By: Vanessa Fulton and Daniel Dwyer
On Wednesday, February 22, 2023, FDA issued a draft guidance regarding labeling of plant-based milk alternatives. The draft guidance addresses the question of whether a plant-based milk alternative (PBMA) can use the word “milk” in the product name and recommends that, if applicable, the label of a PBMA include a statement that the PBMA is lower in certain nutrients than dairy milk.
Appropriate Name for Plant-Based Milk Alternatives
The draft guidance clarifies that PBMAs can indeed use “milk” as part of the product name, despite the fact that FDA has established a standard of identity for “milk.” This is consistent with a longstanding FDA approach to the use of standardized names. In 1983, for example, FDA stated:
“…in some cases, it may be reasonable and appropriate to include the name of a standardize[d] food or other traditional food in the name of a substitute food in order to provide the consumer with an accurate description. When this is done, the name of the food must be modified such that the nature of the substitute food is clearly described and is clearly distinguished from the food which it resembles and for which it is intended to substitute. The modification of the traditional or standardized food’s name must be descriptive of all differences that are not apparent to the consumer.
The draft guidance also states that the appropriate name for a PBMA must specify the plant source. If a PBMA is derived from several sources or is a blend of different plant sources, the name should identify each source, with the predominant plant source stated first.
Recommendations for Additional Statements on Labeling
In addition to clarifying that PBMAs may use the word “milk” in the name, the draft guidance also provides several recommendations regarding the labeling of PBMAs.
- While PBMAs do not need to be labeled “dairy free” or “non-dairy,” FDA “encourages” the use of these terms to help inform consumers. However, the term “dairy-free milk” is not an adequate name for any PBMA because it does not specify the nature of the plant source.
- FDA recommends that PBMAs that use the term “milk” in their name and that are lower in certain nutrients specified in USDA’s FNS fluid milk substitutes nutrient criteria (calcium, protein, vitamin A, vitamin D, magnesium, phosphorus, potassium, riboflavin, or vitamin B12) bear an additional nutrient statement describing how it is nutritionally different. The guidance makes clear that this statement is voluntary.
- This voluntary nutrient statement should appear on the principal display panel (PDP) and be near and visually connected to the name of the product. The voluntary nutrient statement should also be prominent so that it is easily identifiable for consumers. The label may use a symbol next to the name of the product that directs consumers to the voluntary nutrient statement on the PDP. If the name of the product appears in multiple places on the label, FDA recommends that the voluntary nutrient statement (or a symbol leading consumers to the voluntary nutrient statement) be placed next to the product name each time it appears on the PDP, but this is not necessary when the product name appears elsewhere on the label.
- PBMAs may make relative claims comparing the product’s nutrition profile to milk on the PDP. However, if the PBMA contains lower amounts of nutrients specified in USDA’s FNS fluid milk substitutes nutrient criteria (calcium, protein, vitamin A, vitamin D, magnesium, phosphorus, potassium, riboflavin, or vitamin B12), then FDA recommends that the voluntary nutrient statement identifying the lower levels of the specified nutrients be placed on the PDP next to the relative claim, either in proximity or through the use of a symbol. The voluntary nutrient statement should also appear just as prominently as the relative claim so that consumers can easily identify both.
The guidance also clarifies that PBMAs do not need to be labeled as “imitation milk.” Specifically, FDA states that it intends to exercise enforcement discretion with respect to the “imitation” labeling requirement for PBMAs, explaining that the purpose of the “imitation” labeling requirement in section 403(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(c)) was to protect the consumer from uninformed purchase of an inferior substitute product which could be mistaken for a traditional food product. FDA explains that, in the context of PBMAs, consumers generally do not mistake plant-based milk alternatives as milk and understand they are distinct products.
FDA’s draft guidance is consistent with case law that has developed over the past several years finding that states cannot restrict the use of “milk” as part of a product name simply because FDA has established a standard of identity for “milk.” Like these cases, the guidance makes clear that consumers understand that PBMAs do not contain milk, and in some cases purchase PBMAs because they are not milk. Other cases have applied similar reasoning to holdings that plant-based butter and meat substitutes may not be prohibited from being labeled with the terms “butter” or “meat” in a truthful and non-misleading way.
KKB attorneys would be pleased to answer any questions about the draft guidance or discuss how it might impact the labeling of a plant-based alternative product.
 48 Fed. Reg. 37,666, 37,667 (Aug. 19, 1983). See also 44 Fed. Reg. 3964, 3965 (Jan. 19, 1979) (“[T]he existence of a standard of identity for a particular food does not necessarily preclude the use of the standardized name in connection with the name of a non-standardized food, and ‘in some cases it may be necessary to include a standardized name in the name of a substitute food in order to provide the consumer with accurate, descriptive, and fully informative labeling’.”) and 38 Fed. Reg. 20,702, 20,703 (Aug. 2, 1973) (“One trade association suggested that the regulation should preclude the use of a standardized name in connection with the name of a nonstandardized product. The Commissioner rejects this suggestion because in some cases it may be necessary to include a standardized name in the name of a substitute food in order to provide the consumer with accurate, descriptive, and fully informative labeling.”).
 Appendix 1 to the guidance document includes a table that identifies the nutrient criteria.
 See e.g., Ang. v. Whitewave Foods Co. et al., Case No.: 13-cv-1953, 2013 WL 6492353 (N.D. Cal. Dec. 10, 2013) (“… [I]t is simply implausible that a reasonable consumer would mistake a product like soymilk or almond milk with dairy milk from a cow. The first words in the products’ names should be obvious enough to even the least discerning of consumers.”); Gitson v. Trader Joe’s, Case No. 13-cv-01333, 2015 WL 9121232 (N.D. Cal. Dec. 1, 2015) (“The plaintiffs cannot state a claim because they have not articulated a plausible explanation for how ‘soymilk’ is misleading. . . . [P]laintiffs seem to suggest the term is misleading because people might mistake soymilk for actual milk from a cow, but that is not plausible. The reasonable consumer (indeed, even the least sophisticated consumer) does not think soymilk comes from a cow. To the contrary, people drink soymilk in lieu of cow’s milk.”).
 See, e.g., Turtle Island Foods SPC v. Soman, 424 F.Supp.3d 552, 574 (E.D. Ark. 2019) (“It is true, as the State contends, that these labels use some words traditionally associated with animal-based meat. However, the simple use of a word frequently used in relation to animal-based meats does not make use of that word in a different context inherently misleading.”); Miyoko’s Kitchen v. Ross, No. 20-CV-00893-RS, 2021 WL 4497867 (N.D. Cal. Aug. 10, 2021) (finding that Miyoko’s use of “butter” for its “vegan butter” product was not inherently misleading and did not generate meaningful consumer confusion).