Wednesday, May 16, 2007

05/16/07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs


EPHEDRA BAN CONTINUED: Risk - Benefit Analysis Comes to Herbs

The United States Supreme Court decided not to hear the Ephedra case appeal on May 13, 2007. This decision leaves standing the appeal court reversal of the Utah district court's voiding of the FDA's ban on the Chinese herb Ephedra. Take a deep breath! That means, in effect, a drug industry risk/benefit standard has been imposed on at least part of the Dietary Supplement industry. Instead of the standard of “safe if used as directed,” which is the standard that applies to all foods, herbs can now be subjected to the type of analysis that applies to drugs.

But not equally, as the Ephedra case shows. Let's take Aspirin for example: tens of millions use it daily; 1500 die each year. Apply Risk/Benefit Analysis: drug allowed. Another example: Viagra(R) - hundreds of thousands use it; hundreds are harmed yearly. Drug allowed. Now take Ephedra: at its height, 25,000,000 used it daily. Over ten years, there were 5 deaths that may have been associated with Ephedra abuse; not using it according to directions. Result: the herb is banned. To this observer, this does not appear to be equal treatment. Or based on science and reason.

According to NutraIngredientsUSA, "The most recent court ruling on Ephedra blurs the distinction between supplements and drugs and could force the industry to conduct clinical tests, says the Natural Products Association..." The "once-popular herbal, was banned by the FDA's final rule in 2004 on the grounds that it does not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death. ... A year later the ban was successfully challenged by Nutraceutical in a Utah court since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor. ... Since then the pendulum has swung back and forth on appeal..."

Judge Campbell's reasoning, however has not been rejected by the Supreme Court, as it decided in its discretion, not to hear the case. Future cases asserting the same legal claim, that Congress intended Dietary Supplement law to be harmonized with food law, not drug law, could be further strengthened by steps the US Senate took last week to exempt Dietary Supplements when it approved enhanced powers for FDA.

In the 2005 case, Judge Tena Campbell held, “...the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection to the food adulteration provision…”

It is therefore incumbent upon Congress to protect this salutary policy and further enhance it, by writing a much stronger exemption for all foods and natural products into S.1082, the FDA Revitalization Act of 2007 when it comes before the House. Keep your mouse-tail twitching and stay tuned to get ready to bombard Congress with one simple demand:

"Protect our herbs, vitamins, minerals and natural remedies from bureaucratic meddling!!"

Check for further details.

To contact Congress:

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