August 2004

California considers AER bill

California lawmakers are considering a bill that would require supplement companies selling products in California to report adverse events (AERs) each quarter. The proposed legislation is similar to federal legislation supported by Senators Orrin Hatch, Tom Harkin and Richard Durbin.

According to a story posted on the Natural Products Industry Insider Web news (www.naturalproductsinsider.com), the proposed California bill (S.B. 779) would require manufacturers and distributors of dietary supplements to submit copies of AERs quarterly to the California Department of Health Services. The bill would also authorize the department to charge a fee to cover the cost of reviewing the materials.

The story quotes Michael McGuffin, president of the American Herbal Products Association (AHPA) as saying, “It is imperative that our industry continue to oppose this badly conceived bill that threatens to create a state-by-state burden on all of us. It is equally essential that we do everything possible to ensure passage of legislation in the U.S. Congress that would create an AER system where it belongs — in federal regulations.”

The National Nutritional Foods Association (NNFA) also opposes the bill. In a posting on its Web site, NNFA says, “If S.B. 779 is enacted, it would duplicate federal legislation efforts currently underway by requiring manufacturers of dietary supplements sold in California to report to both federal and state governments. Since the bill doesn’t designate any money for this redundant system, manufacturers will foot the bill. Double the work means higher prices for everyone and consumers will bear the brunt of this bill.”

The text of S.B. 779 is available on www.leginfo.ca.gov/bilinfo.html.

Sources: Natural Products Industry Insider Web news www.naturalproductsinsider.com, National Nutritional Foods Association, www.nnfa.org

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