12/20/2024 | Press release | Archived content
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:
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:
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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.
[1] "Healthy" claims include claims that use derivative terms such as "health," "healthful," "healthfully," "healthfulness," "healthier," "healthiest," "healthily," and "healthiness."
[2] These food groups include fruit, vegetables, grains, fat-free and low-fat dairy and protein foods.
[3] Eligible oil products include "100% oil," "oil-based spreads whose fats come solely from oil," and certain "oil-based dressing[s] containing at least 30% oil."