The U.S. Food and Drug Administration (FDA) announced a final rule governing which products can use the claim “healthy.”

The new rule requires that foods, beverages, and dietary supplements alike which use the term “healthy” must contain a certain amount of food from at least one of the food groups or subgroups outlined by the Dietary Guidelines for Americans, including fruits, vegetables, protein foods, dairy, and grains. There are also limits on the amount of saturated fat, sodium, and added sugars.

According to the agency, the new rule will help consumers more easily identify foods that are the foundation of a healthy dietary pattern, and could potentially result in the development of healthier foods.

“It’s critical for the future of our country that food be a vehicle for wellness,” said Robert M. Califf, MD, FDA Commissioner. “Improving access to nutrition information is an important public health effort the FDA can undertake to help people build healthy eating patterns. It is vital that we focus on the key drivers to combat chronic disease, like healthy eating. Now, people will be able to look for the ‘healthy’ claim to help them find foundational, nutritious foods for themselves and their families.”

The agency stated that the updates to the “healthy” claim rule are designed to reduce the prevalence of diet-related diseases such as heart disease, diabetes, and cancer. “Data show that 77% of people exceed the current dietary recommendations for saturated fat; 79% of people have dietary patterns low in dairy, fruits, and vegetables; 63% of people exceed current dietary recommendations for added sugars; and 90% of people exceed the daily recommended limits for sodium,” the agency reported.

Jim Jones, FDA’s deputy commissioner for human foods, said that he hopes the new requirements can incentivize food manufacturers to reformulate their products. “There’s an opportunity here for industry and others to join us in making ‘healthy’ a ubiquitous, quick signal to help people more easily build nutritious diets.”

FDA is open to partnering with interested parties to support the use of the updated “healthy” claim rule. It has partnered with Instacart to make it easier for consumers to find products with the “healthy” claim through online grocery shopping filters and a virtual storefront. FDA is also working on a “healthy” symbol that manufacturers can use if their food meets the new rule’s criteria.

Criteria vary across different product types based on serving sizes and other factors.

Dietary Supplements Are Not Exempt

According to the new final rule, dietary supplements are not exempt from the criteria as they apply to foods. As a result, only a very marginal percentage of dietary supplement products are likely to be able to utilize the term “healthy” under the new rule.

 FDA reported that it received comments requesting that dietary supplements are exempt from the “healthy” claim requirements because they are intended to supplement the diet and are not represented as conventional foods, warranting unique parameters that would permit dietary supplements to bear the “healthy” claim, such as whether a product can maintain a healthy structure or function as outlined by structure-function claim guidelines.

However, “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. Consistent with this scientific understanding, the ‘healthy’ claim is intended to highlight those foods that are particularly useful in constructing healthy dietary patterns… Because this is the intent of the claim, we decline to exempt dietary supplements from the ‘healthy’ criteria. However, dietary supplements may bear nutrient content claims, including ‘healhty,’ if they meet the applicable criteria.”

The term “healthy,” can still be used in valid structure-function claims, but not as a standalone if supplements don’t meet the updated criteria.