FDA Issues Final Rule Updating the Criteria for Use of the "Healthy" Nutrient Content Claim

2 min

On December 19, 2024, the Food and Drug Administration (FDA) announced a final rule updating the definition of the term "healthy" as used in food labeling. Under the rule, manufacturers may use the term "healthy" and similar words (e.g., "healthful," "healthiest," or "healthiness") only if a food product meets two criteria. First, the product must contain a certain amount of food from specific food groups or subgroups (vegetables, fruits, low-fat dairy, grains, protein foods, and oils). Second, the product must meet new limits on sodium, added sugars, or saturated fat.

To determine whether a product contains the right amount of food, the rule creates what FDA calls food group equivalents (FGEs). These are a reference measure for how much of a certain food group must be present in a food product for its manufacturer to be permitted to use a "healthy" claim. The rule sets differing FGE and sodium, added sugar, and saturated fat nutrient limits for individual food products, mixed products (contain more than one food group), and main dish and meal products.

Notably, under the final rule, foods such as vegetables, fruits, seafood, eggs, and beans will now "automatically qualify" for the term "healthy," provided they have no added ingredients besides water. Water, tea, and certain coffees will also automatically qualify for the "healthy" claim. Further, several high-fat foods, such as salmon and avocados, are now eligible for the "healthy" claim. Some foods that once were able to use the "healthy" claim now no longer qualify under the new final rule, such as fortified white bread, yogurt with a high amount of added sugars, and cereal with a high amount of added sugars. To be generous, this calls into question whether most dietary supplements will be able to meet the criteria.

Further, FDA is exploring the development of a symbol companies could use on a food product label to indicate it is "healthy" under the new definition in the final rule. Full compliance with the new standard is required by February 25, 2028. That provides plenty of time for manufacturers to strategize and update labeling and possibly challenge the final rule under Loper Bright.

What's Next?

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If you have questions about the content of this article or the implications of the final rule for your company, please contact the authors of this article.