FDA issues draft guidance on labeling plant-based milk alternatives: top points

On February 22, 2023, FDA released its Draft Guidance for Industry: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements (PBMA), which provides the food industry long awaited guidance on the labeling of plant-based milk alternatives.

The draft guidance was issued more than four years after FDA first sought comments and information from industry.

The PBMA Draft Guidance sets forth several key takeaways, including:

• FDA concluded that consumers generally understand that plant-based alternatives are not dairy and do not contain milk.  However, the agency expressed some concern that consumers may be confused or unaware that the nutritional profile of plant-based alternatives differs from dairy milk.
  
  
• The term “milk” may be used in the common or usual name for plant-based milk alternatives, but it should be qualified by the plant source of the food.  Generic product names such as “plant based milk” or “dairy-free milk” may not be appropriate as they do not describe the particular source of the food.  Truthful terms such as “dairy free” may be used on broader labeling.
  
  
• The term “milk,” may be used in the labeling of a plant-based alternative product as a single word, multiple words, or hyphenated words (eg, soymilk, soy milk, or soy-milk).
  
  
• For blended products, the different plant sources should be included in the name so that sources can identify the nature of the food (eg, walnut and cashew milk, walnut milk with cashew milk, 7 Grain Plant-Milk Blend)
  
  
• While the term “milk” may be used appropriately, it is still permissible to refer to these products in other ways, such as “beverage” or “drink.”
  
  
• For plant-based milk alternatives that use the term “milk” in their name – and that have a nutrient composition different from milk (eg, calcium, protein, Vitamin A) – FDA recommends including a voluntary nutrient statement that communicates how the product is nutritionally different from dairy milk (eg, “Contains lower amounts of [nutrient name(s)] than milk.”).  FDA recommends placing the voluntary nutrient statement on the principal display panel near and visually connected to the name of the product if space allows. A symbol can also be placed next to the name of the product, and across product name statements appearing outside of the PDP, that directs consumers to the voluntary nutrient statement on the PDP.  To determine if a plant-based milk alternative is nutritionally different than milk, FDA recommends using USDA’s FNS fluid milk substitutes nutrient criteria.
  
  
• If plant-based milk alternatives make relative claims comparing to milk (eg, “50% more calcium than milk”), FDA recommends using a voluntary nutrient statement or a symbol directing consumers to the voluntary nutrient statement on the PDP.  Those voluntary nutrient statements should be as prominent on the label as the relative claim.

To reiterate a key point, the referenced nutritional disclosure statement is voluntary.  While the Draft Guidance recommends the voluntary disclosure, the disclosure is not mandatory and may prove burdensome for the industry while not serving consumer needs.  For example, not all nutrients in milk are of “potential public health concern of underconsumption” and consumers may be consuming traditional dairy for those purposes.  

This draft guidance reflects one of many policy issues the agency will need to consider as food technology advances.  As more products are developed that seek to replace traditional foods, the agency will need to grapple with how these products are labeled to ensure consumers are not misled, as well as ensuring that any decisions do not stifle innovation in the food industry.

FDA is accepting comments on the PBMA Draft Guidance until April 24, 2023.