What does "Healthy" mean On Human Food Products

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FDA To Publish Final Rule Defining “Healthy” Claims

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Friday, December 20, 2024

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On December 19, 2024, FDA released the pre-publication of the final rule updating the definition for the implied nutrient content claim, “healthy.” The final rule will be published in the Federal Register on December 27. The final rule revises the requirements for making a healthy claim on human food products. FDA’s labeling rule is part of a broader initiative aimed at reducing diet-related disease and promoting health equity as part of the White House National Strategy on Hunger, Nutrition, and Health.
This rule finalizes the 2022 proposed rule and updates the definition of “healthy” which was last defined at 21 CFR 101.65 thirty years ago. The previous definition was based on outdated nutrition science and did not account for the latest dietary guidelines.
Under the final rule, for a food product to bear a “healthy” (or any derivative e.g., “healthful”) claim the food product must:
- (1) Contain a certain amount of food from one of the Food Group Equivalents (FGE) established by the Dietary Guidelines, 2020-2025 (vegetables, fruits, dairy, grains, protein foods, and oils); and
- (2) Adhere to specified limits related to saturated fat, sodium, and added sugar.
For example, for a vegetable product to make a “healthy” claim it must:
- Contain at least ½ cup equivalent vegetable and
- Contain no greater than 2% of the Daily Value (DV) of added sugar, no more than 10% of the DV of sodium, and no more than 5% of the DV of saturated fat.
In addition to the six categories of FGE’s established above, there are distinct requirements for mixed products, main dishes, and meal products:
- Mixed Products: Must contain at least one total Food Group Equivalent (FGE) with no less than 1/4 FGE from at least two food groups and added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
- Main Dish: Must contain at least one total FGE with no less than 1/4 FGE from at least two food groups and the added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
- Meal Products: Must contain at least one total FGE with no less than 1/4 FGE from at least two food groups and added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
The new rule makes modifications for certain foods that contain healthy fats such as fish and nuts that were before unable to qualify for the healthy claim. For example, the final rule makes a note for seafood, nuts, seeds, and soy products that the DV limit established by the rule excludes saturated fat inherent in the food product. Further, the updated rule introduces specific limits on added sugars. Now, foods high in added sugars, which do not align with current nutrition science and dietary guidelines, can no longer be labeled as “healthy.”
These changes are designed to help consumers make better-informed choices and promote healthier eating patterns. FDA is also developing a “healthy” symbol that manufacturers can use on food packaging to help consumers quickly identify products that meet the “healthy” criteria.
The rule goes into effect 60 days after publication in the Federal Register, which is expected to be published on December 27, 2024, and the compliance date is February 25, 2028. Keller and Heckman will continue to monitor developments related to the final rule’s implementation and enforcement.