FDA draft guidance intended to help people better understand plant-based alternatives to eggs, seafood, poultry, meat and some dairy products.
January 6, 2025
The Food & Drug Administration is releasing a draft guidance for industry Jan. 7 on best practices for naming and labeling plant-based alternatives to eggs, seafood, poultry, meat and dairy, excluding plant-based milk alternatives.
This guidance is intended to help consumers understand the nature of plant-based alternative foods, including differences among these products, so they can make informed decisions.
Consumer demand for plant-based alternatives to animal products has increased over time, with total U.S. retail plant-based food dollar sales growing from $5.5 billion in 2019 to $8.1 billion in 2023, according to the draft guidance document. Consumer research conducted by the Plant-Based Foods Association (PBFA) found that 70% of the total U.S. population consumes plant-based foods.
People purchase plant-based alternative foods for various reasons, such as dietary choices, allergies, taste preferences, religious practices and environmental concerns. According to PBFA, consumers typically use these foods in a similar way to animal-derived foods, such as for main dishes, side dishes or snacks.
The new draft guidance provides FDA’s recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for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 recommendations for manufacturers are intended to help ensure that 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.
FDA said the draft guidance may also help manufacturers of plant-based alternatives to animal-derived foods ensure that the labeling for, and names of, their products are truthful and not misleading and accurately describe the food. FDA’s assessment of whether the naming and labeling of these products complies with all relevant provisions of the Federal Food, Drug & Cosmetic Act (FD&C Act) will continue to be made on a case-by-case basis, considering the totality of the information.
Under the draft guidance, food products that do not have standards of identity must be labeled with their common or usual names. In the absence of a common or usual name, foods should be labeled with an accurate description of the food.
Manufacturers may include the name of animal-derived foods, such as “cheese” in the common or usual name or statement of identity of plant-based alternative foods, but the labeling should not suggest to consumers that animal sources are present or have been used as ingredients.
Since the composition of plant-based alternative foods varies, such foods may be considered part of different food groups (i.e., vegetable, protein or grain) depending on their composition.
Consumers should be able to know the specific plant source(s) in the food product, such as soybeans in “soy-based cheddar cheese” and black beans and mushrooms in “black bean mushroom veggie patties.”
Consumers should also be able to distinguish similar products from one another, such as, for example, distinguishing soy-based alternatives from those that are almond based. While the predominant plant source(s) should be part of the product name, all plant source(s) must be in the ingredient statement.
FDA said it intends this guidance to provide its view on best practices for clear and accurate plant-based alternative food labels to help enable consumers to quickly ascertain the attributes of products they are purchasing.
Interested parties may submit comments on the draft guidance for consideration through May 7, 2025, before FDA begins work on the final version of the guidance. Comments may be submitted electronically at www.regulations.gov or in writing.
Mail written comments to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.
All comments should be identified with docket number FDA-2022-D-1102 listed in the notice of availability published in the Federal Register.
FDA noted that the scope of this guidance includes only plant-based alternatives to eggs, seafood, poultry, meat and dairy products (excluding plant-based milk alternatives) that fall under FDA jurisdiction. This draft guidance does not address the naming and labeling of plant-based milk alternatives, which FDA is addressing separately in a draft guidance that was issued in February 2023.
FDA has regulatory authority over all plant-based alternatives to animal products under the FD&C Act, while the U.S. Department of Agriculture has regulatory authority over most animal products, e.g., meat products, poultry products, egg products and catfish.
FDA explained that its guidance documents generally do not establish legally enforceable responsibilities but instead describe its current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
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