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FDA DIETARY SUPPLEMENT PROPOSED REG ON HEALTH CLAIMS

This article was originally published in The Tan Sheet

Executive Summary

FDA DIETARY SUPPLEMENT PROPOSED REG ON HEALTH CLAIMS will include essentially the same claims that are in the Nutrition Labeling and Education Act implementing regs for conventional foods, FDA Office of Food Labeling Director Edward Scarbrough said June 4 at a meeting sponsored by the New York Bar Association. However, Scarbrough noted that FDA's final decision on health claims for supplements could significantly change by the December deadline for the final regulations depending on the kind of input the agency receives on its soon-to-published proposed regs. Scarbrough also acknowledged that FDA may have to reconsider claims for vitamin E and other antioxidants in light of recently published studies that were not available when the NLEA regs appeared in January, including two large-scale epidemiological studies published in the May 20 New England Journal of Medicine ("The Tan Sheet" May 24, p. 10). "Since the publication in January [of the NLEA regs(BRACKET), there have been two or three significant studies published [on vitamin E] and I think there are a lot of new data coming out now that are big clinical studies that seem to be well within the rules of good scientific investigation," Scarbrough observed. FDA, he predicted, "is going to be in a position of having to go back and look at those data very quickly." FDA is considering publishing the NLEA implementing regs for dietary supplements in a set of three documents covering the nutrition label format, nutrient content claims, and standards for health claims. In addition, Scarbrough reported that FDA is working on a set of technical amendments to the NLEA regs which the agency hopes to be finished with by the end of June. Although FDA is required by statute to publish the amendments by Aug. 8, the agency has set a July target for publication in the Federal Register, Scarbrough indicated. Regarding daily values for vitamins and other nutritionals, Scarbrough predicted that recommended daily allowances (RDAs) will not be changed in 1993. Noting that the National Academy of Sciences has scheduled a June meeting to consider updating RDAs, he pointed out that the NAS is not likely to make a formal decision on new RDAs until December at the earliest. He suggested that the process for updating the RDAs could take "four to five years." He suggested that NAS' handling of RDAs for vitamin E merits attention given that the long-term health benefits seen in the epidemiological studies was with megadoses of vitamin E.

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