The Food and Drug Administration is reopening the public comment period on draft guidance for labels on plant-based “milk” products.

Federal officials say the new deadline for submitting comments will be determined when the reopening notice is officially published.

“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,” according to the agency.

The draft guidance is entitled “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry.” The draft was initially published in the Federal Register on Feb. 23 this year. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-0451.

The draft recommendations are for industry on the naming of plant-based beverages that are marketed and sold as alternatives to milk. The draft guidance also recommends voluntary nutrient statements for the labeling of some plant-based milk alternatives. 

“Today's draft guidance was developed to help address the significant increase in plant-based milk alternative products that we have seen become available in the marketplace over the past decade,” FDA Commissioner Robert Califf said when the draft guidance was published on Feb. 23. 

“The draft recommendations issued today should lead to providing consumers with clear labeling to give them the information they need to make informed nutrition and purchasing decisions on the products they buy for themselves and their families.” 

In addition to the increase in market availability and consumption, the variety of alternatives to dairy products has greatly expanded from soy, rice, and almond to include cashew, coconut, flaxseed, hazelnut, hemp seed, macadamia nut, oat, pea, peanut, pecan, quinoa and walnut-based beverages. Although these products are made from liquid-based extracts of plant materials, such as tree nuts, legumes, seeds, or grains, they are frequently labeled with names that include the term “milk.”

The draft guidance recommends that a plant-based milk alternative product that includes the term “milk” in its name such as “soy milk” or “almond milk,” and that has a nutrient composition that is different than dairy milk, include a voluntary nutrient statement that conveys how the product compares with dairy milk based on the U.S. Department of Agriculture's Food and Nutrition Service fluid milk substitutes nutrient criteria. For example, the label could say, “Contains lower amounts of Vitamin D and calcium than milk.” 

In September 2018, the FDA requested information on the labeling of plant-based milk alternatives (PBMA) with terms that include the names of dairy foods such as “milk.” More than 13,000 comments were received, and the FDA determined that consumers generally understand that PBMA does not contain dairy milk and choose to purchase PBMA because they are not dairy milk. 

However, according to the FDA, 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 calcium and be consumed as a source of calcium, but their overall nutritional content is not similar to dairy milk and fortified soy beverages, and they are not included as part of the dairy group in the Dietary Guidelines 2020-2025.

Dairy foods, including milk, are recommended by the Dietary Guidelines as part of a healthy eating pattern and contribute multiple key nutrients, including protein and vitamins A and B-12, along with calcium, potassium, and vitamin D, which are currently under-consumed, according to federal studies. The Dietary Guidelines only include fortified soy beverages in the dairy group because their nutrient composition is similar to that of dairy milk. However, the nutritional composition of PBMA products varies widely within and across types, and many PBMAs do not contain the same levels of key nutrients as milk. 

“Getting enough of the nutrients in milk and fortified soy beverages is especially important to help children grow and develop, and parents and caregivers should know that many plant-based alternatives do not have the same nutrients as milk,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition. “Food labels are an important way to help support consumer behavior, so we encourage the use of the voluntary nutritional statements to better help customers make informed decisions.” 

To support consistency across federal nutrition policies, the draft guidance recommends that the industry use the USDA’s Food and Nutrition Service fluid milk substitutes nutrient criteria to determine if a PBMA is nutritionally similar to dairy milk. Also, the FDA encourages consumers to use the Nutrition Facts label to compare the nutrient content of different products to help make informed choices.

The draft guidance does not apply to other plant-based dairy alternatives, such as plant-based cheese or yogurt alternatives. The FDA is in the process of developing a draft guidance to address the labeling and naming of other plant-based alternative products and will communicate updates when available.