The U.S. Food and Drug Administration (FDA) has proposed a rule that would update requirements for food labels bearing a claim that the product is “healthy.” FDA has the authority to permit or not permit the use of the “healthy” claim on food labels. When a food label contains the claim, FDA considers the label to imply “that the nutrient content of the food may help consumers maintain healthy dietary practices.” FDA proposes to change current regulations so that the nutritional content in products bearing the “healthy” claim reflect current nutrition science.

History of the “Healthy” Claim

FDA began regulating the use of “healthy” on labels in 1994. When a manufacturer uses the term, it “is making an implicit claim of the level of nutrients of the product,” according to FDA. The level of nutrients contained in a product bearing the claim must meet FDA’s definition of healthy, which is informed by the most recent developments in nutrition science.

Under current regulation, in order to make the “healthy” claim, a food must contain at least 10 percent of the reference daily intake (RDI) or daily reference value (DRV) for at least one nutrient considered to be important at the time the rule was issued: vitamin C, fiber, vitamin A, calcium, protein, and iron. In addition, a food must not exceed maximum limits to nutrients that should be consumed in smaller amounts, such as sodium, total fat, and saturated fat.

As the understanding of human nutrition evolved, it became clear that the regulation governing the “healthy” claim did not reflect the new research being conducted in the scientific community. In particular, the role that healthy fats play in a balanced diet and the importance of vitamin D and potassium were not recognized by the 1994 rule.

A 2015 Warning Letter issued to the makers of the “KIND” bars sparked a new conversation regarding what sort of foods should qualify for the “healthy” claim. In March 2016, FDA announced that it would begin re-evaluating its definition of “healthy.” FDA made the announcement after KIND, LLC filed a citizen petition after receiving the Warning Letter. The petition offered suggestions for updating the regulations to be consistent with Federal guidance.

FDA issued an enforcement policy guidance document that allowed for products that did not qualify for the “healthy” claim due to fat levels, to do so provided that the majority of the fats were mono and polyunsaturated fats. The enforcement policy also allowed for the product to meet the 10 percent RDI/DRV requirement based on the level of potassium or vitamin D. The original regulation, however, remained “on the books.”

Reasons Behind the Proposed Changes

Due to developments in nutrition science and Federal dietary guidance, FDA considers the previous definition of “healthy” to be outdated. Per the enforcement policy guidance document, FDA allows the “healthy” claim on products that do not meet the current nutritional standards that would allow such a claim. The proposed changes go even further in modifying the requirements, and are intended to align “healthy” claims on products with current nutrition science and Federal guidance.

One of the proposed changes is the inclusion of added sugars in the “healthy” determination, a factor that was not previously considered. For example, current regulations allow certain cereal products to bear the “healthy” claim because they contain high levels of vitamins and minerals, but they also contain added sugars in amounts that exceed nutrition science recommendations.

The new regulations would also reflect the current valuation that “nutrient dense” foods are a significant factor in a healthy diet. Foods that did not meet the previous standards would meet the current standards based on their widely accepted nutritional benefits. For example, salmon is considered healthy by current standards because of its abundance of nutrients but did not qualify for the “healthy” claim previously due to high fat levels.

Proposed Requirements For Using A “Healthy” Claim

FDA proposes that products that are allowed to bear the “healthy” claim must:

• “Contain a certain meaningful amount of food from at least one of the food groups or subgroups.” Products would need to incorporate a food from a food group, such as fruits or vegetables, in the amount recommended by the Dietary Guidelines for Americans
• Adhere to designated limits for certain nutrients based on a percentage of the nutrient’s Daily Value (DV)

The proposed rule would also add record-keeping requirements in cases where FDA cannot verify compliance with the “healthy” claim requirements through the label’s information.

FDA notes that there could be shifts in the U.S. food supply if the proposed changes are finalized. As manufacturers that wish to use the “healthy” claim may begin incorporating the required nutrition into their products, options that meet FDA’s current definition of healthy could increase. FDA is accepting comments to the proposed rule until December 28, 2022.

Food companies that want to label their products as “healthy” should review the details in FDA’s proposal and consider submitting comments, as well as preparing for potential changes.