Earlier this week, as part of the White House Conference on Hunger, Nutrition, and Health, President Biden announced a goal of ending hunger and increasing healthy eating and physical activity by 2030 so fewer Americans experience diet-related diseases.  The strategy identifies actions to be taken across five guiding pillars: first, improving food access and affordability, second, integrating nutrition and health, third, empowering all consumers to make and have access to healthy choices, fourth, supporting physical activity for all, and finally, enhancing nutrition and food security research.  In order to achieve the third pillar, President Biden proposes, among other things, to develop a front-of-packaging labeling scheme for food packages, facilitate sodium reduction in the food supply by issuing longer-term, voluntary sodium targets for industry, and finally to propose an update to the nutrition criteria for a “healthy” claim on food packages. On the heels of this announcement, FDA released a proposed rule that would bring the requirements to use the word “healthy” in a claim in-line with modern dietary guidance.

What Is Changing?

The proposed rule attempts to harmonize the definition of “healthy” with the current recommendations published in the Dietary Guidelines for Americans 2020-2025.  Accordingly, the proposed “healthy” definition uses a food group-based approach in addition to nutrients to limit (based on the understanding that each food group contributes an array of important nutrients to the diet), which has changed since 1994, when the current definition of “healthy” was promulgated.  The proposed rule would also require a food to contain a certain amount from at least one of the food groups or subgroups (vegetables, fruits, grains, dairy, and protein foods) recommended by the Dietary Guidelines in order to use the “Healthy” claim, e.g., there must be at least ½ cup of fruits or vegetables, 3/4 cup of dairy, a range of 1-1 and 1/2 ounces of protein depending on the type, or no less than 3/4 ounce whole grain. Additionally, the new rule discards certain nutrient requirement provisions as no longer relevant while prescribing limits on three specific nutrients – sodium, saturated fat, and added sugar.  Required amounts and limits are all adjusted for each specific food group, as well as the type of item (a mixed product, a main dish, a meal) in question.  Finally, the proposed rule creates a group of foods, including raw and whole fruits and vegetables, and water, that will be automatically considered “healthy” and can use the claim without being subject to requirements for food group equivalent amounts or the nutrients to limit.
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