Natural Products Association Applauds Passage of Adverse Event Reporting Legislation

Bill benefits industry, consumers

WASHINGTON (December 9, 2006) – The Natural Products Association applauds Congress for passing the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the “AER bill”), S. 3546. The legislation, which cleared the House of Representatives early this morning and was passed by the Senate last Wednesday, 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. It now goes to President Bush for signature.

“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.”

The bipartisan bill was introduced in June of this year by two of the dietary supplement industry’s most ardent supporters in Congress, Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa). The bill includes several provisions that were key to earning the Natural Products Association’s support. These include requiring that the bill:

Be limited to serious adverse events and not require reporting of just any complaint
The Natural Products Association believes that adverse events potentially related to dietary supplements will be minimal and serious adverse events rarer still. Having a reliable and verifiable system that attests to the safety of dietary supplements will end negative speculation by critics of the dietary supplement industry.

Not require retailers to report adverse events from customers to the FDA
The Natural Products Association believes adverse event reports should come from the company that manufactured, packaged or distributed the product, not the retailer. With this bill, even retailers who sell products under their own label will not be required to report adverse events to the FDA.

Include OTC drugs
If dietary supplements and prescription drugs have an adverse event reporting framework, it only makes sense that OTC drugs should, as well. Currently, only those OTC products that were once prescription are required to report.

Include a state preemption provision
In the absence of a federal bill, several states have introduced legislation mandating various reporting requirements for dietary supplement adverse events. Requiring manufacturers to comply with a patchwork of laws for different states would be overly burdensome; this bill will prevent this from happening.

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.

While the Natural Products Association understands that the mandatory reporting requirements of the AER bill will add to manufacturers’ recordkeeping responsibilities, the association believes the bill will benefit the industry in the long run. First, by helping to change the perception by critics of the dietary supplement industry that it is not well regulated. Second, over time, the recordkeeping and reporting requirements will substantiate what many in the industry have been saying: that the safety record of dietary supplements is exemplary, especially when compared to other health-related products.

“A responsible industry and responsible manufacturers put consumers first,” said Seckman. “An industry system that puts consumers first will increase consumer confidence and will accrue the corresponding benefits.”


Tracy Taylor

Natural Products Association
(202) 223-0101, ext. 103

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