FDA began considering qualified health claims under the interim procedures on Sept. 1, 2003, and intends to continue to do so until regulations are promulgated by notice-and- comment rulemaking. In preparation for the rulemaking process, FDA published an advance notice of proposed rulemaking (ANPR) on Nov. 25, 2003 [75] requesting comments on three regulatory alternatives for qualified health claims:
• Codify the interim guidelines on procedure and evidence-based ranking through notice-and- comment rulemaking
• Apply the SSA standard to characterization of the scientific data rather than the substance-disease relationship and subject claims to notice- and-comment rulemaking, and
• Consider the claims outside NLEA and therefore subject only …show more content…
Other advantages of the first option noted by the Agency are FDA pre-approval of claims, opportunity for public comment, faster review times (reviews would be completed in 270 days) and greater flexibility for revisions to claims as scientific data evolves. FDA cited several drawbacks to the second option, including inflexibility, the burden of notice-and-comment rulemaking for each claim and vulnerability to First Amendment legal challenge due to lack of timeliness. Agency concerns about option three were identified as lack of FDA pre-approval, the burden of building enforcement cases (searching the literature, consulting experts and, in the case of possible implied claims, conducting consumer perception tests), and the absence of an opportunity for public comment. A procedure patterned after the generally recognized as safe (GRAS) notification process, would address the concerns articulated by FDA with respect to the three proposed options. A panel of independent experts, qualified by relevant training and experience, would evaluate the scientific evidence pertinent to a proposed qualified health claim and prepare a “generally recognized as efficacious” (GRAE) report that would be made publicly available. Companies wishing to use a qualified health claim would submit a notice to FDA containing the GRAE report and the proposed claim for review prior to use of the claim. Information concerning the training and experience of the qualified experts who prepared the GRAE report would also be made available to provide confidence in the scientific validity of the report. FDA would evaluate the submitted notice to determine whether there is sufficient basis for a GRAE determination for the proposed