In February 2022, the U.S. Food and Drug Administration (FDA) published their  “Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers.” The draft guidance is intended to reflect FDA’s current thinking, recommendations, and interpretations on specific topics related to the regulation of plant-based milks labeling.

The February 2022 draft guidance accurately recognized the will of the consumer in selecting plant-based milks instead of animal-based options, the recommendation to include voluntary nutrient statements is unprecedented, unwarranted, and a solution in search of a problem. However, it also implied that the inherent nutritional content of plant-based milk products are somehow inferior to that of dairy milk products, despite the fact many of the nutrients boasted by animal-based milk are the result of fortification. PBFA maintains that this suggestion is not only discriminatory towards the plant-based sector—no other products, including different brands of animal-based milk, are targeted by this guidance—but it also threatens to jeopardize growth of the innovative plant-based foods industry. After releasing their guidance, the FDA held an open comment period to garner feedback from the public.

In order to ensure a thorough review of the research and background information the FDA credited with informing their guidance, the PBFA policy team worked to secure an extension to the comment period, filing a Freedom of Information Act Request to fully vet and access the vital materials used by FDA. After reviewing the consumer research FDA used to form their recommendation, PBFA submitted a comment on July 31, 2023 raising our concerns and objections to the proposed draft guidance with four critical points emerge that warrant closer examination.

  1. Firstly, the proposed regulations for plant-based milks appear unprecedented and unique. The FDA recommends that if these products use the term “milk,” they must prominently display “Nutrient Disclaimers” if they do not meet specific nutrient requirements found in cow’s milk. Additionally, the guidance calls for detailed ingredient information. These obligations apply solely to plant-based milks, raising questions about fair treatment among food products.
  2. PBFA challenges the validity of the FDA’s concerns. The agency cites consumer confusion and potential public health risks, but PBFA argues that the evidence is lacking and biased. Reports funded by the dairy industry are alleged to contribute to the FDA’s findings, which expert, Dr. Joel Steckel, believes are flawed due to “confirmation bias.” Independent studies show no consumer confusion about the nutritional differences between plant-based milks and cow’s milk.
  3. Furthermore, PBFA highlights the environmental impact of plant-based diets. Encouraging a shift towards such diets is essential for mitigating climate change, as they have the potential to substantially reduce greenhouse gas emissions. The United Nations Intergovernmental Panel on Climate Change recommends transitioning to plant-based diets to combat the climate crisis effectively. As we stated in comments previously submitted to the FDA, encouraging an American transition to a plant-based diet supplied by American farmers is one of the leading ways we can cut greenhouse gases and mitigate climate change. FDA’s draft guidance could create a roadblock to marketplace expansion of plant-based foods while the agency should be supporting and promoting plant-based diets in accordance with our climate goals.
  4. Lastly, PBFA challenges the necessity of the proposed Nutrient Disclaimers, arguing that existing FDA regulations already require comprehensive nutrient labeling on the Nutrition Facts Panel. The additional disclaimers are seen as redundant and unwarranted, lacking precedent for other food products. The use of school nutrition standards as the basis for these requirements is also criticized, as these standards were designed for a unique environment (school meals) and may not apply to the broader consumer marketplace.

In conclusion, the FDA’s Draft Guidance on plant-based milks has raised concerns among industry stakeholders. PBFA argues that the proposed Nutrient Disclaimers and Naming Obligations are unwarranted, unsupported by evidence, and could hinder the growth of the plant-based foods industry. Additionally, the guidance could mislead consumers and infringe upon First Amendment rights. As public feedback and discussion continue, PBFA is hopeful FDA will carefully consider the perspectives shared to determine the final regulations. The outcome will undoubtedly impact the future labeling and marketing of plant-based milks and may set a precedent for the treatment of other plant-based food products in the market.

To read PBFA’s full comment, click here.