GUIDANCE DOCUMENT
Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods January 2025
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-1102
- Docket Number:
- FDA-2022-D-1102
- Issued by:
-
Guidance Issuing OfficeHuman Foods Program
This draft guidance provides FDA’s recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for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 (plant-based alternative foods), especially in the absence of a common or usual name for the product. These 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.
This draft guidance may also help manufacturers of plant-based alternatives to animal-derived foods ensure that the labeling for, and names of, their products are truthful and non-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, 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. This draft guidance does not address the naming and labeling of plant-based milk alternatives; that topic is being addressed elsewhere.
In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our 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.