FDA Updates ‘Healthy’ Claim for Foods — but Use Is Voluntary

The US Food and Drug Administration (FDA) issued a final rule on December 19 that updates the “healthy” nutrient claim on food labels, although compliance by manufacturers is voluntary.

To bear the “healthy” claim, a food product needs to contain a certain amount of food (food group equivalent) from at least one of the food groups or subgroups (such as fruits, vegetables, fat-free and low-fat dairy etc.) recommended by the Dietary Guidelines for Americans and also adhere to specified limits for the following nutrients: saturated fat, sodium, and added sugars. 

For example, to include the “healthy” claim on the package, a cereal needs to contain a certain amount of whole grains and adhere to limits for saturated fat, sodium, and added sugars (Figure).

Nuts and seeds, higher-fat fish such as salmon, certain oils, and water didn’t qualify for the “healthy” claim before but are foundational to a healthy eating pattern and recommended by the Dietary Guidelines for Americans, according to the FDA, meaning they now qualify as “healthy.” Many foods that fit into a range of budgets, such as some peanut butters and canned fruits and vegetables, also qualify. 

Manufacturers who choose to use the “healthy” claim have 3 years to conform but can use the new criteria sooner. Meanwhile the FDA is exploring the possibility of developing a symbol that a manufacturer could use on the label to show that its product meets the criteria. The agency is also working on an initiative that would add a front-of-package nutrition labeling scheme for packaged foods.

Commenting on the new rule, the American Heart Association’s chief executive officer, Nancy Brown, said in a statement, “The new definition moves from an exclusive focus on individual nutrients to a system that also emphasizes the type of food and how it contributes to a healthy dietary pattern.” 

However, she added, “Although the updated ‘healthy’ claim is an important update to food labeling, it is voluntary and may only appear on a limited number of food and beverage packages. That’s why the FDA’s work on front-of-pack nutrition labeling is so important. A mandatory front-of-pack labeling system based on the best available science and consumer research would give consumers valuable information about the nutritional value of all foods and beverages and help them quickly and easily identify healthier options.”

Scott Faber of the nonprofit Environmental Working Group also commented, noting, “The FDA’s new rule still falls short, particularly in allowing food products with harmful food chemicals and ultra-processed ingredients to be labeled as ‘healthy.’”

But Marion Nestle, a nutrition expert and emeritus professor at New York University, described the new rules as “better than I thought it would be” in USA Today.

She said the rules “include ‘real,’ unprocessed foods and exclude most ultra-processed foods, such as sugar-sweetened foods like most children’s cereals.”

The unpublished version of the rule is available now for viewing. The final document is scheduled to be published in Federal Register on December 27, 2024, and on GovInfo.

Marilynn Larkin, MA, is an award-winning medical writer and editor whose work has appeared in numerous publications, including Medscape Medical News and its sister publication MDedge, The Lancet (where she was a contributing editor), and Reuters Health.