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

Natural Products Association Supports Law, Says New Requirements Will Illustrate Exemplary Safety Record of Supplements

President Bush today signed into law 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 (FDA).

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.”

Taylor went on to thank the association members and consumers who sent tens of thousands of messages to Congress asking their legislators to support the bill.

The bipartisan bill was introduced in June of this year by two of the dietary supplement industry’s strongest 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
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 prevents that from happening.

Be limited to products sold in the U.S.
Requiring manufacturers to report adverse events from products used overseas is neither practical nor reasonable.

Allow third parties to report or evaluate claims
If a manufacturer, distributor or packager of a dietary supplements wishes to arrange for a third party to meet the provisions of this law in regard to their products, they are free to do so.

The bill will take effect one year from its being signed into law and requires that the FDA issue a guidance to industry addressing the reporting requirements within nine months of enactment. To assist members in making the transition from voluntary to mandatory reporting, the association will be providing information and educational opportunities.

“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.”

Look for more information about implementation of this bill in upcoming issues of Natural Products Association Now and on the Natural Products Association Web site at

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