Herbal Ecstacy under scrutiny

Ravers and other recreational users of ephedrine-based herbal products may soon find local retail shelves empty if the Food and Drug Administration gets its way.
The FDA has ordered six manufacturers and distributors of ephedrine-based products such as Herbal Ecstacy to explain why sales have continued despite FDA warnings of the detrimental effects of these products.

"We put out a letter to manufacturers advising them that it is outside the bounds of permissible law as well as irresponsible to distribute these products considering the possible adverse effects," Arthur Whitmore, director of FDA's press relations in Washington D.C., said

In March, a 19-year-old college student from New York died in Panama City, Fla. during spring break, after ingesting eight tablets of Ultimate Xphoria, a product similar to Herbal Ecstacy. The coroner in Panama City attributed the student's death directly to the intake of Ultimate Xphoria.

Following that incident, New York, Florida and Nebraska banned the sale of ephedrine-based products marketed for recreational purposes.

In response to the death, the FDA issued a "Statement on Street Drugs Containing Botanical Ephedrine," on April 10. The statement informed users of possible risks associated with these products but did not call for their removal.

Whitmore declined to disclose all the names of the six companies that received the letter from the FDA because the information has not been released publicly. He did confirm that Global Media Corp., the manufacturer of Herbal Ecstacy, was one of the compa nies on the list.

Ephedrine is derived from the Chinese herb ma-huang, historically used for therapeutic purposes. High doses of ephedrine can increase heart rates and lead to heart palpitations.

A pamphlet for Herbal Ecstacy lists euphoric stimulation, increased energy levels and tingly sensations among the effects the user will experience.

"It would be preferable if the FDA regulated Herbal Ecstacy or other products that contain ephedrine," said Dr. Marina Bermudez of SF State's Student Health Center.
Bermudez reasons that this substance has killed people who use it in an herbal form an d that it's being used for recreational and not medicinal reasons. She hasn't treated any student on campus for complications caused by ephedrine intake.

Herbal Ecstacy and similar ephedrine-based products are marketed as safe and legal options to the illegal street drug MDMA, commonly referred to as ecstacy.

Herbal Ecstacy and similar products usually come in packages of 10 tablets that sell for about $20. Head shops along Haight Street report slumping sales compared with those of just six months ago.

Haight Street Tobacco Shop and mall owner Rasmi Zeidan said he was selling as much as six packets a week earlier in t he year. Currently sales are down to a single packet per month.

"They're alternatives to elicit street drugs masquerading as safe herbal products," Whitmore said.

In 1994 Congress passed the Dietary Supplement Health and Education Act. The DSHEA removed the burden of approving herbal products from the FDA, thus introducing a host of alternative homeopathic remedies on the market not subject to the rigorous FDA appr oval process, including ephedrine-based products marketed for recreational use.
Although the DSHEA allows the manufacturing of herbal products for health uses, Whitmore said manufacturers of Herbal Ecstacy "took advantage of this legislation."
While it seems likely that ephedrine-based products will be regulated by the FDA, the d etails of that regulation haven't been established.

"Regulatory steps by the end of this year will be made," Whitmore said.

Last week, the FDA assembled an advisory committee to discuss regulation of ephedrine-based products.

"Half of the committee felt we could not set a safe dosage but all agreed that recommended dosages should be far lower than they currently are," Whitmore said.

[ Golden Gater Online September 5, 1996 ]

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