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FDA Releases Plant Based Milk Draft Guidance

Specialty Food Association

The FDA issued today a draft guidance for comment to help ensure appropriate labeling of plant-based products that are marketed and sold as alternatives to milk.

The guidance intends to provide the industry with recommendations that will result in clear labeling to equip consumers with more information to make purchasing decisions. It also clarifies the common or usual names of some alternatives that have been established by common usages, like “soy milk” and “almond milk.”

The FDA recommends that alternative milk products that are labeled with the term “milk” in their names, and that have a nutrient composition that is different from milk, include a voluntary nutrient statement that conveys how the product compares with milk based on USDA’s Food and Nutrition Service fluid milk substitutes nutrient criteria.

This nutrient statement will help consumers understand and make informed choices regarding the nutritional differences between plant-based products labeled with “milk” and animal-derived milk. 

If a milk alternative is not labeled with “milk” as part of its name and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations in the draft guidance do not apply.

In 2018 the FDA issued a notice soliciting comments from the public to gain insight into how consumers use PBMA (plant-based milk alternative) products and how they understand the term “milk” when included in the names of products made, for example, from soy, peas, and nuts.

After reviewing over 13,000 comments and conducting focus group studies with consumers, the FDA determined that consumers generally understand that plant-based milk alternatives do not contain milk. However, many consumers may not be aware of the nutritional differences between milk and milk alternatives. For example, almond or oat-based milk products may contain some calcium and be consumed as a source of calcium, but their overall nutritional content is not similar to milk.

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register . You may submit electronic comments to Regulations.gov. All written comments should be identified with the docket number FDA-2023-D-0451 and with the title of the guidance document.

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