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Media reports, and the FDA's own releases, have suggested that the
intended targets of the ban are products sold for weight loss, muscle
building, athletic performance, or as an alternative to illicit street
drugs. No doubt there have been egregious abuses by companies
selling such products. Often the products contain ephedrine derived
from artificial sources having nothing to do with the traditional
Chinese ephedra herb. Some companies even sell pure ephedrine
which is highly dangerous.
Traditional Chinese herbal products made from the true ephedra
(Ephedra sinica and others) are thought by some to be excluded
from the ban. However, the FDA's final ruling published on Feb. 6
makes no mention of any provision to exclude products made with
the Chinese herb. Here is the final ruling:
Sec. 119.1 Dietary supplements containing ephedrine
alkaloids.
Dietary supplements containing ephedrine alkaloids
present an unreasonable risk of illness or injury under
conditions of use recommended or suggested in the
labeling, or if no conditions of use are recommended
or suggested in the labeling, under ordinary conditions
of use. Therefore, dietary supplements containing
ephedrine alkaloids are adulterated under section
402(f)(1)(A) of the Federal Food, Drug, and Cosmetic
Act.
The effect of this ruling is far more sweeping than many had
expected. It amounts to a complete ban on anything containing
ephedrine, including the Chinese herb. Even though the ephedrine
in Chinese ephedra is present at relatively low levels, its presence
means that the herb is now considered "adulterated" and is therefore
illegal to sell under the ruling.
Ephedra is one of the most important herbs in Chinese herbal
medicine. To lose access to it is a serious setback to the practice of
a 5000 year old traditional form of herbal medicine in America.
Ephedra is considered one of the best herbs for the treatment of
chills, fevers, cough and wheezing associated with colds and flus.
Chinese herbalists say that ephedra is one of the first herbs that they
are taught to use.
Most herbalists would not object to the banning of products to
which ephedrine is added or concentrated beyond natural levels.
This would be a sensible action for the FDA to take in the face of
industry abuses and the reports of serious adverse reactions
including death. But herbalists believe that the ephedra herb itself
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