FDA Issues Long-Awaited “Healthy” Rule

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued the pre-publication version of its final rule establishing revised criteria for when foods can be labeled with the nutrient content claim “healthy.” This marks the culmination of a nearly ten year effort to update the “healthy” rule to reflect current nutrition science and federal nutrition guidelines. Covington’s client alert on FDA’s September 2022 proposed rule summarizes these efforts. The final rule largely adopts the “food group equivalent” approach to the “healthy” claim that FDA presented in its proposed rule, subject to certain key changes outlined below. The compliance date for the rule will be February 25, 2028, but manufacturers can begin to use a “healthy” claim in accordance with the new requirements as soon as the rule is in effect. FDA also indicated an intent to issue guidance before the compliance date to help ensure compliance with the new requirements.

1. Which “healthy” claims are subject to the rule?

The rule provides that “healthy” claims[1] are implied nutrient content claims—and thus subject to the rule’s criteria—if they “suggest that a food may help consumers maintain healthy dietary practices due to its nutrient content, where there is also implied or explicit information about the nutrition content of the food.” The latter part of this definition differs from FDA’s previous regulatory definition, which stated that “healthy” claims are nutrient content claims only when “made in connection with an explicit or implicit claim or statement about a nutrient (e.g., healthy, contains 3 grams of fat).”

While FDA describes this as a “minor revision” that aims to “bring [the ‘healthy’ definition] in line with the updated criteria for the ‘healthy’ claim,” it is possible that this change could subject a broader universe of claims to the “healthy” rule. For example, FDA notes that, under this revised definition, information presented in voluntary front-of-pack icons such as MyPlate and Facts Up Front could “provide the requisite nutritional context to establish an implied nutrient content claim” when used on a product label with a “healthy” claim. Stakeholders should therefore closely consider whether this change could affect the regulatory status of any “healthy” claims they make on their labels.

2. When can foods make “healthy” claims under the rule?

The final rule adopts the “food group equivalent” framework that FDA outlined in its proposed rule. Under this framework, foods making a “healthy” nutrient content claim generally must(1) contain a certain amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines for Americans[2] (referred to as “food group equivalents” or “FGEs”) and (2) fall below specific nutrient limits for added sugars, sodium, and saturated fat. These FGE requirements and nutrient limits vary for different types of foods (e.g., individual foods vs. mixed food products). Specifically, the rule provides that a food can make a “healthy” nutrient content claim only if it meets one of the following six criteria: 

1. The food is an individual food or mixed food product comprised of one or more of the following foods, with no ingredients added except for water: vegetables; fruits; whole grains; fat-free or low-fat dairy; or lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds.
2. The food is an individual food that contains at least one FGE and meets the nutrient limits for added sugars, sodium, and saturated fat applicable to the relevant food category, either per RACC (for foods with a RACC greater than 50 g or 3 tablespoons) or per 50 g (for foods with a RACC up to 50 g or 3 tablespoons). Some oil products are eligible to make “healthy” claims under this provision if they meet certain nutrient thresholds for added sugars, sodium, and saturated fat, despite the fact that there are no FGEs applicable to oil products.[3]
3. The food is a mixed product that contains at least one FGE, with no less than 1/4 an FGE from at least two food groups, and meets certain nutrient limits for added sugars, sodium, and saturated fat, per RACC.
4. The food is a main dish product that contains at least two FGEs, with no less than 1/2 an FGE from at least two food groups, and meets certain nutrient limits for added sugars, sodium, and saturated fat, per labeled serving.
5. The food is a meal product that contains at least three FGEs, with no less than 1/2 an FGE from at least three food groups, and meets certain nutrient limits for added sugars, sodium, and saturated fat, per labeled serving.
6. The food is a water, tea, or coffee product with less than 5 calories per RACC and per labeled serving.

The final rule also requires that manufacturers of foods that make “healthy” nutrient content claims maintain records demonstrating that the foods meet the applicable FGE requirements, unless the food’s mandatory labeling information (e.g., the food’s ingredient list) makes this sufficiently clear. Manufacturers must maintain these records for at least two years after the food is introduced or delivered for introduction into interstate commerce.

3. What are the key differences between the final rule and the proposed rule?

FDA revised various components of the proposed rule in response to stakeholder feedback. Some key changes include:

• FDA implemented added flexibility for individual foods that are consumed in small quantities by providing that foods with a RACC of 50 g or less or 3 tablespoons or less should be evaluated against the rule’s criteria on a per 50 g basis, rather than a per RACC basis.
• FDA expanded the proposed rule’s exemption for raw, whole fruits and vegetables such that any individual food or mixed product that is comprised of one or more of the foods encouraged by the Dietary Guidelines, with no other added ingredients except for water, automatically qualifies for the “healthy” claim.
• FDA has allowed for added flexibility in the proportions of FGEs required for combination foods. For example, the final rule provides that mixed foods must contain at least one FGE, with 1/4 an FGE from at least two food groups. By contrast, the proposed rule would have required 1/2 FGEs from each of at least two food groups.
• FDA streamlined the nutrient limits for mixed products, main dishes, and meal products so that each category has only one limit for sodium, added sugars, and saturated fat (rather than separate limits for food groups within each category).
• FDA increased the sodium nutrient limit for mixed food products from ≤ 10% DV to ≤ 15% DV per RACC.
• FDA increased the added sugars nutrient limit for whole grain products from ≤ 5% DV to ≤ 10% DV for the grains group and increased the added sugars nutrient limit for individual fruits, vegetables, and protein foods from 0% DV to ≤ 2% DV.
• FDA expanded the proposed rule’s exemption for plain and plain carbonated water to include all water, tea, and coffee with less than 5 calories per RACC and per labeled serving. This means the exemption now includes carbonated or noncarbonated water, coffee, and tea, containing non-caloric ingredients such as flavors, no- or low-calorie sweeteners, vitamins, and minerals.

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FDA also confirmed that, in addition to finalizing the “healthy” rule, the agency is continuing its efforts to develop a “healthy” symbol that manufacturers can use to indicate that their foods meet the agency’s new “healthy” criteria. FDA is advancing these and other initiatives—including those regarding front-of-pack nutrition labeling and sodium reduction—as part of the Biden Administration’s White House National Strategy on Hunger, Nutrition, and Health. The front-of-pack proposed rule is currently under review at the Office of Information and Regulatory Affairs (OIRA) and could also be issued before the presidential inauguration next month.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.