On February 22, 2023, the U.S. Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.[1] Significantly, under the draft guidance, FDA will not prohibit the use of the identifier “milk” in plant-based milk alternatives but does recommend the product be labeled with “voluntary nutrient statements” to help consumers understand the nutritional differences in the products.

Over the past decade, plant-based milk alternatives have dramatically increased in both availability and consumption. During this time, industry stakeholders have disagreed over the use of the term “milk” for plant-based alternatives that do not contain milk from cows. The dairy industry has lobbied both federal and state governments to restrict the use of “milk” to only fluid “obtained by the complete milking of one or more healthy cows.”[2] To address this debate and to acknowledge the exponential increase in the sale of plant-based milk products, FDA issued a notice for public comment in September 2018 on the “Use of Name of Dairy Foods in the Labeling of Plant-Based Products” that amassed over 13,000 comments. The recently issued draft guidance indicates that the agency did in fact rely on the findings from this notice in developing its recommendations.

The draft guidance begins by discussing consumers’ understanding of plant-based milk alternatives. Based on findings from FDA-conducted focus groups and industry research, FDA concluded that consumers are not confused about plant-based milk alternatives containing milk from cows and that using the term “milk” in plant-based milk alternatives is “strongly rooted in consumers’ vocabulary.” However, FDA found that consumers do not appear to understand the nutritional differences between plant-based milk and cow-derived milk. This conclusion helped inform the agency in drafting its recommendations, which places an emphasis on disclosing these nutritional differences on product labeling.

Draft Guidance Recommendations

Naming of Plant-Based Milk Alternatives

• Standard of Identity

Under the Federal Food, Drug and Cosmetic Act (“FDCA”), “non-standardized foods” must be labeled using the common or usual name, which can be established through regulation or common usage. The draft guidance states that although there is no established standard of identity for plant-based milk products, some common and usual names have been established by common usage for such products such as “soy milk” and “almond milk”. FDA states that names that include the terms “beverage” or “drink” are also common usage although used less frequently.

Additionally, in the names of plant-based milk products, the term “milk”, “beverage”, or “drink” should be qualified by the plant source of the food. Simply including “plant-based” or “plant” would not satisfy the identification of the plant source and should only be used in conjunction with plant source qualifiers.

• Imitation Foods

FDCA section 401(c) defines “imitation foods” as food that “substitutes for and resembles another food and is nutritionally inferior to the product.” While FDA acknowledged that plant-based milk alternatives generally do not meet this definition, to the extent a product would qualify as an “imitation” product, FDA intends to exercise enforcement discretion with respect to the use of the term.

• “Dairy-free” and “Non-dairy”

The draft guidance confirms that the term “dairy-free milk” is not an adequate name for any plant-based milk alternative as it does not adequately name the plant-source and does not distinguish the product from other plant-based milk products. However, the term may be used as additional information on product labels to inform consumers.

Voluntary Nutrient Statements

• Recommended Nutrient Statement for Plant-Based Products Identified as “Milk”

As noted above, FDA is concerned that consumers may not understand the nutritional differences between milk and plant-based milk products, particularly as consumer research indicates that consumers view plant-based milk alternatives labeled with the term “milk” more favorably from a nutritional standpoint than similar products labeled with terms like “drink” or “beverage.” 

As such, FDA recommends that plant-based milk alternatives that use the term “milk” in their name (e.g., “soy milk,” “almond milk,” etc.), and have a nutrient composition that is different from milk, bear an additional, voluntary nutrient statement on the product label describing how the product is nutritionally different from cow milk. An example of such statement is, “Contains lower amounts of [nutrient name(s)] than milk.”

Similarly, FDA recommends that plant-based milk alternatives that use “beverage” or “drink” in their name (e.g., “almond beverage,”) and bear a relative claim comparing the product to milk (e.g., “50% more calcium than milk”) use a symbol next to the claim; the symbol would lead to a voluntary nutrient statement about other nutrients found in milk that are present in lower amounts in the plant-based milk alternative.

• Differentiating the Nutrient Composition of Plant-Based Milk from Milk

FDA recommends using USDA’s Food and Nutrition Service (“FNS”) nondairy beverages nutrient criteria (e.g., calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, and vitamin B12), shown below, to determine whether a plant-based product contains more or less of a particular nutrient than milk does.

* We note that USDA has issued a proposed rule to update the units of measure for vitamin A and vitamin D to align with how they are declared on the updated Nutrition Facts label, which is in micrograms.

• Location of the Voluntary Nutrient Statement

FDA recommends that the voluntary statement appear prominently on the product’s principal display panel (“PDP”) near and visually connected to the name of the product if space allows. Alternatively, a symbol (e.g., “†”) may be placed next to the name of the product that directs consumers to the voluntary nutrient statement on the principal display panel. The nutrient statement need not appear everywhere on the package that the plant-based milk name appears. 

• Claims Comparing Plant-Based Milk Products to Milk

Plant-based milk alternatives that contain similar or greater amounts of the USDA FNS nondairy beverages nutrients than milk may make such claims on their PDP (e.g., “contains 50% more calcium than milk” or “contains similar amounts of calcium as milk”).  In addition, truthful and not misleading statements about nutrients that are not listed in USDA’s FNS nondairy beverages nutrient criteria (e.g., “contains 20% more of the Daily Value for iron than milk”) are also permissible.

However, where a plant-based milk product contains lower amounts of other important nutrients found in milk that are identified in USDA’s FNS nutrient criteria (as shown in the chart above), FDA recommends including the voluntary nutrient statement discussed above.

• Sweetened Plant-Based Milk Products

With respect to plant-based milk alternatives that come in sweetened varieties, FDA notes that such alternatives often come in both sweetened and unsweetened varieties, and the amount of added sugar in the former can vary.  As such, FDA does not recommend that the added sugar content of plant-based milk alternatives that come in sweetened varieties appear in the voluntary nutrient statement.

• Application to Other Plant-Based Dairy Products

FDA’s voluntary nutrient statement recommendations do not apply to other plant-based dairy alternatives such as plant-based cheese, yogurt, or kefir.  The voluntary nutrient statement recommendations are limited to plant-based milk alternatives and are not intended apply to any other foods.

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FDA is accepting comments on the draft guidance until April 24, 2023. If you have any questions concerning the submission of comments for this draft guidance, please contact the members of our Life Sciences practice group.

[1] Press Release, U.S. Food and Drug Administration, “FDA Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers” (February 22, 2023), https://www.fda.gov/news-events/press-announcements/fda-provides-draft-labeling-recommendations-plant-based-milk-alternatives-inform-consumers.

[2] Mercer, Marsha, Pew Trusts, “Stop Milking It, Dairy Farmers Tell Plant-Based Competitors” (March 2, 2020), https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2020/03/02/stop-milking-it-dairy-farmers-tell-plant-based-competitors.