FDA final "healthy" rule: key herbal takeaways

• By: AHPA
• On: 01/02/2025 16:05:08
• In: AHPA News

January 2, 2025

In late December, the US Food and Drug Administration (FDA) released its final rule on the labeling of foods with the word “healthy” as an implied nutrient content claim. Several elements of the final rule responded to comments from the American Herbal Products Association (AHPA), as detailed below.

• FDA declined to exempt dietary supplements from the nutrient content and food group equivalency requirements established for conventional foods.

• In response to comments from AHPA and others, the agency modified the rule such that coffees and teas (of Camellia sinensis specifically) may bear “healthy” nutrient content claims, so long as they do not contain added caffeine and contain fewer than 5 calories per labeled serving and reference amount customarily consumed.

• In response to comments from AHPA, the agency clarified that the term “healthy” may continue to be used in valid structure function claims.

• Similarly, products lawfully bearing “healthy” claims in compliance with the prior rule will not be in violation so long as they were labeled in advance of the compliance date.

• FDA stated that herbs or spices may qualify as vegetables for the purpose of calculating food group equivalence for the use of “healthy” claims, but declined to permit them to automatically qualify as “healthy.”

• In response to comments from AHPA and others, the agency agreed that dried or other powdered fruits and vegetables can be considered in food group equivalency calculations provided that the powders are essentially the dried and ground forms of the original whole food.

The compliance date for the final rule is February 25, 2028. Additional summarizing information on the rule is available at this site.  FDA communicated in the final rule that it intends to, prior to compliance date, provide further guidance to help manufacturers in the calculation of food group equivalence values. AHPA will continue to inform its members and the herbal products community of additional resources on this rule as they become available.