On February 22, 2023, the Food and Drug Administration (FDA), released draft guidance regarding the labeling of plant-based milk alternatives.

The draft guidance, which provides industry with guidance on labeling plant-based milk alternatives, was released 4 years after the FDA published a notice seeking comments on the topic.

What is The Purpose of The Proposal?

To provide industry with recommendations for naming and voluntary nutrient statements for plant-based milk alternatives (PBMAs).

Scope

Use of the term “milk”
By the FDA’s 1973 definition, milk is: “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows”.
Because plant-based milk alternatives do not meet this definition, they fall subject to USDA’s Food and Nutrition Service standards for fluid milk substitutes and must contain a minimum amount of calcium, protein, vitamin A, vitamin D, magnesium, phosphorus, potassium, riboflavin, and vitamin B-12. PBMAs must use a statement of identity that accurately qualifies the use of the term “milk” – i.e. “soy milk”, or “cashew milk”.

Naming & Nutrient Statements

• Identity & Names
  • Should qualify the term “milk” with “soy”
  • Can be labeled as beverage, drink, or milk
  • Companies should not use the phrase “Plant-based milk” because is not a usual name for a PBMA, nor does it provide information as to the source of the “plant”
  • Blends should be listed with the predominant plant source stated first, e.g. “walnut-cashew milk)
  • The FDA recommends not referring to a PBMA as an “imitation” product because by their definition this refers to an inferior substitute
  • The FDA also recommends refraining from using “dairy-free” milk when referring to plant-based milk as these products already exist and could confuse the consumer
• Voluntary Nutrient Statements
  • FDA recommends adding a voluntary nutrient statement on plant-based milk product labels to describe how it is nutritionally different
  • FDA recommends using USDA’s FNS fluid milk substitute nutrient criteria to determine the differences between milk and a plant-based milk alternative
  • Any alternatives containing the name “milk” should list which nutrients have lower amounts than dairy milk and by how much
  • All voluntary nutrient statements should be included in the principal display panel and visually connected to the name of the product if space allows. A symbol (e.g., “†”) may be used to direct consumers to the voluntary nutrient statement. The FDA also recommends listing the voluntary nutrient statement on the food label
  • Manufacturers may also make statements about other nutrients that are not in USDA’s FNS nondairy beverages nutrient criteria. E.g. contains 20% more of the Daily Value for iron than milk”

Industry Response

The qualifying word in front of “nutrient statement” is “voluntary”, meaning discretion is being left up to the manufacturer whether or not they choose to label their PBMAs with a nutrient statement. This voluntary guidance was immediately met with pushback from the dairy industry, most notably by a proposed bi-partisan bill dubbed the “DAIRY PRIDE Act” which would prohibit products made from nuts, seeds, plants, and algae from using the term milk.

What Does This Mean for Industry?

To be determined. The draft guidance has yet to be implemented and the FDA is currently accepting comments. We recommend anyone who is looking to follow this topic keep an eye on FDA updates from us.

This article provides a supplemental review of the FDA statement titled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry”, and is not a substitute for reading the complete draft guidance document.

This draft document remains open for consultation until April 24, 2023.

For more information about this article, or any other regulatory affairs matters, please contact us.