07.01.03
In a recent letter to the FDA’s Task Force on Consumer Health Information for Better Nutrition, the Council For Responsible Nutrition (CRN), Washington, D.C., and the Consumer Healthcare Products Association (CHPA), Washington, D.C., urged the agency to reverse its decision regarding the requirement for dietary supplements with nutritive value (i.e. calcium) to carry disclaimers. According to the two organizations, FDA’s position requiring structure/function disclaimers for dietary supplements with nutritive value is directly at odds with the agency’s new policy initiative on Consumer Health Information for Better Nutrition. In light of this new initiative, both CRN and CHPA asked the agency to reconsider and reverse the decision to require structure/function disclaimers and notification for dietary supplements with nutritive value. As an example, the letter said, “Consider the label of a conventional food that makes an unqualified structure/function claim that calcium helps build strong bones, while the identical claim on the label of a dietary supplement bears a disclaimer that ‘This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.’ Confronted with food and supplement products side by side, a consumer could well infer that the calcium tablets’ claim is less certain or scientifically based than the claim for calcium in food. The likelihood of confusion is increased by the fact that FDA has approved a health claim for calcium and osteoporosis, a claim that appears on some dietary supplement products as well as foods without any requirement for a disclaimer.”
In a separate letter to FDA, CRN also expressed its concern regarding the “good news, bad news” format FDA has adopted for expressing qualified health claims. “These claims,” CRN said, “start out with an affirmative, unqualified statement and then essentially say that FDA does not believe it.” In CRN’s view, this construction seems unlikely to provide consumers with a good understanding of the nature of the support that exists for the statement or the reasons for FDA’s unfavorable view of the claim. As a result, CRN urged FDA to consider a more unified and informative statement as an alternative. FDA tentatively plans to approach qualified health claims by requiring that a petitioner begin by submitting a request for an unqualified health claim. Only if FDA concludes that an unqualified claim cannot be approved will the agency move on to considering a qualified claim. CRN said it joins other food industry associations in urging FDA to avoid unnecessary duplication of effort both for industry proponents and for the agency by permitting the direct submission of a petition for a qualified health claim.