FDA proposes change to how “healthy” foods are defined

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Coinciding with the White House Conference on Hunger, Nutrition, and Health, the U.S. Food and Drug Administration (FDA) has published a proposed rule which would change the criteria for foods to carry the “healthy” claim. Currently, there are specific criteria based on minimum amounts of individual nutrients such as vitamin A, vitamin C, calcium, iron, protein, and dietary fiber, as well as limits on total fat, saturated fat, cholesterol, and sodium. These standards were set in 1994 and do not reflect our current understanding of nutritional science.

For example, the most recent Dietary Guidelines, 2020-2025, emphasizes a healthy dietary pattern that incorporates a range of nutrient dense foods such as fruits, vegetables, and whole grains. While these foods contain vitamins, minerals, and other health-promoting components with little added sugar, saturated fat, and sodium that work synergistically as part of a dietary pattern, because current guidelines place too much emphasis on individual nutrient levels, many of these nutrient-dense foods do not qualify to carry the claim of “healthy.”

“Nutrition is key to improving our nation’s health,” said HHS Secretary Xavier Becerra, in a press release. “Healthy food can lower our risk for chronic disease. But too many people may not know what constitutes healthy food. FDA’s move will help educate more Americans to improve health outcomes, tackle health disparities and save lives.”

Salmon for example, despite being rich in omega-3 fatty acids, cannot currently carry a “healthy” claim because of its natural fat content. At the same time, certain ready-to-eat cereal may be able to carry “healthy” claims based on the current definition but because of their levels of added sugar, may not qualify as “healthy” based on the most up-to-date nutrition science and dietary guidelines. This means, that while some foods may benefit from the proposed rule, others may no longer qualify to carry the claim based on their current formulation. FDA explains in a press release that cereal would need to contain ¾ ounces of whole grains and contain no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars to qualify for a “healthy” claim.

FDA believes this proposed rule could help reduce the incidence of diet-related chronic diseases, including cardiovascular disease and type 2 diabetes. ““Diet-related chronic diseases, such as cardiovascular disease and Type 2 diabetes, are the leading causes of death and disability in the U.S. and disproportionately impact racial and ethnic minority groups,” explained FDA Commissioner Robert M. Califf, MD, in a press release. “Today’s action is an important step toward accomplishing a number of nutrition-related priorities, which include empowering consumers with information to choose healthier diets and establishing healthy eating habits early. It can also result in a healthier food supply.”

With the emphasis on dietary patterns and food-group approach to classifying foods as “healthy,” the only mention of dietary supplements in the proposed rule is to differentiate them from food and to suggest that FDA does not want consumers to rely on supplements for proper nutrient intake. This, despite feedback from dietary supplement industry stakeholders.

“The recommendations [from the Dietary Guidelines, 2020-2025] include an emphasis on meeting nutritional needs ‘primarily from foods and beverages—specifically, nutrient-dense foods and beverages’, as opposed to dietary supplements,” states the proposed rule. “While FDA’s definition includes dietary supplements as foods, they may not always be included in what the nutrition science literature refers to as ‘foods’ This recommendation also reflects the view that good nutrition does not come from intake of individual nutrients (as dietary supplements often provide) but rather from foods with their mix of various nutrients working together in combination.”

“We were pleased that the White House invited NPA to participate in the nutrition conference but are confused why healthy nutritional supplements are not part of this new push by the FDA. Americans turned to supplementation like never before during the pandemic and saw the benefits for themselves. This opportunity should be expanded to all Americans who struggle with malnutrition and obesity,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, D.C.), in a press release. As such, said Fabricant, the association will be providing official comments on the proposed rule, and will be working with Congress and the Biden Administration to expand eligibility for supplements to more Americans through food support programs such as SNAP and WIC, as well as through employer-funded programs such as Health Savings Accounts.