On April 20, The FDA announced that it will reopen the comment period for the draft guidance “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry” in response to requests from stakeholders to allow additional time for interested persons to develop and submit comments.
The draft guidance, originally published in the Federal Register on February 22, 2023, was developed to help ensure appropriate labeling of plant-based products that are marketed and sold as alternatives to milk (aka plant-based milk alternatives, or PBMA). It provides industry with recommendations for clear labeling to help consumers 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. The goal is to 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and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations in the draft guidance would not apply.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.
In its statement announcing the draft guidance, the FDA noted that, after reviewing these comments and conducting focus group studies with consumers, it determined that consumers generally understand that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.
Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-0451.