On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued its Draft Guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods. The draft guidance outlines FDA’s recommendations for naming plant-based egg, seafood, poultry, meat, and dairy products (other than milk[1]) in compliance with FDA’s naming requirements for non-standardized foods. The draft guidance expressly “excludes animal proteins produced by microflora,” such as those produced using precision fermentation. Interested stakeholders should provide comments on the draft guidance by May 7, 2025, after which point FDA will begin work on the final guidance.
I. FDA’s Naming Requirements for Non-Standardized Foods
The Federal Food, Drug, and Cosmetic Act (FDCA) and FDA’s implementing regulations require that the labels of non-standardized foods (i.e., foods for which FDA has not issued a standard of identity) bear the common or usual name of the food or, if there is no such name, an accurate description of the food or a fanciful name commonly used by the public.[2] The draft guidance notes that while many plant-based alternatives are foods for which no common or usual name has been established, manufacturers should look to FDA’s general principles for identifying common or usual names when selecting names for these foods.[3] For example, appropriate names should describe the basic nature of the food, should be uniform among identical or similar products, and should adequately distinguish between classes or subclasses of a product. Against this backdrop, the draft guidance provides specific recommendations for naming plant-based alternatives.
II. FDA’s Recommendations
The draft guidance’s primary recommendation—and one that could pose implications for many currently-marketed plant-based products—is that the statement of identity for plant-based alternatives should identify the specific plant source(s) from which the food is derived (e.g., “soy chicken,” “black bean mushroom veggie patties,” “chickpea and lentil-based fish sticks”). The draft guidance notes that, while general terms like “plant-based” can help convey that a product is not animal-derived, such terms do not, by themselves, adequately distinguish a food from other plant-based alternatives and therefore do not provide consumers with sufficient information to make purchasing decisions. Thus, while terms like “plant-based” can be used as part of a product’s name, the draft guidance recommends that such terms be accompanied by language that identifies the specific plant source(s) in the product (e.g., using “plant-based soy-bacon” instead of just “plant-based bacon”).
Other key recommendations in the draft guidance include:
- If a product contains multiple plant sources, the draft guidance recommends including the “primary” plant sources in the product name, starting with the predominant plant source by weight. So, for example, if a product contains black beans (as the predominant ingredient), mushrooms, and multiple other vegetables, an appropriate name might be “black bean mushroom veggie patties.” Any plant sources not identified in the product name would still need to be identified in the product’s ingredient statement.
- The draft guidance states that plant-based foods are not precluded from using the names of animal-derived foods, including standardized foods (e.g., “chicken,” “bacon,” “jerky”), as long as such terms are adequately qualified (i.e., by identifying the type of plant source). The same principle applies when using modified versions of animal-derived food names (e.g., “Chick’N, “Be’f”).
- While terms such as “[animal or meat]-free” can be used in the labeling of plant-based foods, the draft guidance recommends that the specific plant source(s) be included in the food’s name alongside those terms (e.g., “pork-free soy-bacon”). The same principle applies when using terms like “vegan.”
- While labels can use vignettes or other statements to convey a plant-based product’s characterizing flavor, the draft guidance states that they must do so in a manner that complies with FDA’s flavor labeling regulations[4] and in a manner that does not imply that the product contains animal-based ingredients. For example, if the label of a plant-based beef jerky product contains a cow vignette to convey the characterizing flavor, the product should contain an “artificially beef flavored” declaration, since none of the product’s flavor is derived from it’s characterizing flavor ingredient (i.e., beef). The statement of identity should also identity the product’s plant source(s).
The draft guidance also reiterates that statements of identity on plant-based product labels must adhere to the same formatting and prominence requirements applicable to other FDA-regulated food labels.[5] This means, for example, that these statements must be in bold type on the principal display panel in a type size that is reasonably related to the most prominent printed matter on that panel.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
[1] FDA issued separate draft guidance on the labeling of plant-based milk alternatives in February 2023, as summarized in this Covington client alert.
[2] FDCA § 403 (21 U.S.C. § 343); 21 C.F.R. § 101.3.
[3] These principles are codified at 21 C.F.R. § 102.5.
[4] FDA’s flavor labeling regulations are codified at 21 C.F.R. § 101.22(i).
[5] These requirements are codified at 21 C.F.R. § 101.3(d).
Back
