DIETARY SUPPLEMENT HEALTH CLAIM EXPEDITED REVIEW MECHANISM SUGGESTED BY CRN

DIETARY SUPPLEMENT HEALTH CLAIM EXPEDITED REVIEW MECHANISM SUGGESTED BY CRN in Aug. 17 comments on FDA's June 18 proposed rule implementing the health claim provisions of the Nutrition Labeling & Education Act for dietary supplements. Under the system envisioned by the Council for Responsible Nutrition, FDA would be "required to publish a rule either authorizing or disapproving" a health claim petition within 60 days of receiving it if the agency "determines during its initial review of the petition that it accurately represents the recommendations" of an authoritative public health organization. An authoritative public health organization is characterized by CRN as any "agency or department of the U.S. government with public health responsibilities" or "any other public health organization that is recognized as a credible source of information on diet and health." FDA would be required to issue a final rule on an "expedited" health claim within 60 days of the proposal, according to CRN's proposed system. For non-expedited health claim proposals, CRN suggested that FDA should "issue a final rule authorizing or prohibiting the requested use of a health claim" within 120 days of publication of a proposed rule. The council noted that current FDA proposals do not establish a deadline for promulgation of a health claim final rule. CRN also advised FDA to develop a more explicit definition of "significant scientific agreement," the main criterion required by FDA in deciding whether to approve a health claim proposal. FDA's proposed rule states that health claims for supplements, as for foods, will be allowed if the "totality of publicly available scientific evidence" supports the claim and there is "scientific agreement among qualified experts that the claim is supported by such evidence" ("The Tan Sheet" June 21, p. 4). CRN indicated that this description is not specific enough. The Nonprescription Drug Manufacturers Association suggested in Aug. 17 comments to FDA that, when reviewing significant scientific agreement to authorize a health claim, the agency could turn to "a health organization that is accepted as a credible source and/or a significant number of qualified experts [who] agree that publicly available peer-reviewed studies adequately substantiate the claimed relationship." In general, a health claim review process should be "established in a way that assures open, unbiased scientific debate with determinations based on case-by-case, weight-of-the- evidence findings of significant scientific agreement for disease/nutrient relationships," NDMA concluded. Taking the arguments of CRN and NDMA a step further, the National Nutritional Foods Association suggested in Aug. 17 comments that FDA should rely on "significant scientific evidence" rather than "significant scientific agreement" in deciding whether to allow health claims. Significant scientific evidence "may be qualified by FDA to ensure truthful and not misleading claims," NNFA said. NNFA argued that allowing claims based on significant scientific evidence would allow information to "reach that portion of the consuming public that wants to be presented with the opportunity to make informed choices about their health through the use of dietary supplements." FDA must "promote the dissemination of new information derived from respected sources even though certainty has not been reached in the scientific community," NNFA maintained. Similarly, CRN criticized FDA for not allowing the dissemination of "truthful information not in the form of [an authorized] health claim." CRN faulted the agency for interpreting NLEA in such a way that prohibits the inclusion of labeling information on current scientific research implying a nutrient/disease relationship without "going through the cumbersome NLEA process" for health claims. Among other comments on the health claim proposal, NDMA challenged FDA's position that vitamins consumed at levels above those that are normally characteristic of foods to achieve a "therapeutic effect" are drugs rather than foods. NDMA noted, for example, that vitamin E supplements at 400 IU daily are associated with a reduced risk of heart disease. "This dose . . . is almost impossible to obtain in a balanced diet yet this level has been determined to be safe and can easily be achieved through use of dietary supplements," NDMA explained. Moreover, "decreasing the risk of an outcome does not equate to prevention of an outcome . . . [and] should not be considered a therapeutic claim and vitamin E should not be considered a drug," the trade group insisted. "FDA should be open to circumstances where a health claim on a dietary supplement may be more appropriate than on a food," NDMA concluded. NNFA concurred with NDMA in its comments, citing niacin, which has been associated with reducing elevated blood cholesterol levels, as an example of the agency's "functional incapacity to address how a vitamin or mineral might be considered for a health claim in a dietary supplement that [is] plainly not appropriate for addition to the conventional food supply." Other suggestions offered by the trade groups included a CRN idea to establish a separate FDA center for dietary supplements as well as an advisory committee to ensure that the standards for dietary supplements versus conventional foods are applied "even- handedly." In addition, both CRN and NDMA emphasized to the agency that dietary supplements with a history of safe use should not be subject to the same rigors as supplements whose history of use is unknown. While CRN stated that FDA should not require dietary supplements with a "history of safe use to submit information equivalent to that required for a GRAS [generally recognized as safe] or food additive petition," NDMA embraced a system where safety concerns are "defined in terms of whether or not the ingredient may result in injury under the conditions for use defined by its labeling . . . not on an arbitrary cut-off." NDMA added that safety reviews should be undertaken on a case-by-case basis where FDA has determined that a potential problem might exist."