FDA Ban About More than Ephedra

This spring the FDA puts its foot down to the herbal supplement, well kind of.

| March/April 2004

A federal ban on the herbal supplement ephedra that’s set to take effect this spring has the supplement’s detractors breathing a sigh of relief, while many in the herbal medicine community hold their breath and wonder when the other shoe will drop.

For many years, ephedra has been the problem child of dietary supplements, accounting for 64 percent of all serious supplement side effects reported to the Centers for Disease Control and Prevention. Considering the thousands of herbal supplements available, that’s a worrisome statistic. Used for weight loss and to increase energy, the supplement has been associated with numerous adverse reactions, including heart attacks, strokes and at least two deaths. Many associated with herbal medicine regard the Food and Drug Administration’s long-anticipated decision as an opportunity to put this quarrelsome issue to rest and move on to more serious debate about the many effective herbs that could improve the health of U.S. citizens.

As it turns out, that response might be premature and even a bit naive. What’s at stake here isn’t simply whether or not Americans can buy ephedra, it’s whether the FDA has the power and authority to remove a product it believes to be unsafe — a topic of debate since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Awaiting action in the U.S. Senate and House of Representatives is legislation critics say would greatly limit consumers’ freedom of choice and vastly increase the challenge and cost of producing herbal supplements — to the point of driving many companies out of business. Whether the FDA ban survives any challenges will shape the debate over more stringent legislation.

“The FDA has been saying for years that it doesn’t have the power to remove a product it believes to be unsafe,” says Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), a nonprofit organization dedicated to disseminating accurate and reliable information on herbs and medicinal plants. “If one of the manufacturers challenges the ban and loses, ephedra will go off the market and the FDA’s claim (that it doesn’t have enough authority to remove harmful substances) will go away.

“However, if someone challenges, wins and ephedra stays on the shelves, the FDA will say DSHEA doesn’t give it enough teeth and new legislation is required for FDA to protect the public.” Although its sponsors tout their bills as more regulatory muscle to protect American citizens, its consequences might be bad news for the herbal supplement industry and for consumers. One such piece of proposed legislation (S. 722, sponsored by Sen. Richard Durbin, D-Ill.) would give the FDA the power to remove an entire class of supplements from the market if there is a single serious adverse reaction complaint filed, even if the complaint is filed by someone who used the supplement in contradiction to the instructions and warnings of the manufacturer. No pharmaceutical drug is required to meet such standards.

One of the oldest and most widely used Chinese herbs, ephedra — also known as ma huang — has been used for thousands of years in Traditional Chinese Medicine (TCM) as a primary component of formulas prescribed to treat asthma, colds and flu, coughs, wheezing and nasal congestion. (For more information on ephedra, check out the ABC website, www.herbalgram.org.) If the ban is enacted, Blumenthal says he expects the herb still will be available to TCM practitioners.



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