Hearing Set on California AER Bill

Hearing Set on California AER Bill

SACRAMENTO, Calif.--The California Assembly Health Committee has scheduled a hearing for June 15 to review California Senate Bill 779, which would require manufacturers and some distributors of dietary supplements to submit adverse event reports (AERs) to the Department of Health Services (DHS) on a quarterly basis. The bill has been inactive since July 2003, but was recently sent back for consideration with amendments concerning distributors' responsibilities in AER reporting. Sen. Jackie Speier (D-San Francisco/San Mateo) has been a vocal opponent of current dietary supplement regulation, and was the lead sponsor on the legislation banning ephedra in California prior to the Food and Drug Administration's (FDA) federal action.

Organizations in the dietary supplement industry have raised a number of concerns about the bill. The Consumer Healthcare Products Association (CHPA), for example, argued the new legislation fails to adequately define AERs and doubles existing reporting requirements. General Nutrition Corporation (GNC) stated the required funding for the program from the dietary supplement industry is untenable, and argued the program lacks guidelines for allocation of funds and how the collected AER information will be used. Several groups, including the American Herbal Products Association (AHPA), have voiced serious concerns about creating a a single-state system on AERs, particularly as FDA is working on enhancing its own AER system.