The Food and Drug Administration (“FDA”) recently issued guidance recommending that the term “milk” extend beyond dairy (cow) milk products to plant-based alternatives. Although not legally binding, the guidance indicates that nondairy milk alternatives can be labeled “milk” and need not be restricted as nondairy “beverages” or “drinks.” These plant-based alternatives should, however, include a statement on their product label describing how they are nutritionally different from milk (e.g., “contains a lower amount of potassium than milk”).

In September 2018, the FDA issued a notice requesting comments on plant-based milk product labeling, over 13,000 comments were submitted. Contrary to concerns over consumer confusion, the FDA found that the average consumer does not conflate dairy and nondairy milk products. Despite “milk” labels on plant-based milk alternatives, the FDA determined that consumers generally understand these alternatives are different than milk.

What consumers may not understand is the nutritional difference between the two. Over half of consumers surveyed indicate that they consider plant-based milk alternatives labeled “milk” to have similar nutritional content to milk. Research further showed that the majority of consumers who purchase plant-based alternatives do so under a mistaken belief that the products are healthier than milk. This misunderstanding is a “public health concern” and the impetus behind the new FDA guidance.

Milk is a well-documented source of nutrients and a key component of a healthy diet. Plant-based alternatives, however, have varying degrees of nutritional value depending on the type of alternative (e.g., almond versus oat) and various other factors (e.g., raw materials used, processing, addition of other ingredients). Consuming plant-based milk alternatives as a milk replacement, without the addition of other foods to supplement the missing nutrients, can lead to nutritional deficiencies and adverse health effects. 

To ensure that nutritional distinctions are not lost on consumers, the FDA’s proposed guidance includes a voluntary nutritional label that nondairy milk producers include on their products. These labels will display direct nutritional comparisons between the nondairy product and traditional dairy milk and indicate where the nondairy alternative lacks the caliber of nutrients that traditional dairy milk contains. For example, producers would indicate on a product label that the nondairy alternative contains lower amounts of calcium than dairy milk. The rationale behind such labeling is to ensure consumers have the opportunity to make fully informed dietary decisions. To compare nutritional similarities to milk, the FDA recommends using the Department of Agriculture’s (“USDA”) Food and Nutrition Service fluid milk substitute nutrient criteria.

Opponents of the new FDA guidance highlight the inherent dairy versus nondairy comparison shortcomings. Even dairy milk comes in various forms. Nondairy manufacturers could simply select a less nutritionally dense dairy milk option with which to compare their products. The potential manipulation and lack of coherence could create further confusion among consumers. Opponents have also ridiculed the FDA’s decision to deem dairy milk as the nutritional standard and superior option to nondairy alternatives. Contrary to the FDA’s findings, regular dairy milk consumption is no longer widely touted as the nutritional standard, and certain nutritional components in milk (e.g., protein and magnesium) are not lacking in the typical adult’s diet, which opponents argue could lead to overconsumption.

The guidance is for now just that―guidance. But the FDA has made clear that plant-based milk alternatives that act as a substitute for and resemble milk and are nutritionally inferior will be subject to FDA enforcement as an “imitation food” pursuant to Section 403(c) of the Federal Food, Drug, and Cosmetic Act. The FDA will consider comments on the draft guidance for 60 days from the date of its publication on February 23, 2023 before issuing a final version.