A year ago, the Food and Drug Administration (FDA) banned dietary supplements containing the herbal stimulant ephedra. In a decision that was recently overturned by a federal judge in Utah, the FDA concluded that all such products are "adulterated" because they pose an "unreasonable risk of illness or injury."
Yet, the FDA took no action against over-the-counter medicines, such as Primatene and Bronkaid, that contain ephedrine, the most potent stimulant in ephedra, or the many cold and allergy remedies that contain pseudoephedrine, another alkaloid found in the plant. These products are considered safe and effective drugs, rather than unreasonably risky dietary supplements.
To make things even more confusing, the FDA also continued to allow the use of ephedra in traditional Asian medicine because its practitioners "typically do not use products marketed as dietary supplements." Hence, loose, dried ephedra prescribed by herbalists remained legal, while exactly the same substance was prohibited when chopped up, placed inside a capsule, and sold in a health food store.
This strange situation is largely a result of a 1994 law aimed at limiting the FDA's authority over dietary supplements. The law and the FDA's interpretation of it are part of a continuing struggle over how much freedom Americans should have to control their own health.
The FDA decided that dietary supplements containing ephedra, used mainly as energy boosters and weight loss aids, were unacceptably dangerous because, in its judgment, their risks outweighed their benefits. The agency thereby asserted its authority to impose that determination on consumers who, once informed of the risks, might have arrived at a different conclusion.
On April 14, in response to a lawsuit brought by Nutraceutical Corp. and its Solaray susidiary, U.S. District Judge Tena Campbell ruled that the ephedra ban violated the Dietary Supplement Health and Education Act (DSHEA). "The FDA's imposition of a risk-benefit analysis places a burden on the producers of [ephedra products] to demonstrate a benefit as a precondition of sale," she said, "and that is contrary to Congress's intent."
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