NNFA Statement on Adverse Event Reporting Legislation

Bill exempts retailers, provides flexibility in reporting for manufacturers

WASHINGTON (June 21, 2006) – The National Nutritional Foods Association supports the introduction today of S.3564 – the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the “AER bill”). NNFA believes this bill represents a fair and meaningful collaboration among the supplement industry, our bi-partisan champions in the Senate, and legislators who would like to see more stringent oversight of dietary supplements.

If S. 3564 becomes law, it 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 includes several provisions that were key to earning NNFA’s support. These include requiring that the bill:

Be limited to serious adverse events and not require reporting of just any complaint
NNFA 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

NNFA 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.

Be limited to products sold in the United States

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.

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.

While NNFA understands that the mandatory reporting requirements of the AER bill will add to manufacturers’ record keeping 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 for some time – that the safety record of dietary supplements is exemplary, especially when compared to other health-related products.

Ultimately, safety reporting is the right thing to do. A responsible industry and responsible manufacturers put consumers first. An industry system that puts consumers first will increase consumer confidence and will accrue the corresponding benefits.


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