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President Bush Signs Dietary Supplement and OTC Bill on Mandatory Adverse Event Reporting


Thursday, April 03, 2008
Compliance


December 27, 2006 - 2:14 PM
WASHINGTON, Dec. 22 /PRNewswire/ -- The Natural Products Association (formerly NNFA) praised President Bush's signing into law today of the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the "AER bill"), S. 3546. The legislation, which had cleared the 109th Congress in its final hours, will amend the federal Food, Drug and Cosmetic Act to require the reporting of "serious" adverse events for both over-the-counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration.

The bill was overwhelmingly supported by dietary supplement retailers and suppliers who welcomed its passage as further proof that the industry is well-regulated and committed to consumer safety.

"Our top priority is providing the products that people want to lead healthier, more fulfilling lives," said David Taylor, president of the Natural Products Association. "So we welcome and support reasonable legislation like this because it will help consumers and the public understand what we have known for some time -- that our industry is made up of good people who make good products and stand by them."

The bipartisan legislation was introduced in the Senate in June of this year by Sens. Orrin Hatch (R-Utah), Tom Harkin (D-Iowa) and Richard Durbin (D-Ill.) and includes several provisions that were instrumental in earning the Natural Products Association's support. Among these key provisions are those requiring that only serious adverse events, not just any complaint, be reported; exempting retail stores from reporting directly to the FDA and preempting a potential patchwork of state laws on the issue.

"The industry has long supported passing this legislation and views it as the responsible, right thing to do," said David Seckman, the Natural Products Association's executive director and CEO. "This law is further proof that the dietary supplement industry is well-regulated and puts consumers first."


The Natural Products Association (www.NaturalProductsAssoc.org) is the nation's largest and oldest non-profit organization dedicated to the natural products industry. The association represents nearly 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health and beauty aids.

Contact: Tracy Taylor, Natural Products Association, (202) 204-4723; (202) 641-3752 - after hours.

Source: Natural Products Association

Web site: http://www.naturalproductsassoc.org/




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