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November 1, 2005
By: Sean Moloughney
Editor, Nutraceuticals World
In two separate communications dated October 4, 2005, AHPA challenged both the FDA and the National Center for Complementary and Alternative Medicine (NCCAM) to tell the truth and to correct past misstatements about dietary supplements and echinacea products, respectively. “Federal agencies need to demonstrate the same respect for dietary supplements as they do for any other regulated industry,” said AHPA president Michael McGuffin. “AHPA is asking that FDA adopt an overall tone that is respectful of this trade when the final rule on cGMP is published, and that NCCAM correct erroneous statements made in relation to the recent study on low-dose Echinacea angustifolia root preparations.” In a letter to the new Acting FDA Commissioner, Andrew von Eschenbach, MD, Mr. McGuffin sought assurances that when the final rule for current good manufacturing practice (cGMP) is published, FDA will not repeat the errors and misrepresentations that occurred when the proposed rule was published in March 2003 and about which AHPA complained at the time. Those errors were repeated in major media reports and cast doubts on the quality of all dietary supplements and the degree to which this industry is regulated. “AHPA has worked for years with FDA to assure dietary supplement integrity,” Mr. McGuffin said. “We are seriously concerned that the agency be truthful and not misleading when discussing this industry.” The same concern for accurate information from the federal government led to the separate communication to NCCAM’s director, Stephen Straus, MD. In a discussion of a recently published study on low-dose Echinacea angustifolia root preparations, the NCCAM website included an inappropriate and unrelated criticism of herbal products by generalizing that “what’s on the label may not always be what’s in the bottle.” In addition, numerous news articles about this study cited Dr. Straus as defending the low dosage used in the study as the one “most often used by consumers,” and as concluding, “We’ve got to stop attributing any efficacy to echinacea.” In its letter, AHPA asked that the cited criticism “be removed from the NCCAM website immediately,” and that all media outlets that carried Dr. Straus’ statements be requested to “issue corrections to these statements.” “The government agency that is leading scientific research into the use and benefits of supplements has a fundamental obligation to tell the truth,” Mr. McGuffin said. “We ask nothing more, or less, than that.” One week after AHPA sent its letter to NCCAM, the organization revised its website to correct erroneous statements it had made about the study on low-dose preparations of Echinacea angustifolia root published in the New England Journal of Medicine on July 28, 2005.
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