AER Bill Passes Congress—a Victory for Consumers and the Natural Products Community

Washington, D.C.—December 9, 2006—Thousands upon thousands of faxes and e-mails from Citizens for Health members, along with leadership and support from the Natural Products Association and the Council for Responsible Nutrition (CRN), led to victory: the passage of the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the "AER bill"), S. 3546.

The legislation, which cleared the House of Representatives in the small hours of the morning and was passed by the Senate this past Wednesday, will amend the federal Food, Drug and Cosmetic Act to require manufacturers to notify the FDA of all serious adverse events (AEs) for over-the-counter (OTC) drugs and dietary supplements reported to them.

It now goes to President Bush for signature; Citizens for Health urges the President to sign without delay.

“As I said about the House version of the bill, this is a very important piece of legislation that advances consumer interests within a safe, credible dietary supplement marketplace,” noted attorney James S. Turner, chairman of the board of consumer health grassroots powerhouse, Citizens for Health.

"We have long said passing this legislation is the responsible, right thing to do for both the industry and consumers," said David Seckman, the Natural Products Association's executive director and CEO. "We would like to thank our members, who have overwhelmingly supported this 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."

According to Steven M. Mister, CRN’s president and CEO: “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.”

Not only does the bill show a serious commitment to consumer safety and protection by the dietary supplement industry—it also includes appropriate safeguards so that unjustified burdens are not placed on responsible companies. It emphasizes how well-regulated the dietary supplement industry actually is and how committed supplement companies already are to safety and to making the existing regulations work more effectively.

The bottom line: this legislation supports existing law and provides additional consumer safety protections while also protecting responsible dietary supplement companies from unjustified burdens.

Citizens for Health has a history of not only backing the right legislation—but of also powerfully opposing bills that would have hurt consumers and the industry, such as 2004’s Senate Amendment 3225, a 2004 piece of legislation that would have set an unacceptable precedent that could have undermined the Dietary Supplement Health and Education Act (DSHEA). Citizens for Health generated 25,000 letters to Congress on this, and the bill was withdrawn.

The bill will become effective within one year of its being signed into law and requires that the FDA issue a guidance to industry addressing the reporting requirements within nine months of enactment.

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Contact: James S. Turner, Esq.

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