FDA Releases Draft Guidance on Labeling of Plant-Based Milk Alternatives

What’s New

April 20, 2023

The U.S. Food and Drug Administration (FDA) will reopen the comment period for the draft guidance entitled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry,” that appeared in the Federal Register on February 23, 2023. The new deadline for comments will be determined when the reopening notice publishes. The FDA is reopening the comment period in response to requests from stakeholders to allow additional time for interested persons to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-0451.

Constituent Update

February 22, 2023

Today, the U.S. Food and Drug Administration (FDA) issued, for comment, draft guidance to help ensure appropriate labeling of plant-based products that are marketed and sold as alternatives to milk (plant-based milk alternatives, or PBMA). This draft guidance will provide industry with recommendations that will result in clear labeling to empower consumers with information to help them make more informed purchasing decisions. It also clarifies that the common or usual names of some PBMA have been established by common usage, and these names include “soy milk” and “almond milk.”

The FDA recommends that PBMA products that are labeled with the term “milk” in their names, such as “soy milk” or “almond milk,” and that have a nutrient composition that is different than milk, include a voluntary nutrient statement that conveys how the product compares with milk based on USDA’s Food and Nutrition Service (FNS) fluid milk substitutes nutrient criteria. These statements will help consumers make informed dietary choices when it comes to understanding certain nutritional differences between plant-based products that are labeled with “milk” in their names and milk.  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and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations in the draft guidance do not apply.

In 2018 the FDA issued notice soliciting comments from the public to gain insight into how consumers use PBMA products and how they understand the term “milk” when included in the names of products made, for example, from soy, peas and nuts. The agency received more than 13,000 comments.

After reviewing these comments and conducting focus group studies with consumers, the FDA determined that consumers generally understand that PBMA do not contain milk and choose PBMA because they are not milk. However, many consumers may not be aware of the nutritional differences between milk and PBMA products. For example, almond or oat-based PBMA products may contain some calcium and be consumed as a source of calcium, but their overall nutritional content is not similar to milk and fortified soy beverages and thus they are not included as part of the dairy group in the Dietary Guidelines, 2020-2025. Both the public comments and focus groups helped inform the agency on its recommendations in this draft guidance.

To Submit Comments:

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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