The Food and Drug Administration (FDA) announced that it has issued a final rule to update the “healthy” claim that marketers can use on food packages and labels.  The rule revises the requirements for the implied nutrient content claim “healthy,” which was previously set in 1994, in order to be consistent with current nutrition science and federal dietary guidance.

Born out of its concern that diet-related chronic diseases in the U.S. are a leading cause of death and disability, and because they “are experienced disproportionately by certain racial and ethnic minority groups and those with lower socioeconomic status,” the FDA’s action is intended to empower consumers to more easily make healthful food choices, to promote health equity, and to help foster a healthier food supply, assuming that “some manufacturers voluntarily reformulate food products to meet the updated criteria.”

Now, to qualify as “healthy,” a food product must: 

• contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and 
• adhere to specified limits for added sugars, saturated fat and sodium.

The criteria for the amount of food required from a particular food group (called “food group equivalents”) and the specific limits for the three individual nutrients will vary based on the type of food product and serving size. 

Significantly, the final rule’s definition of “healthy” includes food groups that provide a number of different nutrients, rather than focusing on one individual nutrient in isolation. As noted in the commentary of the rule, “[t]he use of food groups better accounts for how all these nutrients contribute, and may work synergistically, to create a healthy dietary pattern and improve health outcomes.” 

Under the updated definition, foods such as avocados, nuts and seeds, higher fat fish (like salmon) and olive oil will now qualify to use the “healthy” claim—including more budget-friendly varieties, like fruits, vegetables and fish that are frozen or canned. On the other hand, foods like fortified white bread and highly sweetened yogurts and cereals will no longer qualify. 

Separately, the FDA is exploring the development of a standardized “healthy” symbol that could be used on food labeling to further support the FDA’s goal of helping consumers identify foods that can serve as the foundation of a nutritious diet.

The FDA, Federal Trade Commission (FTC) and the United States Department of Agriculture share jurisdiction over claims made by manufacturers of food products.  Under a Memorandum of Understanding, the FDA has taken primary responsibility for regulating food labeling, while the FTC has assumed primary responsibility for regulating food advertising, including health claims.  The FTC has sought to harmonize its enforcement efforts with the FDA’s labeling regulations and has traditionally accorded great weight to the FDA’s scientific determinations in matters of nutrition and health.  The principal elements of the FTC’s approach to health claims in food advertising are set forth in its Enforcement Policy Statement on Food Advertising.

The FDA’s final rule will take effect 60 days after its publication in the Federal Register, with such effective date currently anticipated to be in late February.