FDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling Plant-Based Alternatives

Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here, here, and here).

Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods.  This latest draft guidance outlines the Agency’s recommendations for naming and labeling plant-based foods that are marketed and sold as alternatives for animal-derived foods that fall within FDA’s jurisdiction—namely, plant-based alternatives to eggs, seafood, poultry, meat, and dairy products (except milk).

Most notably, FDA recognizes that plant-based alternatives may use the name(s) of animal-derived foods, provided that using such terms would not cause the labeling to be false and misleading, particularly as to the source(s) of the food.  In addition, FDA recommends that specific plant source(s) be included in the statement of identity of plant-based alternative food products, regardless of whether the name of the product is accompanied by “plant-based,” “vegan,” “meat-free,” or similar, or whether the name has modified spelling (e.g., “Chik’N”).

The draft guidance lays out the law, regulation, and FDA’s thoughts on naming foods. Under the Federal Food, Drug, and Cosmetic Act (FDC Act) and FDA’s implementing regulations, FDA has established definitions and standards of identity for certain foods.  Products that purport to be or are represented as a food for which FDA has established a definition and standard of identity must conform to that definition and standard, and their labels must bear the name specified in the definition and standard.  For foods that do not have established definitions and standards of identity (i.e., “non-standardized foods”), their labeling must bear the common or usual name of the food, if such a name exists.  In the absence of a common or usual name or other name established by federal law or regulation, food sold in packaged form must be labeled with an appropriately descriptive term or a fanciful name commonly used by the public.  The description or name of the food (i.e., the statement of identity) must not be false or misleading.

In the draft guidance, FDA acknowledges that many plant-based alternative foods do not have common or usual names.  Therefore, they must be labeled with a statement of identity that accurately describes the food.  In determining whether a plant-based alternative food product’s name accurately describes the food, FDA considers (a) whether the name accurately identifies or describes the basic nature of the food or its characterizing properties or ingredients, (b) whether the name uniform among identical or similar products, and (c) whether the name is confusingly similar to the name of any other food that is not reasonably encompassed within the same name.  Using these criteria, FDA explains that the names of classes or subclasses of foods should distinguish one class or subclass from another (e.g., plant-based alternatives to yogurt that are soy-based should bear names that distinguish these products from those that are almond-based).

The existence of a standard of identity for an animal-derived food does not foreclose the use of that term in a plant-based alternative.  As described in the guidance, the name can be modified to clarify how the product differs from the food subject to the standard. Perhaps most obvious, the labeling may not suggest that animal source(s) are present or have been used as ingredients.  FDA specifically recommends that, if the labeling of a plant-based alternative food includes the name of a standardized food as part of the statement of identity, the name of the standardized food be qualified by the type of plant source, e.g., “Chickpea-Based Fish Sticks” or “Dairy-Free Soy-Based Cheddar Cheese” instead of “Plant-Based Fish Sticks” or “Plant-Based Cheddar Cheese”.  In addition, consumers should be able to readily observe the particular plant source of a plant-based alternative food when reading the product label.

For a plant-based alternative food derived from several plant sources, FDA recommends a statement of identity that includes the primary plant sources so consumers can more easily identify them and distinguish the food product from similar foods that may be derived from other plant sources.  Specifically, in case of more than one plant source, FDA recommends that the predominant plant source by weight be stated first.

FDA’s guidance seems generally consistent with its regulation on naming foods.  It also appears consistent with the draft guidance on the labeling of plant-based milk alternatives, where FDA also recommended that the names of plant-based milk alternatives be qualified with the plant source from which it is derived.  It seems a “win” to the extent that FDA is confirming the use of traditional animal nomenclature for the naming of plant-based alternatives.  However, given the similarities between these draft guidance documents, similar comments may be expected.

Comments on the draft guidance may be submitted until May 7, 2025.