i- FDA is in the process of updating its regulatory definition of the term “healthy” when it appears as an implied nutrient content claim on food labels. See FDA’s proposed rule published in September 2022. The current criteria for healthy claims (21 CFR 317.363) include limits for amounts of fat, saturated fat, cholesterol, and sodium, and also require foods to contain at least 10% of the daily value (DV) of one or more of vitamin A, vitamin C, calcium, protein, or fiber. The proposed criteria would establish a more complicated framework in which foods would be required to (1) contain at least one of the food groups or subgroups recommended by the 2020-2024 Dietary Guidelines for Americans (food group equivalents) and (2) would set limits for added sugars, saturated fats, and sodium. The required food group equivalents and the nutrient limitations would depend on product category.
- The 2024 Consolidated Appropriations Act, which was signed into law in March 2024, includes provisions dealing with the effective date of any final rule FDA issues in connection with this proposal. Specifically, the Appropriations Act states that (1) food manufacturers may continue to comply with FDA’s current requirements regarding the term “healthy” on food labels throughout the compliance date FDA provides in the final rule establishing new criteria, and (2) any food products manufactured and labeled as “healthy” during the compliance period FDA provides in that final rule shall not be directly or indirectly subject to any state-law requirements that are not identical to either the current or updated FDA requirements. See Section 745. We read this language, particularly the words “directly or indirectly,” as being intended to preempt any lawsuits that might target “healthy” claims under state consumer protection laws.
- We will continue to monitor and report on the updated healthy rule.
Consolidated Appropriations Act of 2024 Protects Food Companies Against Lawsuits Targeting Healthy Claims
Wednesday, April 17, 2024
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