On December 27, 2024, the Department of Health and Human Services, Food and Drug Administration, redefined the use of "Healthy as a nutrient content claim” amending Food Labeling 21 CFR Part 101.

The regulation highlights the following:

• Establishment of food group equivalents (FGEs) to identify qualifying amounts of foods from each group, such as vegetables, grains, and fruits, etc, based on their nutritional content;
• Food products must meet FGE requirements and limits for added sugars, saturated fat, and sodium according to the Daily Value (DV);
• Fruits, vegetables, whole grains, seafood, nuts and seeds, etc as indicated in the guideline, without added ingredients (except water), inevitably qualify for the “healthy” claim;
• Water, tea, and coffee with less than 5 calories per serving automatically qualifies as ‘‘healthy’’;
• Emphasizes the importance of recordkeeping by manufacturers to demonstrate compliance with the updated "healthy" criteria.

This rule is effective February 25, 2025 and the compliance date of this final rule is February 25, 2028.

As the FDA continues to refine its regulations, businesses in the food and beverage industry must adapt swiftly to ensure compliance and maintain consumer trust. Trace One provides the tools and expertise needed to stay ahead of these changes, simplifying the process of meeting evolving standards. Discover how our solution can help your business navigate regulatory complexities with confidence. Learn more about Trace One Regulatory Compliance here.