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 FGEs and nutrient limits on sodium, added sugar, and saturated fat 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.
However, 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 sugar and cereal with a high amount of added sugar. 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 Feb. 25, 2028. That provides plenty of time for manufacturers to strategize and update labeling and possibly challenge the final rule under Loper Bright.
Claudia Lewis is co-chair of Venable LLP's FDA Group, where she counsels clients on matters involving FDA regulation, labeling and marketing of foods, over-the-counter (OTC) drugs, medical devices and other products.
