University of Minnesota Seminar Supports Improving AER System for Supplements

Washington, D.C. (July 6, 2004)—The recent conference on Adverse Event Reports (AERs) held at the University of Minnesota highlighted the importance of an improved system for reporting serious adverse events relating to dietary supplements, according to the trade associations of the dietary supplement industry.

The seminar–Adverse Event Reporting and Dietary Supplements: Towards a National System of Surveillance–co-sponsored by the College of Pharmacy at the University of Minnesota, the Utah Natural Products Alliance and the other industry trade associations–featured presentations by Kenneth Falci, Ph.D., Center for Food Safety and Applied Nutrition; Rick Kingston, Pharm.D., College of Pharmacy at the University of Minnesota and SafetyCall International; Michael McGuffin, American Herbal Products Association; Douglas Bierer, Ph.D., Consumer Healthcare Products Association; Annette Dickinson, Ph.D., Council for Responsible Nutrition; Mark Blumenthal, American Botanical Council; and several researchers from the University of Minnesota.

The recent agreement by Sens. Orrin Hatch (R-UT), Tom Harkin (D-IA) and Richard Durbin (D-IL) to work together to pass legislation for a mandatory reporting system of serious AERs for dietary supplements made this seminar a timely opportunity for discussion on such a system and the important role the trade associations will play in helping develop the right kind of mandatory AER system.

The trade associations were also encouraged by the attendees’ interest in further exploring a broader voluntary, third-party AER system that would improve the quality of reports and provide context for evaluating their significance. Participants were encouraged to communicate through their trade associations their specific interest both in development of a mandatory AER system for serious events as well as next steps on improving the voluntary system.

According to Dr. Kingston, who works with other industries on developing useful AER systems, “This is a unique opportunity [for the dietary supplement industry] to step up to the plate. The right AER system will create an asset for the industry for [dietary supplement] products that I believe inherently have a wide margin of safety.”

Contacts: AHPA – Karen Robin (301) 588-1171 x107
CHPA – Elizabeth Assey (202) 429-9260
CRN – Judy Blatman (202) 204-7962
NNFA – Tracy Taylor (202) 223-0101
UNPA – Loren Israelsen (801) 474-2572