FDA Issues Draft Guidance on Labeling of Plant-Based Milk Alternatives

Yesterday, FDA issued a draft guidance setting forth its recommendations for the naming and labeling of plant-based milk alternatives, including a specific recommendation for the use of voluntary nutrient label statements to identify differences in nutrient content between a plant-based milk product and milk from cows.

The draft guidance comes after many years of FDA, stakeholder, and Congressional interest in and engagement on this issue, including a 2018 FDA Request for Comments on the Use of the Names of Dairy Foods in the Labeling of Plant-Based Products, in response to which FDA received more than 13,000 comments. The draft guidance only applies to the labeling of plant-based milk, and not to other plant-based dairy products.

FDA’s Findings

The draft guidance includes a substantive discussion of consumer understanding of plant-based milk alternatives that could be instructive not just for this category, but more broadly for understanding how FDA will approach the issue of naming of plant-based alternatives more generally. Notably, FDA explains that it reviewed multiple consumer studies and conducted a number of focus groups, which, overall, indicate that consumers understand that plant-based milk alternatives do not contain milk from cows and that “milk” is strongly rooted in consumers’ vocabulary when describing and talking about plant-based milk alternatives.

On naming specifically, FDA describes the general framework for the naming of products that are not subject to a standard of identity, and specifically clarifies that “[t]he fact that a standard of identity has been established for a food (under its common or usual name) or that a name is specified among the standard of identity regulations for a food does not preclude use of the name in the common or usual name of another food.”

FDA explains further that plant-based milk alternatives are not “milk” as set forth in FDA’s standard of identity for milk, because they are made from plant materials rather than the

lacteal secretion of cows, and therefore cannot be offered for sale as “milk.” Notably, FDA concludes that, although many plant-based milk alternatives are labeled with names that include the word “milk” (e.g., “soy milk”), these products do not purport to be nor are they represented as milk, and consumers do not understand them to be “milk.” FDA states further that the names of some plant-based milk alternatives appear to be established by common usage, such as “soy milk” and “almond milk.”

FDA also notes that the research the agency reviewed indicates that consumers do not necessarily understand the nutritional differences between milk and plant-based milk alternatives, which supports FDA’s recommendations on certain voluntary nutrient label statements, discussed more below.

FDA’s Recommendations

Based on the above, the draft guidance includes the following recommendations for the labeling of plant-based milk alternatives:

Naming

• In the names of plant-based milk alternatives, the term “milk” (or “beverage” or “drink”) should be qualified by the plant source of the food. The name may be a single word (i.e., “soymilk”), multiple words (e.g., “soy milk”), or hyphenated (e.g., “soy-milk”).
• FDA does not think that “plant based” is a sufficiently descriptive qualifier, and instead recommends identifying the specific plant source(s). FDA reasons that consumers should be able to easily determine the particular plant source when looking at the product name. FDA also does not think that terms such as “dairy free” or “non dairy” are sufficiently descriptive qualifiers without more specific information about the plant source(s).
• If a plant-based milk alternative is derived from different plant sources, the different plant sources should be included in the name, and the predominant plant source should be stated first in the name or statement of identity. For example, a plant-based milk alternative that is a blend of walnuts and cashews, with walnuts predominating, should be labeled with “walnut” first, followed by “cashew”; possible names include: “Walnut & Cashew Milk,” “Walnutmilk with Cashewmilk,” or “Walnut-Cashew Milk.”
• Plant-based milk alternatives are generally not “imitation” products as that term is defined under section 403(c) of the FDCA. To the extent a particular product would qualify as an “imitation” product, FDA intends to exercise enforcement discretion regarding use of that term.

Voluntary Nutrient Statements

• FDA recommends that plant-based milk alternatives that use the term “milk” in their name (e.g., “soy milk,” “almond milk,” “oat milk,” etc.) and have a nutrient composition that is different than milk (based on USDA’s FNS fluid milk substitutes nutrient criteria) bear an additional nutrient statement on the product label describing how it is nutritionally different. The USDA FNS fluid milk substitutes nutrient criteria includes nine nutrients: calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, and vitamin B12.
• FDA makes this recommendation because consumer research indicates that consumers may not understand the nutritional differences between plant-based milk alternatives and milk. The draft guidance makes clear that such a statement would be voluntary.
• FDA recommends that the voluntary nutrient statement use the following format: “Contains lower amounts of [nutrient name(s)] than milk.” It should appear on the principal display panel of a product, “near and visually connected to the name of the product if space allows,” or, if not, connected to the PDP through the use of an asterisk or other symbol.
• If the label of a plant-based milk alternative includes a relative claim comparing the product’s nutrition profile to milk (e.g., “50% more calcium than milk”), FDA recommends that the voluntary nutrient statement appear next to the relative claim and be as prominent on the food label as the relative claim so that it is easily identifiable for consumers.
• If a plant-based milk alternative is named with a term other than “milk,” (e.g., “beverage,” “drink”) and bears a relative claim comparing the product to milk (e.g., “50% more calcium than milk”), FDA also recommends including a voluntary nutrient statement about other found in milk that are present in lower amounts in the plant-based milk alternative.

FDA is accepting comments on the draft guidance until April 24, 2023. FDA has specifically requested comment on the following questions:

1. The recommended placement of and possible space constraints for the voluntary nutrient statement on product labels, understanding that space on certain products may be limited.
2. Whether the USDA criteria that identifies minimum levels of nutrients for fluid milk substitutes are the most appropriate criteria to use for the voluntary nutrient statements. If yes, why? If not, what criteria (i.e., nutrients and nutrient levels, minimums versus ranges of nutrient levels, etc.) should FDA consider and why?

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.