Significant Scientific Agreement


Qualified health claims (QHCs) are supported by scientific evidence, but do not meet the stricter standard of “significant scientific contract” required for an approved health claim. To ensure that this information is not misleading, it must be accompanied by an exclusion of liability or other qualifying language, in order to accurately communicate to consumers the level of scientific evidence supporting the claim. Qualified health claims: THE FDA`s Consumer Health Information for Better Nutrition Initiative (2003) proposes the use of qualified health claims; QHCs) for foods or food supplements for which the scientific knowledge to support a substance/disease relationship is still being developed and has not evolved sufficiently to meet the SSA standards. These claims must include, as part of the claim, a qualifying language attesting that the evidence supporting the claim is limited. In July 2003, the FDA made available preliminary guidelines outlining the petition procedure and the evidence-based classification system for the evaluation of the scientific data indicating the claim. Since July 2003, the FDA has issued letters of implementation for several qualified health claims for foods and dietary supplements. Table 14.6 shows all QHCs allowed so far (August 2018). scientific knowledge from well-designed studies, conducted in accordance with generally recognized scientific principles and procedures, supports these claims; and since the FD&C Act does not allow the FDA to pass a regulation authorizing a specific health claim without a provision of the SSA, the process of authorizing qualified health claims involves issuing a letter of appreciation to be enforced rather than a regulation. Since the validity of the substance-disease relationship is not well established in a qualified health claim, qualified letters of appreciation for the application of health claims are intermediate and note that decisions to authorize claims will be re-evaluated by the FDA as soon as additional scientific evidence becomes available. A number of complaints filed by dietary supplement distributors in connection with the FDA`s implementation of Pearson v Shalala have contributed to the continued development of the FDA`s treatment of qualified health claim applications.

Under recent court rulings, the FDA is required to authorize most of the qualified health claims requested if they are supported by credible evidence. As a result, a policy seems to have evolved, where the length of the qualifying language required is inversely proportional to the degree of scientific support for a health claim.. . . .