American Herbal Products Association (AHPA) President Michael McGuffin presented new findings from the first six months of mandatory serious adverse event reporting (SAER) yesterday at the SupplySide East Trade Show and Convention held April 27-29 at the Meadowlands Exposition Center in Secaucus, N.J.
Since Dec. 22, 2007, the dietary supplement and over-the-counter drug industries have been reporting all SAERs to the Food and Drug Administration (FDA) in accordance with Public Law 109-462, “The Dietary Supplement and Non-Prescription Drug Consumer Protection Act.” Since implementation of the Act, AHPA has been submitting Freedom of Information Act (FOIA) requests with FDA for all adverse event reports filed for products identified as dietary supplements. The information presented yesterday represents AHPA’s analysis of the reports submitted between Jan. 1, 2008 and June 30, 2008.
“Data shows the SAER system is functioning as a signal generator and demonstrating the safety of our class of goods,” said McGuffin. “The dietary supplement industry fought hard for this good law, and AHPA is encouraged to see it working so well in its first six months.”
McGuffin’s presentation – which includes report breakdowns by product category, age, gender, and other criteria – is available online: http://www.ahpa.org/portals/0/pdfs/09_0429_MMcGuffin_SSE.pdf
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our 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 herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.