In a Federal Register notice published last November, FDA issued an advance notice of proposed rulemaking (ANPRM) to request comments on alternatives for regulating qualified health claims in the labeling of conventional human foods and dietary supplements. In its notice, FDA pointed out three alternatives that it is considering for regulating qualified health claims and requested comments on these alternatives or options. The American Herbal Products Association (AHPA) believes that, of the three alternatives identified in the ANPRM, a varied approach to Option 1—an evidence-based ranking system that would require a premarket petition of qualified health claims—would provide the greatest benefit to consumers. This belief, according to AHPA, is grounded in the conviction that this regulatory model would provide the proper balance between a marketer’s obligations to ensure that any qualified health claim is truthful and not misleading and the role that FDA must play in administering rules that implement the court decisions that serve as the background for this rulemaking. AHPA also recommended that Option 1 be modified so that regulatory outcomes affirmatively state that the agency “approves” or “is not opposed to” qualified health claims that are supported by credible evidence, and that flexibility be provided with regard to specific qualifying language. AHPA was also in agreement with the Task Force on Consumer Health Information for Better Nutrition, which suggested removing the requirement in current regulations for the word “may” from unqualified health claims.

The Council for Responsible Nutrition (CRN), along with the Consumer Healthcare Products Association (CHPA), Washington, D.C., also put forth comments to the ANPRM. The two organizations found favor with a modified evidence-based ranking system for qualified health claims. In addition, CRN and CHPA also responded to FDA’s request for how to encourage companies to develop data needed for an unqualified health claim by suggesting that the agency consider a period of exclusivity (ranging from 12 to 24 months) for the claim. Furthermore, CHPA suggested FDA review petitions for new qualified health claims within 270 days, after which qualified claims could be used unless FDA concludes that the proposed claim is not supported by the data. It also suggested that FDA establish a review time not to exceed 120 days for qualified health claims endorsed by non-government review panels and that FDA review modifications based on new scientific data to the qualifying language of existing claims within 90 days.