June 2, 1997

FDA proposes crackdown on ephedrine-laced dietary supplements

BY LAURAN NEERGAARD
Associated Press Writer

WASHINGTON (AP) -- After at least 17 deaths and 800 illnesses linked to ephedrine-laced dietary supplements, the government said Monday it will crack down on the pills, tablets and teas that promise to help people lose weight, build muscle and feel more energetic.

The Food and Drug Administration plans to dramatically cut the dose of the herbal stimulant that can be put into any dietary supplement, and to ban the marketing of ephedrine-containing products as weight-loss or bodybuilding agents.

In addition, many of the supplements would bear warnings that too much of the product can kill, the FDA announced.

No one with heart disease, high blood pressure or neurologic disorders should use ephedrine supplements because the amphetamine-like stimulant can cause heart attack, stroke, seizure or death, the FDA said.

But the FDA found case after case of previously healthy young people who were injured after taking ephedrine supplements, so it proposed new regulations Monday that would affect how dozens of brands are manufactured and marketed.

"Consumers should be aware that just because a product is labeled `natural' or from an herbal source, it is not guaranteed to be safe," said Dr. Michael Friedman, FDA's acting commissioner.

The FDA didn't go as far as Florida and New York, which banned ephedrine supplements after pills with such names as Herbal Ecstacy and Ultimate Xphoria promised a "natural high." The bans came when a 20-year-old college student died after taking Ultimate Xphoria last year.

The FDA already had moved to stop companies from promoting supplements as alternatives to illegal drugs. But Monday's proposals cover traditional dietary supplements sold in health-food shops, convenience stores and gyms.

"The industry recognizes that the safety issues surrounding ephedra need to be effectively addressed," acknowledged the Council for Responsible Nutrition. However, the industry group said some of the proposals go beyond its own recommendations and will need further evaluation.

Ephedrine has a long history of safety, countered Nutri/System Inc., the weight-loss chain that sells "herbal phen-fen," a supplement alternative to the diet pill phen-fen. Nutri/System's pill, to be taken daily, contains 40 milligrams of ephedrine, above the 24-milligram dose the FDA set Monday as safe.

"Our clients like it. We have had no problems," said Nutri/System spokesman Joseph DiBartolomeo.

But to back its case, the FDA detailed how a previously healthy 23-year-old Boston college student used an ephedrine-containing "protein drink" for bodybuilding for two years. One day he dropped dead because, the coroner ruled, the drink killed portions of his heart.

A 35-year-old woman had a heart attack after using ephedrine-containing pills for about 11 days, and a 35-year-old man took just five capsules before a workout and had a heart attack, the FDA added.

Ephedrine also sells under the names Ma huang, Chinese ephedra and epitonin. It is a compound extracted from plants and used for centuries by Chinese practitioners as a medicine.

Long controversial, ephedrine is a central ingredient in the illegal drug methamphetamine or speed. The FDA does allow controlled, pure doses in certain medicines that treat asthma.

But a 1994 law forbids the FDA to control dietary supplements unless a particular one proves dangerous. Monday, the FDA called ephedrine supplements dangerous, and proposed:

• Banning supplements with more than 8 milligrams of ephedrine or related alkaloids per serving, and setting the maximum daily dose at 24 milligrams. An FDA survey last year uncovered some supplements that called for users to ingest up to 109 milligrams in a single sitting.

• Prohibiting use of ephedrine products for more than seven days. That would essentially ban ephedrine weight-loss or bodybuilding supplements, because getting those purported health effects requires weeks of use.

• Requiring many supplements to bear the warning: "Taking more than the recommended serving may result in heart attack, stroke, seizure or death."

• Banning caffeine or other stimulants in combination with ephedrine.

The proposal is open for public comment through Aug. 18, when the FDA will develop a final regulation.