April 14, 2005
Judge Strikes Down Ephedra Ban
By Jeff Stier, Esq.
Given today's federal judge's ruling striking down the FDA's ban of the
dangerous natural weight-loss supplement, ephedra, we would like to
remind you what we said about the matter when the FDA first made the
decision. This commentary is only more relevant today...
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FDA vs. Congress on Ephedra Ban
Jeff Stier, Esq.
published on January 9, 2004
The Food and Drug Administration's announcement of its intention to ban
weight loss or "athletic performance enhancing" products containing
ephedra is good news. However, it took over 100 deaths, including that
of a major league baseball player, over 10,000 recorded complaints, and
countless scientific studies for the FDA to ban this dangerous
supplement. Because of the 1994 Dietary Supplement Health and Education
Act (DSHEA), which limited FDA's authority to regulate dietary
supplements, the FDA still can't be sure that it has met the regulatory
burden to enact the ban; manufacturers are likely to sue.
Ephedra should have been banned a long time ago. If it had been
considered a pharmaceutical product and thus subject to the same
scientific standards, ephedra would not have made it to market in the
first place. However, as a supplement regulated under the DSHEA,
ephedra was marketed without any proof of efficacy - or studies
showing that the supplement is safe. In fact, under DSHEA, the
government, not the manufacturer, shoulders the burden of proving a
product is dangerous (rather than the manufacturer proving it is safe,
as is the case with pharmaceuticals). There is in place a double
standard for dealing (harshly) with pharmaceuticals and food additives
vs. dealing (leniently) with supplements, and this is intolerable. The
DSHEA is handcuffing the FDA's efforts to protect public health - and
the only ones benefiting from the law are manufacturers who cannot
present scientific data about the safety (let alone efficacy) of their
"natural" products.
Why the disparity in treatment between synthetic pharmaceuticals and
"natural" supplements? Dietary supplements (products you might expect
to find in a "health food" store, not a pharmacy) are assumed to be
safe unless chemically altered or adulterated in some form. The
misconception lies in the notion that anything present in nature must
be healthy and anything synthetic must be dangerous. But as the country
has found with ephedra, this is not necessarily the case.
Even when the FDA attempts to act within its powers, little may be
done. In 1997 when the FDA first attempted to regulate ephedra by
requiring warning labels and dosage restrictions, the move to protect
public health was blocked. Why? Because the FDA had not met the
excessive burden of proving that there was "significant or unreasonable
risk of injury" associated with the use of ephedra. Is it possible that
the death of the Baltimore Orioles pitcher Steve Belcher in 2003 and
the pain and misfortune of many other ephedra users could have been
avoided? That is a question DSHEA's congressional authors will surely
struggle with.
The regulations the FDA is attempting to enact will only affect the
sale of ephedra, not the regulatory system itself or the problems that
allowed ephedra to remain on the market for so long. If the ban on
ephedra is enacted, it may serve as a good precedent for proceedings
against other supplements, but it will not grant the FDA the broader
power necessary to protect the public health from dangerous
supplements.
As the nation becomes increasingly health-conscious but also vulnerable
to "quick fixes," Americans are turning more and more to so-called
"natural" remedies, including some dangerous supplements. Sixty percent
of Americans take some sort of dietary supplement every year, and
consumers need realistic and accurate information about the supplements
they take. It is time that Congress rewrote the law to allow the FDA to
better do its job and protect consumers from dangerous supplements.
Jeff Stier, Esq. is an associate director and Kimberly Bowman a
research intern at the American Council and Health.
This information was found online at:
http://www.acsh.org/factsfears/newsID.536/news_detail.asp