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ANTIOXIDANT VITAMIN HEALTH CLAIM DECISION-MAKING BY FDA

This article was originally published in The Tan Sheet

Executive Summary

ANTIOXIDANT VITAMIN HEALTH CLAIM DECISION-MAKING BY FDA should focus on whether there is scientific agreement that the wording of a claim has "sufficient scientific basis," Kellogg Associate General Counsel Marilyn Schramm asserted in Nov. 22 comments to FDA. To date, Schramm maintained, "FDA's policy choices in the area of health claims . . . seem constrained by an overcautious and unnecessary focus on demanding significant scientific agreement concerning the ultimate efficacy of the subject nutrient/disease relationship." For "purposes of health claim authorization," Schramm outlined, "the question is not merely whether antioxidant vitamins prevent disease." Instead, she argued that "there should be a series of questions to be addressed." The first question, she maintained, is whether there is "competent and reliable evidence suggesting a relationship between a nutrient and disease that is worthy of dissemination to the public." If that is the case, Schramm continued, "what statement about that relationship can be made based upon the existing body of research?" Once a claim is developed, she added that "there must, of course, be significant scientific agreement that the available body of evidence supports the claim." The Kellogg lawyer suggested that FDA adopt an approach to health claims that is "guided by a desire to provide as much scientifically based information to the public as possible, albeit worded and framed in such a way that there would be significant agreement in the scientific community that the health claim is properly supported and is accurate, truthful and nonmisleading." Schramm's comments respond to FDA's Nov. 1-3 public conference on antioxidant nutrients and cancer/cardiovascular disease, where the agency asked panels of invited scientists to discuss whether available data on vitamin E, vitamin C and beta carotene support health claims for those nutrients ("The Tan Sheet" Nov. 8, pp. 15- 21). A transcript of the meeting has been submitted by FDA as a comment on its October proposal to disallow dietary supplement health claims for antioxidants and four other nutrient-disease relationships ("The Tan Sheet" Oct. 11, p. 1). Schramm complained that FDA did not provide invited scientists at the antioxidant conference with a "specific claim to consider" and, therefore, "addressed the issue in terms of cause and effect, i.e., whether a given antioxidant vitamin has an effect on one's risk of contracting disease." "It is the nature of science," Schramm attested, "particularly in this area of diet and health, that certainty cannot be achieved easily, if at all, regarding cause-and-effect relationships between nutrients and diseases." The Kellogg general counsel added that "it is also the nature of scientists to continue to probe, ask more questions and pursue further research." Therefore, Schramm asserted that FDA "needs to be willing to make the difficult but necessary and important public policy 'leap of faith' in approving health claims." If FDA delays approving health claims "until a level of certainty is achieved regarding cause and effect," she suggested that "more harm will have been done through this omission than would have been done by approval of a claim that later needs refinement." The Kellogg attorney recommended that FDA "approve health claims that reflect the current state of scientific evidence where there is significant scientific agreement that sufficient evidence exists to support the claimed nutrient-disease relationship." Schramm also asserted that good public health policy "calls for focusing as much attention and concern on increasing the flow of truthful information about diet and health as on the prevention of deception or the mere potential for confusion." If FDA adopts this approach, Schramm maintained, the agency "would likely strike the proper balance between consumer protection and consumer education," which would "bring about consistency between FDA's and [the Federal Trade Commission's] respective approaches to regulation of health claims in labeling and advertising." In separate Nov. 4 comments to FDA on antioxidants and cancer/heart disease, Richard Passwater, PhD, Solgar Nutritional Research Center, asserted that there is adequate evidence for FDA to authorize an antioxidant health claim. He argued that a "delay in bringing this information to the public will result in a needless increase" in cancer and heart disease mortality and morbidity. "We will never have perfect data," Passwater said, and "we owe the public our best information and advice." Acknowledging that "the evidence is strong for the antioxidant nutrients as a team, but weaker for the individual members of the team," Passwater suggested that "the health claims can deal with the importance of a diet rich in all of the antioxidant nutrients." Passwater also disputed assertions made at the Nov. 1- 3 FDA conference that vitamin C is detrimental to hemochromatosis patients, charging that the argument is "just a straw man to delay health claims for antioxidant supplements." The safety of vitamin C, he maintained, "is well established and megadoses have been under intense scrutiny for decades."
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