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United Natural Products Alliance (UNPA) Statement On The Status of Federal Dietary Supplement Serious Adverse Event Reporting Legislation

While the Congress did not give its final approval to bipartisan legislation mandating reporting of serious adverse events associated with the use of non-prescription drugs and dietary supplements, we remain hopeful that this important reform will become law in 2006. UNPA will continue to work aggressively for passage of the Non-Prescription Drug and Dietary Supplement Consumer Protection Act (S.3546/H.R.6168) when the Congress reconvenes for a brief “lame duck” session the week after the November elections. Key legislators have indicated that they expect both the Senate and House to take action on the bill during this work period.

Dietary supplements have a very safe track record, so these serious adverse reactions are few and far between. So mandatory reporting will provide better early warning signals in the rare event a serious adverse event occurs. It could, for example, more rapidly identify a batch of products that have been adulterated or tampered with. It will increase consumer confidence in the safety of their supplements and help companies more rapidly identify and correct a problem. And a strong national reporting system will mean that companies won’t have to deal with duplicative or widely varying state or local requirements. States like New York and California have already signaled their interest in such new requirements.

A commonsense mandatory serious adverse events reporting system for supplements is one change under consideration in Washington that truly is a win-win. Passage of the bipartisan proposal al would be a victory for consumers and industry alike. UNPA believes that Congress should not end the year without passing this important change.

The United Natural Products Alliance (UNPA) is an association of leading companies which manufacture, distribute and assure the quality of dietary supplements.

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