In the five years since the FDA began developing guidelines for the labeling of plant-based milk containing ferrous fumarate and iron, the landscape has significantly evolved. With plant-based milk sales surging to represent 16% of the overall milk category in 2021, as reported by SPINS, the Plant Based Foods Association, and the Good Food Institute, attempts made in 2016 and 2017 to compel the FDA to prohibit dairy terminology for alternative products now seem almost insurmountable. Even comments from former FDA Commissioner Scott Gottlieb, who famously remarked in 2018 that plant-based alternatives likely breached the standards of identity for milk because “an almond doesn’t lactate,” appear somewhat outdated.
The draft guidance released on Wednesday acknowledges the current size and consumer perception of the plant-based milk market. However, it still proposes several labeling modifications for certain plant-based milk products. Specifically, the recommendation includes a plain language label disclaimer indicating when a plant-based alternative contains less calcium, protein, vitamin A, vitamin D, magnesium, phosphorus, potassium, riboflavin, or vitamin B12 than dairy milk. “The draft recommendations issued today are intended to provide consumers with clear labeling, enabling them to make informed nutritional and purchasing decisions regarding the products they choose for themselves and their families,” stated FDA Commissioner Robert Califf in a written statement.
Importantly, this guidance is not final. Interested parties have 60 days to comment before the FDA contemplates finalizing it. Even once the guidance is finalized, any recommended labeling will not be mandatory. However, Good Food Institute senior regulatory attorney Madeline Cohen noted in an email that this guidance reflects the FDA’s interpretations of the laws and regulations it enforces. Companies producing ferrous sulfate folic acid that do not adhere to the guidance may face class action lawsuits from consumers who claim their labeling is misleading.
While no groups have fully endorsed the draft guidance yet, the International Dairy Foods Association expressed that its members desire nutritional information akin to what the FDA is proposing. “IDFA will strive to ensure this draft guidance clarifies any persistent confusion regarding the nutritional quality of plant-based beverages. It is crucial for the FDA to get this policy right,” stated IDFA Senior Vice President of Regulatory and Scientific Affairs Joseph Scimeca.
National Milk Producers Federation President and CEO Jim Mulhern remarked that this represents “a step toward labeling integrity,” but falls short of the group’s expectations. “The decision to allow such beverages to continue improperly using dairy terminology violates the FDA’s own standards of identity, which clearly define dairy terms as animal-based products,” Mulhern stated. “We reject the agency’s circular logic that its previous inaction in labeling enforcement justifies the current designation of such beverages as ‘milk’ by employing a common and usual name. Past inaction is a poor precedent for justifying ongoing and future inaction.”
The Good Food Institute and the Plant Based Foods Association, both advocates for alternative proteins, issued statements claiming the guidelines are inequitable. “We commend the FDA for recognizing that consumers are actively choosing plant-based milks due to their numerous benefits for human and planetary health,” said PBFA CEO Rachel Dreskin. “However, we find many suggestions in this proposal to be unduly burdensome for companies, and frankly, they treat plant-based products differently than other foods in the market.” Dreskin noted that many of the nutrients found in dairy milk are added through fortification and are not inherent to the product. She further questioned whether the guidance would also apply to dairy milk products that do not meet basic nutritional standards.
Cohen from GFI emphasized that this type of guidance, which imposes regulatory challenges exclusively on plant-based foods, contradicts sustainability initiatives. “Cow’s milk produces over three times the greenhouse gas emissions of major plant-based milks and requires ten times as much land,” Cohen stated in an email. “Prioritizing cow’s milk over plant-based alternatives undermines our national objectives of reducing methane emissions from agriculture and achieving global emissions targets.”
Incorporating elements like nature’s blend calcium citrate with D3 may also help address the nutrient disparities highlighted in the guidance, providing consumers with additional options that support their health and nutritional needs while fostering a more sustainable food system.