On October 7, the U.S. Food and Drug Administration (FDA) published a request for comment on proposed labeling for cell-cultured seafood products. 85 FR 63277 (Oct. 7, 2020). Stakeholders now have an opportunity to comment on how these novel food products should be labeled, including appropriate descriptors for a product’s name, nature, source, and characteristics.

“Cell-cultured” refers to the process by which the seafood is created, in a sterile laboratory environment from the cells of a living or recently slaughtered animal. These cells are duplicated and harvested into products that mimic the taste, texture, and aesthetics of conventional seafood. The principal driver behind FDA’s request is to avoid misbranding of cell-cultured seafood products. The Federal Food, Drug and Cosmetic Act (FFDCA) prohibits the offering of food for sale under the name or label of another food, and FDA has acknowledged that consumers may not understand that “cultured seafood” is distinct from conventionally harvested seafood.  Simply put, FDA is legally required to ensure that food is accurately described on its label, and that non-standardized foods are labeled with terms that consumers can understand.

FDA suggested that there are no common usages of the term “cultured seafood” yet, and is inviting commenters to provide any evidence to the contrary. FDA has also asked for feedback on whether labeling should give details about the novel production method associated with these products. To that end, FDA requested input on the descriptor “cultured,” as consumers may be familiar with the term “aquaculture,” but not “cell-cultured production.” Commenters are also invited to explain why possible alternative terms may better describe the product (i.e., “cell cultured,” “cell-based,” or “cell-cultivated”).

FDA also asked whether labels should include a cell-cultured product’s type or cut – for example, fillet or steak – or other attributes like its taste, texture, aroma, or nutrition, if they differ from conventional seafood.

Comments may be submitted until March 8, 2021.

Beveridge & Diamond’s Pesticides and Biotechnology practices have worked for forty years with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use conventional pesticides and pesticides produced through biotechnology. We represent large and small companies with an emphasis on entities that invest in research to discover, develop, and defend new technology. Our Pesticides & Biotechnology practices help clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives. We will continue to track developments concerning the implementation of the federal labeling scheme for bioengineered foods and the rulemaking process more broadly. If you have any questions, please contact the authors.