Bush Signs AER Bill

WASHINGTON--Following the last-minute approval in the final 2006 sessions in both the House and the Senate, President Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546) on Dec. 22. The legislation, which requires mandatory submission of serious adverse event reports (AERs) involving either dietary supplements or over-the-counter (OTC) drugs, will go into effect on Dec. 22, 2007.

Under the bill, manufacturers will be required to notify the Food and Drug Administration (FDA) within 15 business days of any reports of any serious AERs associated with their products. The bipartisan legislation was cosponsored by Sens. Orrin Hatch (R-Utah), Tom Harkin (D-Iowa) and Richard Durbin (D-Ill.), as well as Rep. Chris Cannon, and was supported by many consumer and industry trade groups.

We have long said passing this legislation is the responsible, right thing to do for both the industry and consumers, said David Seckman, executive director and chief executive officer (CEO) of the Natural Products Association, offering thanks to its members who overwhelmingly supported the legislation. We would also like to thank all those grassroots supporters who sent thousands upon thousands of messages to Congress urging their legislators to pass this bill.

This bill was passed by unanimous consent in the Senate and by more than a 2 to 1 majority in the House, stated Michael McGuffin, president of the American Herbal Products Association (AHPA). Such broad and bipartisan support for this important legislation is significant.

Steven Mister, president and CEO of the Council for Responsible Nutrition (CRN), said: With this law, consumers can be assured that if they report to a manufacturer a serious adverse event they believe may be associated with a supplement product, the agency that regulates this industryFDAwill be made aware of that report. He added the more than 150 million Americans who use dietary supplement products deserve no less than the security offered by this bill. We are confident that ultimately the AER system will highlight the strong safety record of dietary supplements and allow consumers to feel increased confidence about the choices they make when taking dietary supplements, he said.

This is a very important piece of legislation that advances consumer interests within a safe, credible dietary supplement marketplace, stated attorney James S. Turner, chairman of the board of the grassroots consumer group Citizens for Health.