Cultured Animal Cells—What Are They?
Before we assess the regulation and labeling of cell-cultured meat, let’s take a brief look at how it is created. Developing cell-cultured meat requires first collecting animal cells from livestock, poultry, and seafood for screening and growing in a “cell bank.” See U.S. Food & Drug Admin., Food Made with Cultured Animal Cells (current as of Oct. 6, 2020). Typically, the collection process does not permanently harm or kill the animal. Id. Next, a select number of the cells are placed in a controlled environment, which “supports growth and cellular multiplication by supplying appropriate nutrients and other factors.” Id. After the cells multiply, they are combined with nutrients, protein growth factors, and salts, which allow the cells to assume characteristics of muscle, fat, or collective tissue cells. Id. Thereafter, the cellular material can be harvested and prepared using conventional food processing and packaging procedures. Id.
Companies around the world are using this groundbreaking technology to develop products they hope to put on the market soon. In fact, just this past December, Singapore became the first nation to approve a cell-cultured product for sale: cultured chicken. While Singapore remains the only country to introduce cell-cultured proteins into the market, several companies in the United States are hoping to follow suit.
So when can consumers in the United States expect to purchase their first lab-grown animal product? The answer depends, in large part, on the establishment of a regulatory framework that will govern the marketing and labeling of cell-cultured products.
Regulation of Cell-Cultured Meat Products
Cell-cultured meat products have not been approved for sale in the United States, but that may change in the near future, as lawmakers are currently evaluating how the product should be regulated and labeled. In November 2018, the FDA and the USDA announced that, together, they would oversee the production of cell-cultured proteins. In March 2019, the two agencies entered a formal agreement specifying their roles as they relate to which agency will oversee which parts of the production and distribution of cultured-cell food products. Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species (Mar. 7, 2019). Their specific roles are covered under the Federal Meat Inspection Act (21 U.S.C. § 601 et seq.) and the Poultry Products Inspection Act (21 U.S.C. § 451 et seq.), but in short, the FDA “will oversee the collection, growth and differentiation of livestock and poultry cells until cell harvest,” the agency stated in its October 7, 2020, request for information. U.S. Food & Drug Admin., Labeling of Foods Comprised of or Containing Cultured Seafood Cells; Request for Information, 85 Fed. Reg. 63,277 (Oct. 7, 2020). During the cell harvesting stage, a “handoff” will occur between the FDA and the USDA’s Food Safety and Inspection Service (FSIS), which will entail the FDA providing FSIS information necessary for it to “determine whether harvested cells are eligible to be processed into meat or poultry products that will bear the USDA mark of inspection” under the formal agreement between the FDA and USDA. The USDA will then “oversee the processing, packaging, and labeling of the resulting food products derived from the cultured cells of livestock and poultry,” according to the FDA’s October 7, 2020, request for information. The FDA will also conduct premarket consultations and inspections of records and facilities and will ensure the entities comply with applicable requirements.
In the years since forming the interagency agreement, the FDA and USDA have held public meetings and sought public comment on potential regulations regarding animal cell culture technology. In July 2018, the FDA held a public meeting, “Foods Produced Using Animal Cell Culture Technology,” which invited public comments regarding cell-cultured food products. A few months later, in October 2018, both the FDA and USDA held another meeting, “Joint Public Meeting on the Use of Cell Culture Technology to Develop Products Derived From Livestock and Poultry,” at which the agencies sought comment from stakeholders regarding, among other topics, labeling issues.
In its October 7, 2020, request for information, the FDA invited comments regarding how cell-cultured seafood should be identified, how to assess differences between cell-cultured protein products, and consumer understanding of terms that have been suggested for naming foods comprising cultured seafood cells. The FDA expressed concern that foods containing cultured seafood cells may be misbranded and sought the public’s input to ensure the names and descriptions in food labeling are based on consumer understanding and usage, as is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 343 et seq.). The FDA received comments from stakeholders and individual entities alike. Several commenters urged the FDA to adopt and memorialize the sole use of the term “cell-cultured” to support uniform labeling within the seafood category, while others suggested using phrases like “grown from cells” or “engineered using cultured cells.” The comment period ended on March 8, 2021, but the FDA has not yet announced what action it will take next.
Apart from the foregoing initial steps, the FDA and USDA have not taken many additional steps to establish the regulatory framework under which cell-cultured proteins will be governed. Perhaps frustrated by this inaction, the Alliance for Meat, Poultry, and Seafood Innovation and the North American Meat Institute submitted a letter dated October 19, 2020, to the USDA urging it to issue an Advance Notice of Proposed Rulemaking “to obtain more information and supporting data on finished product characteristics for cell-based/cultured meat and poultry products, particularly those that may require labeling.” The groups commended the FDA and USDA for taking the initial steps to establish a regulatory framework, but they emphasized the need for the United States to maintain its leadership role in the science-based food industry by further developing principles and standards for cell-cultured proteins.
Looking Ahead
While neither the FDA nor the USDA has announced when we might expect a regulatory framework to be formalized, manufacturers interested in producing cell-cultured meat products can help shape it. First, they can attend and participate in meetings like those hosted by the FDA and USDA in July and October of 2018. In its October 7, 2020, request for information, the FDA said that “[p]articipation in public meetings is an important opportunity to share our current thinking on the science surrounding new technologies, how our regulatory framework may apply to new technology, and most importantly, to hear from the public.” Second, manufacturers can submit public comments when solicited by the FDA or USDA, or both, to help shape how cell-cultured meats may be labeled and regulated. Finally, manufacturers hoping to urge the FDA and USDA to move more quickly on establishing a regulatory framework might consider writing to one or both of the agencies and urge them to take action, as the Alliance for Meat, Poultry, and Seafood Innovation and the North American Meat Institute have done.
