FDA ANNOUNCES REVISION OF “HEALTHY” CLAIM
FINAL RULE
Washington D.C., (Dec 19, 2024) - Today the FDA announced the long awaited “Healthy” Final rule: Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”. This rule finalizes a 2022 proposed rule and updates a prior definition of the voluntary claim that is 30 years old. The final rule is being released to align the “Healthy” claim criteria with the updated Nutrition Facts label and the current Dietary Guidelines for Americans. In a statement, the FDA said that this rule is part of the agency's work "to help reduce the burden of diet-related chronic diseases."
The new definition updates 21 CFR 101.65(d) and is intended to better account for how nutrients in various food groups contribute to healthy dietary patterns. Similar to the proposed rule, the final framework defines recommended nutrient-dense food groups as well as thresholds for specific nutrients to limit. In addition, despite early indication that an authorized symbol may be included with the updated claim, no graphical representations of a “Healthy” logo were proposed. FDA does note that the agency is continuing to explore this possibility.
Summary:
In the final rule, a food is eligible to be labeled as “Healthy” if:
- The product contains meaningful amounts of food from a food group or subgroup recommended by the Dietary Guidelines for American (e.g. vegetables, fruits, dairy, grains, protein foods, as well as oils), and
- The product is within specific thresholds for saturated fat, sodium, and/or added sugar.
For example, a vegetable product is required to contain at least ½ cup equivalent vegetable and no more than 2% DV added sugar where a grain product is required to contain at least ¾ oz equivalent whole grain and no more than 10% DV added sugar. Both products are limited to 10% DV sodium and 5% DV saturated fat.
Record keeping will also be required if the relevant food group is not readily apparent. (Similar requirements exist in the recent update to the Nutrition Facts label and the Bioengineered Food disclosure.) In this case, specific records will generally be related to the volume of the food group equivalents present.
Manufacturers will have three years to implement these changes, after which any product introduced into the market will need to comply with the updated definition. Products may be labeled “Healthy” under the new definition, however, as soon as the Code of Federal Regulations is amended, scheduled for 60 days past this final rule’s publication.
Next Steps:
Prime Label recommends that food companies begin to familiarize themselves with the new rule and re-evaluate any “Healthy” claims made on their current products (in addition to evaluating if a new “Healthy” claim can be applied to other products).
If you are interested in learning more about these changes to “Healthy” (or regulatory considerations for other nutrient content claims), consider joining PLC’s upcoming live Webinar on Nutrition Labeling next month. The January 29 session on Nutrient Content Claims will include our expert analysis of the new rule. For more learning opportunities, we hope to see you in Washington DC at the Annual Food Label Conference June 1 - 4. Registration is available here.
PLC Regulatory Consultants are available today to help determine whether your labels are eligible for the new “Healthy” claim or if any legacy products need revision. For more information, go to our Services Order form or contact us at labels@primelabel.com or (202) 546-3333.
In addition, EZ Form Label Compliance Software’s Nutrient Navigator Claims Calculator will be updated for the new criteria in the first quarter of 2025.
We will continue to monitor developments on the “Healthy” symbol with our contacts at the FDA for late-breaking news and notify our Label Alert subscribers as soon as new information is available.
For more information, visit us on the web at www.primelabel.com.
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