Earlier this week, the U.S. Food and Drug Administration (FDA) issued draft guidance, “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry,” for the labeling of plant-based products that are marketed and sold as alternatives to milk, called plant-based milk alternatives (PBMAs).

The draft guidance is part of the FDA’s ongoing Nutrition Innovation Strategy and, more specifically, its initiative to modernize its food standards of identity. Fifty years ago, the FDA established a definition and standard of identity for products labeled as “milk,” which (among other things) provides that “milk” refers to products obtained from cows. In the intervening years, a variety of concerns, including animal welfare, human health, environmental sustainability, and religious beliefs, have been leading an increasing number of consumers to limit their intake of animal-derived food products. In the dairy aisle, this trend has been reflected in a plethora of milk alternatives, such as soy milk, oat milk, almond milk, and coconut milk. Although these products are often packaged in the same kinds of cartons, tubs, or bottles as their dairy counterparts and sometimes are sold in or adjacent to the dairy display, they may not have the same basic nature, nutritional profile, or performance characteristics (e.g., physical properties, flavor characteristics, functional properties, or shelf life). For this reason, in 2018, the FDA solicited feedback from stakeholders on the labeling of PBMAs.

In response to the comment request, the FDA received more than 13,000 comments which have informed the new draft guidance. The draft guidance sets forth recommendations that are intended to yield clear labeling to “empower consumers with information to help them make more informed purchasing decisions.” In particular, the FDA is recommending that PBMA products that incorporate the term “milk” in their names but differ from cow’s milk in nutrient composition include a voluntary nutrient statement that conveys how the product compares with cow’s milk. The FDA believes that these statements will “help consumers make informed dietary choices.” If a PBMA is not labeled with “milk” as part of its name, but instead is labeled with another term like “beverage” or “drink” and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations in the draft guidance will not apply.

It is notable that the FDA has declined to adopt the position advanced by some stakeholders that PMBAs should not use the term “milk” in their statements of identity. Rather, the draft guidance clarifies the FDA’s view that that the common or usual names of some PBMAs, including soy milk and almond milk, have been established by common usage. The FDA added that “the comments and information [it] reviewed indicate that consumers understand plant-based milk alternatives to be different products than milk” and that consumers “do not mistake plant-based milk alternatives for milk.” Moreover, the FDA recognizes that First Amendment considerations limit the agency’s ability to prohibit the use of the term “milk” in contexts that are not false or misleading. The FDA is particularly cognizant that some courts have struck down state-level efforts to ban the use, on plant-based alternative products, names associated with meat and/or dairy products, although permitting states to require prominent disclosure indicating that a product is plant-based. The plant-based alternative food industry will, no doubt, be watching closely to see if the FDA’s decision to permit the use of the term “milk” in the statements of identity for PBMAs will have larger implications for the marketing of novel plant- and cell-based alternative foods.

Wilson Sonsini provides cross-functional legal support to help companies navigate complex legal issues in connection with regulation reform. For more information, please contact Georgia Ravitz, Jamie Ravitz, Eva Yin, or Paul Gadiock in the firm’s FDA regulatory, healthcare, and consumer products practice, Maya Skubatch in the patents and innovations practice, or James Huie in the corporate practice.