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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT PROPOSAL COMMENT PERIOD EXTENDED TO DEC. 15, FDA announced in an Aug. 17 Federal Register notice. The comment period for the June 18 advance notice of proposed rulemaking -- which requested public comment on mechanisms to ensure the safety of dietary supplements, as well as on the Task Force on Dietary Supplements' Final Report and the Federation of American Societies for Experimental Biology's report on amino acids -- was originally set to end on Aug. 17 ("The Tan Sheet" June 21, p. 1-11). FDA emphasized in the notice that extending the comment period by 120 days "in no way limits the agency's ability to take appropriate regulatory action against dietary supplement products." In July, Center for Food Safety and Applied Nutrition Director Fred Shank, PhD, predicted that it was "likely" that FDA would extend the 60-day comment period in response to requests from interested parties ("The Tan Sheet" July 19, p. 12). FDA explained that it extended the comment period for an additional 120 days because "the agency recognizes that the advance notice of proposed rulemaking requested comments to a number of questions and two additional reports . . . and that additional time may be required to develop and coordinate this information so that the comments are useful to the agency." FDA received requests for a 120-day extension of the comment period from the Nonprescription Drug Manufacturers Association, Lederle Consumer Health, the National Nutritional Foods Association and vitamin manufacturer Solgar. Most of the requests for extending the comment period argued, in the words of NDMA, that "the 60 days provided for comment are inadequate in light of the length of the notice, the data sought by the agency, and the need for industry to review the extensive dietary supplements task force report" and the FASEB report. Solgar added that, in deciding whether to extend the comment period, FDA should keep "in mind the need [for commenters] to evaluate and consider the [Nutrition Labeling & Education Act proposed] regulations which were also published in the June 18 Federal Register, and which are under statutory time constraints." In the Aug. 17 notice, FDA acknowledged that it would be difficult for interested parties to comment on both the ANPR and the NLEA proposals by Aug. 17 (see related stories, beginning below, for comments received by FDA on the NLEA proposals). FDA pointed out that "the most compelling reasons for an extension of the comment period," however, were letters that "promised to provide the agency with scientific and other substantive information on dietary supplements." For instance, supplement manufacturer Metabolic Maintenance Products, Inc. explained to FDA that "research is being collected and organized on the safety and lack of toxicity of amino acids by qualified scientists on behalf of the NNFA." In addition, Metabolic Maintenance Products noted that an amino acid steering committee is being formed by the industry. "It is our goal," the company said, "to have the initial documents presented to the FDA within 120 days." After FDA reviews the documents, "our committee would like to establish a dialogue directed at the FDA's concerns regarding these substances," MMP said. "However, without an adequate amount of time to collect and organize this data, a meaningful and lasting dialogue cannot take place." FDA said it disagreed with requests to extend the comment period for one year; such requests were submitted by the Council for Responsible Nutrition, Perrigo and Banner Pharmacaps. CRN, for one, argued that "because of congressional activity in the area of dietary supplements," it would be "inappropriate for FDA to proceed with the rules proposed in the ANPR before Congress completes its assessment of these issues." Referring to the CRN argument, the agency declared that it "would be remiss in fulfilling its responsibilities under current law if it were to wait one year in anticipation of new legislation that may or may not be developed for the regulation of dietary supplements. It is not unusual for FDA to be conducting an administrative process while Congress is considering legislation on the same topic." Because the "next step in the administrative process" for the ANPR will be a proposed regulation open for comment, FDA concluded that it is "not convinced that there is merit in waiting a year in anticipation of legislative changes that may not occur."

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