FDA overstepped bounds with ban on ephedra

Freedom Newspapers

Sometimes the Nanny State goes too far, even for federal courts. That happened earlier this month in a case involving the Food and Drug Administration’s 2004 ban on the sale of the herb ephedra, commonly used as a diet aid. The ban came after the deaths of more than 80 people, most notably Baltimore Orioles pitcher Steve Bechler in 2003.

However, ephedra’s defenders said it was used safely by as many as 12 million Americans and those who died from it exceeded the recommended dosage.

U.S. District Judge Tena Campbell ruled April 14 that the FDA had failed to prove that ephedra was dangerous in low doses — those of 10 milligrams or lower. And she ruled that the FDA “lacked the authority to ban the substance without such proof,” in the New York Times’ summary.

Judge Campbell relied on federal law, which makes a distinction between drugs and supplements. Pharmaceutical companies must prove drugs safe before they can be sold; but supplements are treated as a food — that is, they are presumed innocent until proven harmful.

“(If) food producers were required to show a benefit as a precondition to sale, the sale of foods such as potato chips might be prohibited,” Judge Campbell wrote in her decision.

We would add that the FDA’s ban on ephedra was not complete. It only banned it as a supplement, commonly known as the Chinese herb ma huang. But the FDA never banned ephedra in some over-the-counter medications. For example, Primatene contains ephedrine, the stimulant in ephedra.

The crux of the problem is that the FDA is in a “deadly over-regulation mode,” said Sam Kazman, general counsel for the Competitive Enterprise Institute, a free-market think tank.

That means the FDA is so worried about getting into trouble by approving something that turns out to be harmful (such as the infamous thalidomide) that it also is withholding things that could help people. He pointed to the FDA’s recent findings of the potential deadly side-effects of some arthritis drugs. Celebrex, for example, remains on the market with extra warnings.

But Bextra was pulled from the market earlier this month. However, Kazman pointed out that for some people only Bextra works. Provided they are warned of the side-effects, he said, it should be a patient’s own choice whether to take the drug.

“Because of all the publicity on ephedra, people are on notice” about its risks, he noted. “When it’s on the market, people have a choice.”

We urge the FDA not to appeal this case. If it does, higher federal courts should uphold Judge Campbell’s opinion.
And Congress should not get involved with new legislation restricting the right of Americans to use ephedra or any other supplements.