Improvements in diet and nutrition offer one of the greatest opportunities to profoundly impact human health. Innovation in the food sector is occurring rapidly to address this opportunity and meet the needs and values of modern consumers. The FDA is committed to advancing policies that enable consumers to safely benefit from innovations in how foods are produced.
I outlined these goals, and some of the ways we seek to achieve them, in our Nutrition Innovation Strategy. Keeping pace with the rapid innovation that has the potential to improve the choice consumers have, and the nutritional attributes of the foods they consume, is core to this commitment. So is empowering consumers with the information they need to make good choices about the foods they eat through greater transparency about food attributes.
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.
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.
At the same time, the FDA is taking actions to facilitate food innovations that can give consumers more choices, enable better nutrition, and improve labeling to reflect the healthy attributes of food. Diet is a powerful tool for reducing chronic disease and its impact on the healthcare system.
Among other new steps we’re taking, modernizing the outdated framework for food standards will allow industry flexibility for innovation to produce more healthful foods while maintaining the basic nature, essential characteristics and nutritional integrity of key food 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.
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.
While dairy has received a lot of attention, there are many other standards of identity that need to be revisited and potentially modernized. After all, there are nearly 300 of these standards of identity on our books, some of which were created in my grandparents’ generation.
We intend to apply this science-based, public-health driven approach to the work we’re doing in relation to dairy alternatives. And we look forward to keeping you updated throughout this process.