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 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. The bill includes several provisions that were key to earning the Natural Products Association’s support.

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.

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.

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.

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

“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 www.naturalproductsassoc.org/AERs.

22 December 2006 | Uncategorized | Comments