New dietary supplement bill

July 5, 2006 - Also Sen. Orrin Hatch is now claiming for mandatory reporting of adverse effects linked to dietary supplements, such as the one that killed a Lincoln teen nearly four years ago.
Under the bipartisan compromise introduced by Hatch, manufacturers will still have the relative freedom that has allowed the manufacture and distribution of dietary supplements to grow into a $20 billion industry.

However, mandatory reporting requirements will replace a voluntary system for informing the Food and Drug Administration of severe health problems believed caused by supplements.

That should let the FDA more quickly identify problems with particular supplements, such as those containing ephedra, which were tied to 155 deaths.

The Food and Drug Administration banned ephedra in 2004. In addition to the deaths of Riggins, Baltimore Orioles pitcher Steve Bechler and others, the FDA received thousands of reports of adverse reactions, such as strokes, seizures and heart attacks.

But a federal judge struck down the FDA ban in April 2005 and the legal battle is continuing. An appellate court ruling is expected this year.

That's what makes the bill sponsored by Hatch and co-sponsored by Durbin and others so important. S. 3546 would establish a mandatory uniform reporting system for adverse health effects related to dietary supplements and all over-the-counter drugs. Manufacturers would be required to include with their products information on how to report health problems. Reports of "serious adverse events" - such as death, life-threatening illnesses or hospitalization - would have to be forwarded to the FDA within 15 days.

This would help the FDA identify problems sooner and better protect the public.


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