(Silver Spring, MD, October 7, 2005) -- In two separate communications dated October 4, 2005, AHPA challenged both the Food and Drug Administration (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, 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,” 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 includes 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 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 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,” McGuffin said. “We ask nothing more, or less, than that.”
The letters and their support documents are posted on the AHPA website:
Letter to Dr. von Eschenbach (October 2005)
Enclosure: Letter to Dr. McClellan (April 2003)
Enclosure: AHPA comments on cGMP (August 2003)
Letter to Dr. Straus (October 2005)
Enclosure: Echinacea dosage citations (September 2005)
* Turner RB, Bauer R, Woelkart K, et al. An evaluation of Echinacea angustifolia in experimental rhinovirus infections. NEJM. 2005 July 28; 353(4):341-8.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org