FDA issues draft guidance on labeling of plant-based milk alternatives

Background

In recent years, there has been a dramatic increase in the sale¹ and consumption of plant-based milk alternatives.² Although there is a standard of identity established for milk,³ FDA has not established a corresponding standard of identity or compositional requirements for plant-based milk alternatives.  To provide additional clarity in the labeling of these products, in September 2018, FDA issued a notice requesting public comment on “the labeling of plant-based products with names that include the names of dairy foods such as ‘milk,’ ‘cultured milk,’ ‘yogurt’ and ‘cheese’”,⁴ and received more than 13,000 comments.  These comments “helped to inform the development of this draft guidance,” which is outlined below.

Draft Guidance Content

Consumer Perceptions of Plant-Based Milk Alternatives

FDA explains that consumer research indicates consumers generally do not mistake plant-based alternatives for milk. One such study found that “about three-quarters of its respondents understood that plant-based milk alternatives do not contain milk; fewer than 10 percent believed that plant-based milk alternatives do contain milk, and the remainder did not know.”

FDA also cites the results of its own focus groups, which indicated most participants were not confused about plant-based milk alternatives containing milk and refer to plant-based milk alternatives as “milk.”⁵ Other key points from this research include that participants view the names “beverage” and “drink” (e.g., “almond beverage”) as potentially suggesting a lower quality than a product called “milk”; and that consumers understand that plant-based milk alternatives are distinct from milk and choose to purchase them because they are not milk.

FDA finds, however, that some research suggests consumers do not understand the nutritional differences between plant-based milks and milks, with some consumers believing the plant-based alternatives are healthier than milk or have a nutritional content similar to milk.

Nutritional Differences

FDA cites the fact that the Dietary Guidelines for Americans 2020-2025 (DGA) includes soy beverages and soy yogurt alternatives fortified with calcium, vitamin A, and vitamin D in the Dairy Group based on their similar nutrient compositions and use in meals. However, the DGA also states that other plant-based milk alternatives, such as those made from almond, rice, coconut, and hemp, may contain calcium, “but they are not included as part of the dairy group because their overall nutritional content is not similar to dairy milk and fortified soy beverages.”  FDA cites analysis in the 2015 and 2020 Dietary Guidelines Advisory Committee (DGAC) reports on the lack of potentially important nutrients (e.g., protein, magnesium, phosphorus, and potassium) in plant-based milk alternatives. FDA concludes that “consistently consuming plant-based milk alternatives that do not have a similar nutritional composition to milk in place of milk, without the addition of other foods to supply the missing nutrients, could lead to further inadequate intakes of nutrients of public health concern and other nutrients that pose a special public health challenge.”

FDA Recommendations for Labeling Plant-Based Milk Alternatives

In the guidance, FDA provides questions and answers regarding 1) naming principles for plant-based milk alternatives and 2) recommendations for voluntary nutrient statements.

Naming of Plant-Based Milk Alternatives

• Common or Usual Name: Under the Federal Food, Drug and Cosmetic Act (FFDCA) and FDA regulations, “non-standardized foods,” or foods that do not have a standard of identity, must be labeled using the common or usual name, which can be established through regulation or common usage.⁶ In the draft guidance, FDA recognizes that soy milk and almond milk are established as common or usual names based on common usage. FDA also states that names that use the term “beverage” or “drink”, e.g., “soy beverage” are used less frequently, but are also in common usage.
  • FDA also discusses that “plant-based milk” or “dairy-free milk” are insufficiently descriptive and the plant source should be identified in the name.
• Imitation Food Labeling: The FFDCA and FDA regulations also provide for “imitation” labeling for a food that “is a substitute for and resembles another food but is nutritionally inferior to that food.”  In the draft guidance, FDA recognizes that not all plant-based milk alternatives meet the definition of an imitation food, but to the extent they do, the agency intends to exercise enforcement discretion with respect to the imitation foods labeling regulation.  This is based on FDA’s findings that consumers generally understand that plant-based alternatives and milk are distinct products, and that they purchase these products because they are not milk.  Both of these factors reinforce that these foods do not raise the historic concern underlying the imitation foods labeling requirement, which was to protect consumers from an “uninformed purchase of an inferior substitute product which could be mistaken for a traditional food product.”
• “Dairy-Free” or “Non-Dairy”: In the draft guidance, FDA encourages the labeling of products as dairy free or non-dairy when the terms are used to educate consumers in a truthful and not misleading manner, but does not offer a definition of either term. 

Voluntary Nutrient Statements

FDA recommends that plant-based milk alternatives that use “milk” in the name (e.g., “soy milk”), and that have different nutrient compositions from milk, bear a “voluntary nutrient statement” on the product label describing how it is nutritionally different.  One example of a possible disclosure is “Contains lower amounts of [nutrient name(s)] than milk”, placed on the principal display panel (PDP), either next to the product name, or elsewhere on the PDP with an asterisk next to the statement and the product name. 7

• Covered Products:  Generally, plant-based milk alternatives that are not labeled with the term “milk” and that instead are named using terms like “beverage” or “drink”, are not subject to the voluntary statements, unless they bear a relative claim comparing the product to milk (e.g., “50% more calcium than milk”).  The voluntary statements do not apply to other plant-based dairy alternatives such as plant-based cheese, yogurt, or kefir alternatives. 
• Nutrient Differences: To determine whether a plant-based milk alternative has a nutrient composition that is different from milk, the guidance recommends the use of the U.S. Department of Agriculture (USDA) Food and Nutrition Service (FNS) Fluid Milk Substitutes Nutrient Criteria, which is summarized at Appendix A.⁸ The covered nutrients include calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, and vitamin B12.
  • Magnesium:  FDA recognizes that magnesium is listed in the FNS criteria, and is recommending that when a plant-based milk alternative has a lower amount of magnesium than milk, companies should use the disclosure, even though magnesium is not an under-consumed nutrient.
  • Added sugars: FDA’s recommendations do not include a disclosure related to added sugars content.
• Relative Claims: The draft guidance recognizes it is appropriate to use relative nutrient-content claims comparing plant-based milk alternatives to milk.  However, if the plant-based alternative milk contains lower amounts of the nutrients discussed above than milk, FDA recommends the use of a voluntary nutrient statement or symbol leading to a voluntary nutrient statement on the PDP.⁹

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Why it matters:  The draft guidance has been in the works for almost 5 years, since then-FDA Commissioner Dr. Scott Gottlieb stated that “an almond doesn’t lactate” and expressed possible concerns about the labeling of plant-based milks based on the levels of nutrients like vitamin D and protein in some products compared to milk.¹⁰ The draft guidance reflects these concerns in its recommendations, while balancing consumer perceptions of the plant-based milk alternatives category.

In addition, although FDA carves out other plant-based alternative foods from the draft guidance, we can anticipate that FDA may consider similar principles when issuing its separate forthcoming draft guidance on the labeling of such products.¹¹ We understand FDA expects to publish this draft guidance in summer 2023.

Next Steps

Comments on the draft guidance are due April 24, 2023. The draft guidance does not include a recommended timeline for adding the voluntary statements. We encourage trade associations and companies to submit comments to FDA and are available to assist.

Click here to view Appendix A.

Click here to view Appendix B.

Authored by Elizabeth Fawell, Veronica Colas, and Molly Mulligan.

References

1 According to FDA, from 2016 to 2020, sales totals for plant-based milk alternatives increased from $1.5 billion to $2.4 billion. FDA, “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry,” p. 4 (February 2023), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-labeling-plant-based-milk-alternatives-and-voluntary-nutrient-statements.

2 FDA noted the variety of these products has also expanded in recent years from soy, rice and almond to include, among others, “cashew, coconut, flaxseed, hazelnut, hemp seed, macadamia nut, oat, pea, peanut, pecan, quinoa, and walnut-based.” See Id.

3 See 21 CFR 131.110.

4  See 83 Fed. Reg. 49103 (Sept. 28, 2018).

5 In fact, FDA states “‘milk’ is strongly rooted in the consumers’ vocabulary when describing and talking about plant-based milk alternatives.”  Draft Guidance at p. 5.

6 21 U.S.C. 343(i)(1); 21 CFR 101.3(b); 102.5(a).

7 See Appendix A for examples of the voluntary nutrient statement. FDA recommends that this symbol is used each time the name appears on the label.

8  See Appendix B.

9 See Appendix A for an example of a relative claim on the PDP.

10 Gottlieb: FDA to crack down on labelling nondairy products, Politico, July 17, 2018, https://www.politico.com/story/2018/07/17/almond-lactate-nondairy-milk-scott-gottlieb-725974; Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes, September 27, 2018, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-modernizing-standards-identity-and-use-dairy-names; Remarks by Dr. Gottlieb at the Public Meeting on FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy, July 26, 2018, available at https://www.fda.gov/news-events/speeches-fda-officials/remarks-public-meeting-fdas-comprehensive-multi-year-nutrition-innovation-strategy-07262018.

11 Foods Program Guidance Under Development (updated June 2022), https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development (indicating FDA intends to issue a draft guidance titled Labeling of Plant-Based Alternatives to Animal-Derived Foods).