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Alternative ProteinRegulatory Watch

FDA Issues Draft Guidance on Labeling Plant-Based Alternatives to Animal-Derived Foods

The FDA’s draft guidance includes plant-based alternatives to eggs, seafood, poultry, meat and dairy products (excluding plant-based milk alternatives) that fall under FDA jurisdiction.

Plate of food
Photo courtesy of Getty Images Plus / AscentXmedia
March 4, 2025

The U.S. Food and Drug Administration has issued draft guidance with recommendations on best practices for naming and labeling plant-based foods that are marketed and sold as alternatives for animal-derived foods, especially in the absence of a common or usual name for the product.

The agency says these recommendations for manufacturers are intended to help consumers understand the nature or source of individual plant-based alternative foods, including differences among these products, and have the information they need to make informed purchasing decisions.

The FDA also notes the draft guidance may help manufacturers of plant-based alternatives to ensure the naming and labeling of their products are “truthful and non-misleading and accurately describe the food.” The FDA’s assessment of whether the naming and labeling of these products complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) will continue to be made on a case-by-case basis, considering the totality of the information.

The scope of this guidance includes plant-based alternatives to eggs, seafood, poultry, meat and dairy products (excluding plant-based milk alternatives) that fall under FDA jurisdiction.

Specifically, the FDA notes:

“Plant-based alternative foods tend to be sold in packaged form, and therefore, in the absence of a common or usual name, should be labeled with a statement of identity that accurately describes the food. The statement of identity should not mislead consumers as to the source of the food. Its description should inform consumers of the specific plant source(s) and, along with other representations in the labeling, should not suggest to consumers that animal source(s) are present or have been used as ingredients.”

In general, the FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance means that something is suggested or recommended, but not required.

The FDA is accepting comments on this draft guidance through May 7.

KEYWORDS: FDA plant-based plant-based foods plant-based meats

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