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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT PROPOSAL COMMENT PERIOD MAY BE EXTENDED by FDA to allow interested parties more time to present their views, FDA Center for Food Science and Applied Nutrition Director Fred Shank indicated at the Toxicology Forum annual meeting in Aspen July 12. The 60-day comment period provided in FDA's proposed dietary supplement regulations, published in the Federal Register on June 18, currently runs out on Aug. 18. Shank noted that FDA received a letter from "one of the Washington lawyers" who pointed out that "it took the government a little bit longer to get their act together" than interested parties in the dietary supplement industry are being given to respond to the proposal. "I am not announcing that there is going to be an extension but we'll take it under advisement," he said. The FDAer later acknowledged that it is "likely" that FDA will publish an extension of the comment period in an upcoming Federal Register notice. In a July 7 letter, Washington, D.C. law firm Piper & Marbury, on behalf of the National Nutritional Foods Association, requested a 120-day extension of the comment period to early December. The extension is being requested, the letter noted, because the organization "must devote substantial resources to the three regulatory proposals that were also proposed that day: health claims, nutrient content claims and nutrition labeling. ("The Tan Sheet" June 21, pp. 1-11). FDA is required under Sen. Orrin Hatch's (R-Utah) 1992 dietary supplement legislation to publish the final regs by the end of December. Regarding FDA's upcoming Federal Register notice on a health claim for folic acid, Shank maintained that the agency still has not decided on what will be included in the proposal. In a June 15 press release announcing the dietary supplement proposed regs, FDA said it expected to publish in July a proposal "authorizing a health claim and amending the food additive regulation for [use of] folic acid" in the prevention of neural tube defects. Shank said he believes that FDA is "likely to move forward with" a proposal to change "the standard of identity [to require fortification] for 13 cereal grain products." These revisions, he said, "would require the inclusion of folic acid in products in order to qualify as 'enriched.'" Fortifying the food supply may offer advantages, Shank suggested, given "the additional cost of dietary supplements." However, the CFSAN director said he is "confident that [dietary supplements] are going to have a role to play in the so-called intervention strategies as well . . . We think both [foods and supplements] have merits." If FDA decides to allow a folic acid health claim for supplements, Shank noted that the claim may differ from what is allowed for foods. FDA's decision to move forward on a folic acid health claim follows a recommendation by the agency's Folic Acid Subcommittee in April to allow relevant products to claim that daily intake of 400 mcg of folic acid -- either from foods or supplementation -- can reduce the risk of conceiving a child with NTDs ("The Tan Sheet" April 19, p. 3).

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