New draft guidance from the Food and Drug Administration recommends voluntary nutrient statements to spell out the differences between milk and plant-based alternatives. 

FDA Commissioner Robert Califf said the draft guidance was developed to help address the proliferation of milk alternatives in the past decade and prevent consumer confusion about the nutritional differences.

"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," Califf said. 

The draft guidance recommends plant-based alternatives using the term "milk" — "soy milk" or "almond milk," for example — include a voluntary statement that conveys how the product's nutrients compare with milk. The statements to disclose differences would be based on fluid milk substitutes criteria spelled out by USDA's Food and Nutrition Service. As an example, FDA suggested a label could say, "Contains lower amounts of vitamin D and calcium than milk."

The guidance does not address plant-based alternatives to other dairy products like cheese or yogurt; the agency said it is "in the process of developing" draft guidance for "other plant-based products and will communicate updates when available."

The National Milk Producers Federation, a dairy producer trade association, has been among the leaders in the labeling transparency debate and has long sought to limit the use of terms like "milk" strictly to dairy products. In a statement, NMPF President and CEO Jim Mulhern said the announcement is a “step toward integrity for consumers of dairy products, even as it falls short of ending the decades-old problem of misleading plant-based labeling using dairy terminology.”

Current FDA regulations define dairy products as being from dairy animals, and NMPF has argued the expanded use of labeling as “milk” by alternatives has diluted the understanding of dairy milk’s nutritional differentiation. FDA stated the variety of alternative products available in the marketplace 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.

Mulhern said FDA’s “decision to permit such beverages to continue inappropriately using dairy terminology violates FDA’s own standards of identity, which clearly define dairy terms as animal-based products.”

In September 2018, FDA received more than 13,000 comments on a request for information on the labeling of alternative dairy products. FDA said it determined consumers generally understand the products do not contain milk, but may not be aware of the nutritional differences.

FDA noted the federal Dietary Guidelines for Americans only include fortified soy beverages in the dairy group because their nutrient composition is similar to that of milk. “However, the nutritional composition of (plant-based milk alternative) products varies widely within and across types, and many PBMAs do not contain the same levels of key nutrients as milk,” FDA said.

"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," she added.

Mulhern stated after four decades of efforts “that have fallen on deaf ears,” NMPF appreciated the work to elevate plant-based beverage labeling on the critical issue of nutrition. “As the agency entrusted with protecting consumers from mislabeled products, FDA’s action here takes a step in that direction,” he said.

But, Mulhern added, “We reject the agency’s circular logic that FDA’s past labeling enforcement inaction now justifies labeling such beverages as ‘milk’ by designating a common and usual name. Past inaction is poor precedent to justify present and future inaction.” 

The International Dairy Foods Association, which represents dairy processors, also plans to keep a close eye on how FDA implements the draft guidance. Joseph Scimeca, IDFA's senior vice president of regulatory and scientific affairs, said it will be incumbent for FDA to provide verification and enforcement of the claims and follow science in doing so. 

"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," Scimeca said. "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.” 

Madeline Cohen, Good Food Institute senior regulatory attorney, criticized the draft guidance and said it imposes new burdens on plant-based beverage makers. “The guidance is premised on the idea that consumers are somehow confused by plant-based milks’ nutrition, despite the fact that FDA already requires key nutrients to be included on the Nutrition Facts panel,” she said. 

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Cohen added, “The guidance compares plant-based milks to one standardized milk product even though FDA has never required any particular nutrient content for cow’s milk. Milks such as unfortified skim milk and 2% reduced-fat chocolate milk have significant nutritional differences from whole cow’s milk, yet these products are not required to note them on front-of-pack labels. Moreover, the guidance urges disclosures about nutrients that are not under-consumed by Americans, such as magnesium, and even nutrients that are overconsumed by some groups, such as protein. This approach incentivizes companies to use less descriptive terms, such as ‘drink’ or ‘beverage’—which FDA recognizes are unappealing to consumers—rather than well-understood and consumer-preferred terms like ‘oat milk.’”

NMPF said it will continue to work with Congress to pass a long-standing legislative priority: the bipartisan Defending Against Imitations and Replacements of Yogurt, milk, and cheese to Promote Regular Intake of Dairy Everyday (DAIRY PRIDE) Act. The bill would require the FDA to issue guidance for nationwide enforcement of mislabeled plant-based products within 90 days and require the FDA to report to Congress two years after enactment to hold the agency accountable for this update in their enforcement obligations.

Lead authors of the bill, Sens. Tammy Baldwin, D-Wis., and Jim Risch, R-Idaho, slammed what they called an “anti-dairy guidance” from FDA. The pair also pledged to reintroduce their bill since “FDA is failing to enforce its own definitions for dairy terminology and stop imitation products from deceiving consumers.”

FDA will take comments on the draft guidance, but the agency said a manufacturer may choose to implement the recommendations in the draft guidance before it becomes final.

In an email to Agri-Pulse, Rachel Dreskin, CEO of the Plant Based Foods Association, said they see many suggestions in this proposal that are "unfairly burdensome to companies, and frankly, treat plant-based products differently than any other foods in the market." Dreskin said PBFA looks forward to sharing its feedback with FDA in the coming weeks to ensure the best outcome for its members, industry, and for consumers "looking for options that align with their needs and values.”

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