The Controversy Surrounding Ephedra
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.
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