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NIH Conference on Multivitamins/Minerals Calls for AER System, MedWatch Labeling on Supplement

(Silver Spring, MD, May 18, 2006) -- The American Herbal Products Association's (AHPA) Steven Dentali, PhD, appeared before the NIH State-of-the-Science Conference on Multivitamin/Mineral Supplements (MVMs) and Chronic Disease Prevention held in Bethesda, Maryland on May 15–17, 2006. The conference was convened to consider questions regarding the public use of MVMs, their safety, efficacy, and major knowledge gaps and research opportunities regarding their use.

The meeting culminated with the release of a draft statement by the conference panel, which addressed a number of MVM issues and also “found … compelling” a statement contained in a 2005 report by the Institute of Medicine (IOM) on dietary supplements that “the regulatory mechanisms for monitoring the safety of dietary supplements, as currently defined by DSHEA, be revised.” The conference panel's draft statement went on to say that “a formal, mandatory, adverse-event reporting system for dietary supplements” be developed, and that “provision of a MedWatch toll-free telephone number/Web site on product labels to facilitate reporting of adverse events” be mandated.

“I was provided with an opportunity at this conference to comment on the position that AHPA has taken for several years in support of mandatory serious adverse event reporting,” said Dr. Dentali, AHPA’s vice president for scientific and technical affairs. “I am pleased that this panel has now come to agree with AHPA on this matter. But placement of MedWatch contact information on supplement products is no more appropriate for this class of goods than for conventional foods, prescription drugs, hazardous consumer products, or pesticides — none of which are held to such a requirement.”

The draft statement also suggested that FDA “should have the authority to better inform consumers and health professionals regarding the existence of ULs [upper levels of nutrients, defined as ‘the maximum daily intake likely to pose no risk of adverse health effects’] as well as the possible risks of exceeding those levels.”

“Frankly, it is quite surprising that the conferees were not aware of the fact that FDA already has this authority,” added Dentali.

The primary sponsors of the conference were the Office of Dietary Supplements and the Office of Medical Applications of Research, both at the National Institutes of Health. The draft conference statement is posted at The final statement is expected to be posted in six weeks.


The American Herbal Products Association (AHPA) represents the core of the botanical trade -- 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 quality with respect to the way herbs are manufactured, labeled, and sold. Website:

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