Judge Strikes Down Ban on Ephedrine

[I am Roboto]

Judge Stikes Down Ban on Ephedrine
MSNBC.com - The Associated Press
April 2005

SALT LAKE CITY - A federal judge Thursday struck down the FDA ban on ephedra, the once-popular weight-loss aid that was yanked from the market after it was linked to dozens of deaths — including that of Baltimore Orioles pitching prospect Steve Bechler.

The judge ruled in favor of a Utah supplement company that challenged the Food and Drug Administration’s ban. Nutraceutical claimed that ephedra “has been safely consumed” for hundreds of years, and that ephedra was wrongly being regulated by the FDA as a drug and not a food.

Judge Tena Campbell agreed, saying federal law places more restrictive rules on the FDA in determining whether to ban foods as opposed to drugs. The judge said the law requires the FDA to prove that a dietary supplement is harmful, rather than having the manufacturer prove it is safe, as is required with drugs.

Nutraceutical President Bruce Hough said the lawsuit had little to do with ephedra and more to do with forcing the FDA to follow the rules Congress set down for it.

He said Nutraceutical interprets the ruling to mean that the company is allowed to start selling ephedra supplements again, but added that it is too soon to say whether it will put the products back on the market.

“This is a great affirmation for the system, that the court goes back and says, 'This is Congress’ intent,' and follow it,” he said.

FDA spokeswoman Kimberly Rawlings said the agency is “evaluating the decision.”

Ephedra, the herbal form of the stimulant ephedrine, was used as a weight-loss supplement by millions of Americans. Reports of links to illness and sudden death resulted in a heated debate over its safety and led to the government ban on products containing ephedra. Ephedra, which is also known by its Chinese name, ma huang, has been used as a medicinal herb for thousands of years in India and China to treat asthma, bronchitis and coughs. In recent years, it was widely promoted in the United States as an appetite suppressant and weight-loss aid in over-the-counter products, such as Xenadrine. An estimated 12 million Americans used the supplement in 1999, according to researchers. The two main chemicals in ephedra, ephedrine and pseudoephedrine, are stimulants that lead to the constriction of blood vessels. In low doses, they act as decongestants, but in higher doses, they can raise blood pressure. The stimulant effect contributes to the herb’s effectiveness as an appetite suppressant but can lead to severe cardiovascular reactions. Consumption of ephedra can also result in a false-positive for amphetamines in urine tests. A variety of studies have linked ephedra to cardiovascular problems, including high blood pressure, palpitations and heart attacks. Strokes, seizures, psychosis, insomnia and heatstroke have also been reported. The supplement has been conclusively linked to cases of healthy adults suddenly falling ill or even dying after taking it. People with high blood pressure, heart disease, anxiety, glaucoma, enlarged prostate or hyperthyroidism are particularly at risk. Researchers studying ephedra at the University of California, San Francisco, reported that people who take ephedra products are 200 times more likely to suffer a complication than are users of other herbal supplements. Ephedra is responsible for 64 percent of all adverse reactions from the use of herbal supplements, although ephedra products make up less than 1 percent of all herbal supplements sold in the United States, researchers say. Public Citizen, a consumer advocacy group, says more than 150 deaths since 1995 have been linked to ephedra.

Bechler was 23 when he died after a spring training workout on Feb. 17, 2003, sent his body temperature to 108 degrees.

The medical examiner who performed the autopsy said the pitcher had a history of borderline high blood pressure and an abnormal liver. The medical examiner also said that ephedrine — the active substance in the plant ephedra — played a major role in the pitcher’s death.

In an effort to quickly shed the weight he gained during the offseason, Bechler took over-the-counter diet pills containing ephedra. The drug had been banned by the NCAA, NFL and International Olympic Committee, but not by Major League Baseball.

Supplements that included ephedra were once widely used for weight loss and bodybuilding, with industry groups claiming at least 12 million users. The amphetamine-like stimulant, which speeds the heart rate and constricts blood vessels, has been linked to 155 deaths. The federal government banned it one year ago.

Campbell’s ruling sends the matter back to the FDA “for further rulemaking consistent with the court’s opinion” and keeps the agency from enforcement action against the companies.

[TripperFan]

Well this judge can do what he likes, but all I know is from personal experience with the stuff and it AIN'T good!

My husband and I were both taking Thermadrine a few years back when we were body building. Both of us noticed many side effects from it even though we were aware of the dangers. It gave us the shakes, headaches, heart palipitations amongst others.
Ma huang might be fine on its own, but the trouble came when it was combined with caffiene and sometimes codiene to give the effect required for body building. Its the stack that's dangerous. Without that combination, I noticed nothing - it didn't even work for me as an antihistamine.
He can strike down the ban, but I hope that he can deal with the guilt if and when people die or being invalids because of using it.
Just kills me how people think "natural supplements" aren't harmful. Why wouldn't they be - just like the first guy who tried mushrooms. Might have come across a few and tasted good and didn't hurt him. Then he found a type that got him high. Then he found the type that can kill - and that's the last anyone heard from him!!