This draft guidance comes after a notice for comment in late 2018 where the FDA solicited comments on labeling of plant-based alternatives with names that include the names of dairy foods. Since that comment period, the market availability of PDMAs has continued to increase, alongside the variety of predominant ingredients in these PDMAs (e.g., flaxseed, coconut, hemp seed, oat, pea, quinoa, and walnut). Up until this point, the FDA has not established compositional requirements for PDMAs. This draft guidance is only applicable to PDMAs and not other plant-based alternatives such as plant-based meats and cheeses.

The key takeaways from the draft guidance:

• “Milk” is strongly rooted in consumers’ vocabulary when describing and talking about PDMAs and consumers understand that PDMAs are distinct products from milk (based on consumer survey data).
• Studies indicate that consumers are confused about the nutritional differences between milk and PDMAs.
• PDMAs are not required to be labeled as “milk,” and can also be labeled with the term “beverage” or “drink.” FDA does not prohibit the use of the term “milk” on a PDMA so long as the plant-based source is identified.
• Use of the term “plant-based milk” (and not identifying the source of the plant-based) is not an appropriate name for PDMAs, and the drink label should include what the predominant ingredient is (e.g., almond milk, soy milk, etc.).
  • If there is a mix of predominant ingredients, both should be included on the label, with the more prevalent ingredient listed first (e.g., Walnut & Cashew Milk, assuming walnut is the predominant ingredient).
• The FDA does not intend to enforce regulations regarding imitation foods (found at 21 C.F.R.§ 101.3(e), despite the fact that certain PDMAs fall under the definition of an imitation food because consumers generally understand that milk and PDMAs are distinct products.
• While PDMAs may include truthful claims about being “dairy-free” on their labels, the term “dairy-free milk” on its own is inadequate because it fails to describe the nature of the plant source.
• The FDA recommends that PBMAs that use the term “milk” and have a different nutrient composition than milk bear an additional, voluntary nutrient statement on the product describing how it is nutritionally different.
  • The voluntary nutrient statement should address the following nutrients: Calcium, Protein, Vitamin A, Vitamin D, Magnesium, Phosphorus, Potassium, Riboflavin, and Vitamin B12.
  • In comparing the nutritional differences between milk and the PDMA, manufacturers should use USDA’s Food and Nutrition Service (“FNS”) fluid milk substitute nutrient criteria, listed on page 29 of the draft guidance document.
  • The FDA recommends that the voluntary statement be something like “Contains lower amounts of [nutrient name(s)] than milk.”
  • The FDA recommends that the voluntary statement be displayed on the principal display panel (“PDP”) and visually connected to the name of the product. A symbol could be placed next to the name of the product which directs consumers to the statement. If the name of the product, such as “Almond Milk,” is displayed multiple times on the label, each instance need not necessarily direct the consumer to the voluntary nutrient label if the statement or a symbol appears on the PDP.PDMAs may make truthful and non-misleading comparison claims to milk regarding nutrients not identified in the FNS fluid milk substitute nutrient criteria (e.g., 50% more calcium than milk).
  • If a PDMA is labeled as a “drink” or “beverage” instead of “milk,” but makes a comparison claim to milk, the FDA recommends it still include the voluntary nutrient statement as well.
  • If the PDMA is sweetened, the FDA does not recommend including the added sugars in the voluntary nutrient statements.

The FDA is accepting comments on the draft guidance. Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register. Electronic comments can be submitted to Regulations.gov. All comments should be identified with the docket number FDA-2023-D-0451.

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