In addition to the increase in market availability and consumption, the variety of alternative products available in the marketplace has also 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The draft guidance, "Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry," recommends that a plant-based milk alternative product that includes the term "milk" in its name (e.g., "soy milk" or "almond milk"), and that has a nutrient composition that is different than milk, include a voluntary nutrient statement that conveys how the product compares with milk based on the U.S. Department of Agriculture's (USDA) 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 do not contain milk and choose to purchase 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 calcium and be consumed as a source of calcium, but their overall nutritional content is not similar to 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. The Dietary Guidelines only includes fortified soy beverages in the dairy group because their nutrient composition is similar to that of 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.

The FDA is accepting comments on the draft guidance. A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final.

Joseph Scimeca, Ph.D., senior vice president of regulatory and scientific affairs for the International Dairy Foods Association (IDFA), issued the following statement regarding the proposed guidelines:

“It is important that consumers are provided with accurate information about the nutrient profiles of plant-based alternatives so that they have science-based, accurate information to decide for themselves and their families about what’s best for their diet and nutritional needs, including how the nutrients in plant-based alternatives compare to the well-established nutrient package of cow’s milk. It has been IDFA’s consistent position that it is the responsibility of the FDA to ensure product names and claims made by manufacturers of plant-based products adhere to long-standing FDA food labeling policy that label statements must be truthful and not misleading to consumers. At the same time, it is incumbent on FDA to provide verification and enforcement of voluntary claims and statements to ensure consumers are receiving accurate nutritional information and can compare the nutritional values of plant-based alternatives to traditional cow’s milk products. As we continue to review today’s draft guidance to industry and begin to consider formal comments within the 60-day comment period, IDFA will seek to ensure this draft guidance clears up any longstanding confusion about the nutritional quality of plant-based beverages. It is incumbent on FDA to get this policy right. IDFA will closely review and question how the FDA plans to enforce this draft guidance to ensure information provided by companies to consumers is truthful and not misleading and enables consumers to compare the nutritional value of plant-based alternatives to their traditional cow’s milk counterparts. As FDA’s consumer research demonstrates, consumers lack clarity as to the nutritional differences of plant-based alternatives versus traditional dairy counterparts and the agency must promulgate guidance that not only adheres to its own standards of truthful and not misleading but also advances the nutrition security of Americans.”

Edge Dairy Farmer Cooperative President Brody Stapel added, “The co-op is looking forward to working with the FDA and Administrator Dr. Robert Califf by providing comments to express the importance of accurate labeling of plant-based milk alternatives for consumers and farmers. Accurate labeling of imitation dairy products, especially milk, has frustrated dairy farmers for far too long. The nutritional benefits of dairy products are superior to imitation products, and consumers should be well-informed using proper labeling and terms. Dairy foods, including milk, are part of a healthy eating pattern and provide consumers with healthy and nutritious food options.”