The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of plant-based products marketed and sold as alternatives to milk (plant-based milk alternatives, or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This draft guidance will provide industry with recommendations that will result in clear labelling, allowing consumers to make more informed purchasing decisions. It also clarifies that some PBMA’s common or usual names have been established by common usage, such as “soy milk” and “almond milk.”
Purpose of the Guidance:
The purpose of this guidance is to provide FDA’s current position on the naming of plant-based foods marketed and sold as milk substitutes (plant-based milk substitutes) in accordance with sections 403(a)(1) and 403(i)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(a)(1) and 343(i)(1)). Our recommendations on the use of voluntary nutrient statements are also included in the guidance. The use of these voluntary nutrient statements by the industry would provide consumers with additional nutrition information to assist them in understanding certain nutritional differences between these products and milk and making informed dietary choices.
In 2018, the FDA issued a notice seeking public feedback on how consumers use PBMA products and how they understand the term “milk” when it appears in the names of products made from soy, peas, and nuts. More than 13,000 comments were received by the agency.
FDA Comment Review:
Following a review of these comments and focus group studies with consumers, the FDA concluded that consumers generally understand that PBMA do not contain milk and choose PBMA because they are not milk. Many consumers, however, may be unaware of the nutritional differences between milk and PBMA products.
Almond or oat-based PBMA products, for example, may contain some calcium and be consumed as a source of calcium, but their overall nutritional content is not comparable to milk and fortified soy beverages, and thus they are not included in the dairy group in the Dietary Guidelines, 2020-2025. Both public comments and focus groups assisted the agency in developing its recommendations in this draft guidance.
The FDA recommends that PBMA products with the term “milk” in their names, such as “soy milk” or “almond milk,” and with a nutrient composition that differs from milk include a voluntary nutrient statement that conveys how the product compares to milk based on USDA’s Food and Nutrition Service (FNS) fluid milk substitutes nutrient criteria.
How will this assist customers?
These statements will assist consumers in making informed dietary choices by explaining certain nutritional differences between plant-based products labelled with “milk” in their names and milk. If a PBMA does not have “milk” in its name but is labelled with another term such as “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.
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.
For More Information:
- Draft Guidance for Industry
- Federal Register Notice
- Plant-Based Milk Alternatives (PBMA)
- Press Release: FDA Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers
- Consumer Update: Milk and Plant-Based Milk Alternatives – Know the Nutrient Difference
- Food Facts: Using the Nutrition Facts Label to Choose Milk and Plant-Based Beverages
How can Quality Smart Solutions serve you?
Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).
Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published.
Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Importer of Record Licensing, NDIN/GRAS Ingredients and GRAS Notifications).
Help with facility registration, FSVP agent, and US Agent.