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FDA Issues Draft Guidance on Labeling of Plant-Based Alternatives to Animal-Derived Foods

Young plant
Young plant

On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued draft guidance on the labeling of plant-based alternatives to animal-derived foods. The draft guidance provides best practices for naming plant-based alternatives to eggs, seafood, poultry, meat, and dairy products, excluding milk alternatives and animal proteins produced by microflora. FDA’s primary recommendation is that the statement of identity for plant-based alternatives should include a description of the specific plant source(s) (e.g., “chickpea and lentil-based fish sticks,” “chia and flax seed egg-less scramble”) and, taken together with other representations in the labeling, should not suggest to consumers that animal source(s) are present or have been used as ingredients. Comments on the draft guidance are due May 7, 2025.

Background

Plant-based alternative foods do not have established standards of identity and therefore are non-standardized foods. Non-standardized foods must be labeled with their common or usual names, or in the absence thereof, a statement of identity that accurately describes the food.1  When non-standardized foods lack an established common or usual name which, according to FDA, is often the case for plant-based alternatives, they must be labeled using an appropriately descriptive term that:

  • accurately identifies or describes the basic nature of the food or its characterizing properties or ingredients;
  • is uniform among identical or similar products and is not confusingly similar to the name of any other food not reasonably encompassed within the same name; and
  • uses a name that distinguishes from other dissimilar foods.

FDA recommends that manufacturers follow these principles, which come from FDA’s existing common or usual name regulation,in naming plant-based alternatives. The agency explains that doing so will help ensure that consumers understand the source of individual plant-based alternatives and have the information they need to make informed purchasing decisions.

Key Elements of the Draft Guidance

The key recommendations in the draft guidance include the following:

  • Statement of identity: FDA recommends that the statement of identity for plant-based alternatives should include a description of the specific plant source(s) and, taken together with other representations in the labeling, should not suggest to consumers that animal source(s) are present or have been used as ingredients.
    • FDA provides several examples of acceptable product names including “soy yogurt,” “almond yogurt,” “chickpea and lentil-based fish sticks,” “chia and flax seed eggless scramble,” “black bean mushroom veggie patties,” and “plant-based soy bacon.”
    • If the labeling of a plant-based alternative food includes the name of a standardized food as part of the statement of identity, FDA recommends that the name of the standardized food be qualified by the type of plant source. For example, FDA explains that “soy-based cheddar cheese” would be an acceptable name for a product that includes “cheddar cheese” (a standardized food) in the statement of identity.
  • Multiple plant sources: For plant-based alternative foods derived from several plant sources, FDA recommends including the primary plant sources, listing the predominant plant sources by weight first, in the statement of identity and declaring all plant sources by name in the ingredient statement. For example, FDA states that “Black Bean Mushroom Veggie Patties” would be an appropriate name for a product that contains a blend of black beans, mushrooms, and multiple vegetables, with black beans as the predominant ingredient.  In this example, the vegetables are still named in collective way in the statement of identity (“Veggie”).  FDA does not address instances where not all plant sources are characterizing ingredients.
  • Terms used in product names: While FDA recognizes that the use of truthful and non-misleading label statements such as “vegan,” “plant-based [animal derived food],” or “[animal or meat]-free” help inform consumers that the food is derived from plants rather than animals, FDA recommends not using only those terms as the product name or statement of identity, as those terms do not describe the nature of the plant source and therefore do not distinguish the product from other types of plant-based alternative foods. FDA explains that when looking at the name of the food on the label, consumers should be able to easily determine not just that the product is plant-based but also the plant source. For example, FDA states that names such as “plant-based burger” or “meatless meatballs” may signal to consumers that the food is a meat alternative but they do not identify the plant source comprising the food, whereas a name such as “plant-based chickpea & lentil-based fish sticks” does adequately identify the plant source.
  • Modified spellings: When using alternative spellings (e.g., “Chik’N,” “Cheeze”) in product names, FDA recommends that the name also describes the nature of the plant source, in order to distinguish the product from other types of plant-based alternative foods (an example might be “pea-based chik'n sausage” rather than “vegetarian chik’n sausage”).
  • Nutritional differences: Unlike in the draft guidance FDA issued in 2023 for plant-based milk alternatives such as soy milk and almond milk, this draft guidance does not include recommendations for making disclosures about nutritional differences between plant-based products and conventional animal products. For plant-based milk alternatives, FDA recommended that products that use “milk” in the name (e.g., “soy milk”), and that have nutrient compositions different from conventional milk, bear a voluntary nutrient statement on the product label describing how it is nutritionally different.3 Here, for plant-based alternatives other than milk alternatives, FDA explains that identifying the plant-based source in the name is sufficient to prompt consumers to understand that the composition of the product is different and that they should review the Nutrition Facts panel.
  • Characterizing flavors: FDA states that labels may use vignettes or other statements to convey a product’s characterizing flavors, provided that the statements do not communicate that the ingredients are animal-based when in fact they are plant-based. For example, FDA explains that a plant-based wheat jerky product that includes a cow vignette, should also include the phrase “artificially beef flavored” to convey the characterizing flavor but not imply that the product is derived from an animal source. The agency also reminds industry that characterizing flavors must be declared consistent with FDA labeling regulations.4
  • Prominence of statement of identity: FDA also includes a comment reminding industry about the prominence requirements for the statement of identity, which must be in bold type on the principal display panel in a size reasonably related to the most prominent printed matter.5  The agency reiterates its prior guidance that reasonably related means at least ½ the size of the largest print on the label.

Next Steps

Comments on the draft guidance are due May 7, 2025. We encourage trade associations and companies to submit comments to FDA and are available to assist with developing comment.

Interested stakeholders may want to comment on FDA’s tentative statement that many plant-based alternative foods are “novel” foods, and due to their novelty, common or usual names “do not appear to have been established by common usage.” Plant-based foods have been around for years and in some cases for decades, and we think there could be arguments that many of these products do in fact have common or usual names (e.g., “veggie burger”). Stakeholders may also want to comment on FDA’s rationale for recommending that the statement of identity include a description of the specific plant source(s). FDA states that omitting a descriptor of the plant source in the name of a food may be confusing to consumers, as the product would not be readily distinguishable from other types of plant-based alternatives. It would be particularly helpful to submit any data on how consumers understand current plant-based product names. 


Authored by: Veronica Colas and Rebecca Popkin

References

1  See 21 U.S.C. 343(i)(1) and 21 CFR 101.3(b).

2  See 21 CFR 102.5(a).

3 Our summary of FDA’s draft guidance on labeling of plant-based milk alternatives can be found here.

4  See 21 CFR 101.22(i).

5  See 21 CFR 101.3(d).


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