In 2019, FDA and the United States Department of Agriculture (“USDA”) issued a memorandum of understanding announcing a formal agreement to jointly oversee the production of human food products derived from animal cells. Under this framework, each agency will regulate the labeling of products falling under its jurisdiction, but FDA and USDA have committed to developing joint principles for product labeling and claims. This RFI is specific to FDA-regulated seafood products but could also inform the agencies’ joint principles. For purposes of the RFI, FDA uses the term “cell cultured” in the document but notes that the term does not indicate the agency is expressing a perspective on that term. This analysis follows that convention.
The RFI is informed by and includes a brief summary of FDA’s existing regulatory authorities to ensure seafood is properly named for product labeling, which may provide insight into the legal considerations driving the agency’s thinking. It is worthwhile to review the specific statutory provisions cited by FDA as providing insight as to what authorities are viewed as relevant to possible future regulation, particularly with respect to how foods are named (i.e., statement of identity).
Request for Information
The RFI includes 5 specific questions, with subparts, for a total of 16 prompts. FDA is seeking information related to the name of foods, such as whether the statement of identity should inform consumers about how the animal cells were produced, as well as descriptions about the nature, source, or characteristics of the food. Other questions consider whether the term “cultured” may require additional differentiation from existing products such as “aquaculture;” whether certain cuts should be included in product names (e.g., “steak” or “fillet”); and how FDA’s existing Seafood List relates to cell-cultured product naming or descriptions. Collectively, the questions offer a roadmap for the types of issues that FDA is considering in naming these novel products.
Throughout the questions, FDA repeatedly requests scientific data and studies, often focused on consumer understanding, a point reinforced in FDA’s press release announcing the RFI.
FDA’s specific questions follow:
- Should the name or statement of identity of foods comprised of or containing cultured seafood cells inform consumers about how the animal cells were produced? Please explain your reasoning.
- 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? (For example, possible terms could be "cell cultured" or "cell based" or "cell cultivated.") Please explain your reasoning and provide any studies or data about consumer understanding of such terms.
- How do these terms inform consumers of the nature or source of the food?
- If foods comprised of or containing cultured seafood cells were to be labeled with the term "culture" or "cultured" in their names or statements of identity (e.g., "cell culture[d]"), would labeling differentiation be necessary to distinguish these products from other types of foods where the term "culture" or "cultured" is used (such as "aquaculture")? Please explain your reasoning and provide any studies or data about consumer understanding of such terms.
- The names of many conventionally produced seafood products have been established by common usage or by statute or regulation. Names are also recommended for seafood species in The Seafood List. In FDA's view, 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.
- If you disagree with FDA's view, what are these names and what evidence demonstrates that the names are commonly used and understood by the American public for foods derived from cultured animal cells?
- Should names for conventionally produced seafood products established by common usage, statute, or regulation be included in the names or statements of identity of food derived from cultured seafood cells? Please explain your reasoning.
- If so, is additional qualifying language necessary? What qualifying terms or phrases would be appropriate? Please explain your reasoning.
- Do these names, with or without qualifying language, clearly distinguish foods derived from seafood cell culture from conventionally produced seafood? Please explain your reasoning.
- Should FDA update The Seafood List to include foods comprised of or containing cultured seafood cells? Please explain your reasoning.
- Should terms that specify a certain type of seafood (such as "fillet" or "steak") be included in or accompany the name or statement of identity of foods comprised of or containing cultured animal cells?
- Under what circumstances should these terms be used? What information would they convey to consumers? For example, would such terms convey the physical form or appearance of the food? Please explain your reasoning. Additionally, please provide any studies or data about consumer understanding of such terms when used to describe foods comprised of or containing cultured seafood cells.
- Would these terms be misleading to consumers? Please explain your reasoning and provide any supporting studies or data.
- When comparing conventionally produced seafood to foods comprised of or containing cultured seafood cells, what attributes (such as nutrition, taste, texture, or aroma) vary between the foods and should FDA consider to be material to consumers' purchasing and consumption decisions? Please explain your reasoning.
- Are there other characteristics beyond nutritional attributes or organoleptic properties that may be material differences? These could relate either to cellular constituents or characteristics influenced by the cell culture production process. Please be specific in your response and explain your reasoning.
Please let us know if you have questions.
84 Fed. Reg. 63277 (Oct. 7, 2020), https://www.govinfo.gov/content/pkg/FR-2020-10-07/pdf/2020-22140.pdf.
Authored by Steve Steinborn, Brian Eyink and Mary Lancaster