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FDA Solicits Information and Comments on Labeling of Food Made with Cultured Seafood Cells

As covered on this blog, on March 7, 2019 the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) published a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” whereby FDA will have regulatory oversight at the stages of collection, growth and differentiation of cells and USDA oversight will begin at cell harvest for food products derived from the cultured cells of livestock and poultry.  For food derived from cultured seafood cells, other than cells from Siluformes fish under USDA jurisdiction, FDA oversight will continue over the processing, packaging, and labeling stages.  In this regard, the 2019 agreement provides that FDA and USDA will develop joint principles for product labeling and claims to ensure that products under each agency’s jurisdiction are labeled consistently and transparently.

In an October 7, 2020 Federal Register notice, FDA solicited comments, studies, and relevant data or information on consumer understanding of terms pertaining to the labeling of foods comprised of or containing cultured seafood cells.  The 5 topics for which input is solicited are:

1. Whether the name or statement of identity of foods comprised of or containing cultured seafood cells should inform consumers about how the animal cells were produced;

2. What terms should be in the name or statement of identity of a food comprised of or containing cultured seafood cells to convey the nature or source of the food to consumers, e.g., “cell cultured” or “cell based” or “cell cultivated;”

3. Whether there is agreement with FDA’s view that foods comprised of or containing cultured seafood cells are not yet in the marketplace and, therefore, do not have common or usual names established by common usage;

4. Whether terms that specify a certain type of seafood (such as “fillet” or “steak”) should be included in or accompany the name or statement of identity of foods comprised of or containing cultured animal cells; and

5. What attributes (such as nutrition, taste, texture, or aroma) vary between conventionally produced seafood as compared to foods comprised of or containing cultured seafood cells, and should be considered material to consumers’ purchasing and consumption decisions.

FDA has provided additional questions in subparts for certain of the above topics and has requested an explanation of the reasoning for each comment that is submitted, along with studies, data, and other supporting evidence as applicable to the topic that is being addressed.  The solicitation period for comments is scheduled to close on March 8, 2021. 

© 2021 Keller and Heckman LLPNational Law Review, Volume X, Number 286
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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