On February 22, 2023, the U.S. Food and Drug Administration (FDA) released the Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry (hereinafter the Guidance) for public comment. This Guidance provides FDA's current thinking on naming plant-based foods marketed as milk substitutes, also known as plant-based milk alternatives (PBMA) and gives advice on using voluntary nutrition statements. Notably, the Guidance doesn't have the force of law and only intends to clarify existing requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Background
The supply and consumption of plant-based milk alternatives (PBMA) in the market have been increasing over the past years. In 2016, one in three U.S. households purchased or consumed PBMA products. Consumers' reasons for purchasing such products include but are not limited to allergy or intolerance to milk, religion, etc. In addition, PBMA products are used in ways similar to milk, such as in cereal, coffee, and smoothies. While some PBMA products have labels like "beverage" or "drink", most still have "milk" in the product name.
U.S. FDA also found that most consumers are aware that plant-based milks do not contain milk. However, if brands simply claim their products as plant-based milks without providing enough information about their ingredients, even if consumers clearly know it's not milk, they will still be confused about the ingredients, especially those who want to avoid ingredients such as nuts because of allergies. Crucially, FDA has yet to establish ingredient requirements for PBMA products. The composition of these products, including their nutritions, varies by plant source, processing method and added ingredients.
Proposed Suggestions
The term "milk"
According to the FD&C Act, PBMA products cannot be named as "milk". However, they are allowed to include the term "milk" as part of their names, e.g., soy milk.
Food identity
PBMA products are non-standardized foods, for the definition and standard of identity have not been established. Therefore, PBMA products must be labeled with their common or usual name, or, in the absence of a name, an identity statement that accurately describes the food. For example, using "soy milk" or "almond milk" to show its identity.
Voluntary nutrient statements
FDA recommends enterprises to use voluntary nutrient statements on PBMA products, which include the term "milk" (e.g., "soy milk," "almond milk," "oat milk," "almond-macadamia milk blend," etc.) and have a nutrient composition that is different than milk (e.g., calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, or vitamin B12). The move is intended to include additional nutritional claims on product labels to explain nutritional differences between PBMA products and milk.
Notably, this Guidance does not cover other types of mammalian milk, such as goat milk, sheep milk, and camel milk, which may be used as substitutes for milk. These types of milk are used as milk substitutes far less frequently than PBMA, so they are also less likely to have health problems due to their lower nutritional content than milk.
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