The Controversy Surrounding Ephedra
By Al Alexander
The Chinese discovered ephedra in the form of the Ma Huang plant more than 5,000 years ago and it is the basis of Traditional Chinese Medicine. The Chinese have long used ephedra to treat colds and flus, fever, and many other symptoms. Recent research has shown that ephedra increases metabolism, promotes weight loss and fat burning, curbs your appetite, relaxes the air passages in the lungs to help treat asthma and cough, and helps promote urination to relieve water retention.
Concerns about the cardiovascular effects of ephedra use, including increased blood pressure and irregular heart rhythm led the FDA to ban ephedra diet supplements in April 2004. The ban on ephedra did not pertain to traditional Chinese herbal remedies nor to products like herbal teas that are regulated as conventional foods. The ban also did not effect ephedrine or pseudo ephedrine supplements. This was the first time the FDA exercised its power to stop the sale of a dietary supplement ingredient and it prompted protest from the dietary supplement industry.
Consumer reaction to the ban was mixed. While the FDA's alarm may have deterred some, many devoted ephedra users found ways to circumvent the ruling. A government survey following the ban found that many New Yorkers were using "copycat products to achieve effects similar to ephedra's. Government officials called for a ban on the copycat products as well, but their calls were silenced by the next judge's ruling.
In April 2005 Judge Tena Campbell ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's ban. Nutraceutical Corporation claimed that ephedra has been safely consumed for hundreds of years and that ephedra was being wrongly regulated by the FDA as a drug and not a food. Judge Campbell agreed. And while federal law requires drug manufacturers to prove that drugs are safe before putting them on the market, dietary supplements (classified as a food) are allowed on the market unless the FDA proves that they are unsafe. Since the FDA failed to demonstrate to the judge that ephedra was unsafe in small doses, she lifted the ban on sales of 10 mg or less.
Dr. Cathy Wong, a naturopathic physician, was among those who welcomed the new ruling. She believed a ban on ephedra was harsh and unnecessary, and pointed out that the number of deaths attributed to ephedra is a small percentage of total users compared to the fatality rates of most major (and legal) pharmaceutical drugs.
The FDA, however, stands by its ban on ephedra and suggests that because the ruling allows only dosages of 10 mg or less, the judge has upheld the FDA's claim that higher dosages are harmful. The FDA has not, as yet, taken further steps to reenact the complete ban, and as a result, many of the banned ephedra-based diet supplements are now available again. Supplements like Zenalean, Xenadrine, Ripped Fuel, and Metabolife can be sold legally.