“Food labels – including the name of food – inform consumers about what they’re buying, and standards of identity are used to ensure that foods have the characteristics expected by consumers,” wrote FDA Commissioner Scott Gottlieb, M.D., in a July 26 statement on the process FDA is undertaking for reviewing and modernizing its standards of identity for dairy products. “The information provided through food labeling must be truthful and not misleading. The consumer choices made based on this information can have important impacts on health.”
Following is Gottlieb’s discussion on review of plant-based foods positioned as substitutes for standardized dairy products:
“One area that needs greater clarity – and which has been the subject of much discussion of late – is the wide variety of plant-based foods that are being positioned in the marketplace as substitutes for standardized dairy products. Many of these plant-based foods use traditional dairy terms (e.g., milk, yogurt, cheese) in the name of the product. For instance, we’ve seen a proliferation of products made from soy, almond or rice calling themselves milk. However, these alternative products are not the food that has been standardized under the name “milk” and which has been known to the American public as “milk” long before the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was established. In addition, some of these products can vary widely in their nutritional content – for instance in relation to inherent protein or in added vitamin content – when compared to traditional milk.
“We intend to look at these differences in relation to potential public health consequences. There are reports that indicate this issue needs examination. For example, case reports show that feeding rice-based beverages to young children resulted in a disease called kwashiorkor, a form of severe protein malnutrition. There has also been a case report of a toddler being diagnosed with rickets, a disease caused by vitamin D deficiency, after parents used a soy-based alternative to cow’s milk. Because these dairy alternative products are often popularly referred to as ‘‘milk,’’ we intend to look at whether parents may erroneously assume that plant-based beverages’ nutritional contents are similar to those of cow’s milk, despite the fact that some of these products contain only a fraction of the protein or other nutrients found in cow’s milk.
“We hope that the examination of this issue will demonstrate whether future cases of kwashiorkor or rickets may be prevented by changes to the labeling of these products, as well as by the education of physicians and parents about the nutritional content of these beverages. Such public health concerns are one of the reasons why we’re prioritizing this effort to take a closer look at the standards of identity for dairy products as part of our overall process for modernizing our standards of identity and advancing the information consumers have to inform their diets.
“We will not be doing this in a vacuum. We’re going to have an active public process for reviewing our standard and how consumers understand the use of terms like milk on both animal-derived and plant-based products. We want to see if the nutritional characteristics and other differences between these products are well-understood by consumers when making dietary choices for themselves and their families. We must better understand if consumers are being misled as a result of the way the term milk is being applied and making less informed choices as a result.
“We also are actively looking at how we have been enforcing the FD&C Act with respect to food names and our own standard of identity for milk and what it means when milk is qualified with words like almond or soy. We recognize that, as a regulatory agency, it’s not appropriate to unilaterally change our regulatory approach if we have a history of non-enforcement. We also need to closely consider the potential First Amendment issues related to the different uses of these terms.
“This week we will start the process of modernizing our standards of identity broadly by gathering stakeholder feedback at our Nutrition Innovation Strategy Public Meeting. We encourage all interested stakeholders to continue to submit comments to the docket for this meeting. We’ll be reviewing the information gathered and posting an additional request for information, likely in the late summer or early fall, with a specific set of questions pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives, with a focus on nutritional impact. The feedback we receive will help inform a revisiting of our policy for these terms. Over the next year, we will be looking at next steps which will likely include issuing guidance for industry and a new compliance policy outlining our enforcement approach.
“In the meantime, we’ll continue to take actions when we become aware of products with misleading labels that have a high likelihood of consumer misunderstanding as to the basic nature of the product, especially when nutrition and therefore public health may be at risk.”