is essential. The health of consumers is on the line, and USDA is far better suited to ensure the safety of lab-grown products.”
As current technologies improve, products such as cell-cultured meats will continue to challenge regulatory definitions and classifications. Keep reading this blog for future updates on how technology impacts food production and regulation.