Pick-Me-Up Feeling Put Down by the FDA

The makers of Herbal Ecstacy have a message for the U.S. Food and Drug Administration: “Thanks.”

The FDA warned the public last week to avoid Herbal Ecstacy and similar “herbal alternative” supplements. “We’ve probably seen a 25% to 30% jump in sales” since then, says Sean S. Shayan, the young, confident owner of Global World Media Corp., maker of Herbal.

The FDA’s concern over Herbal’s active ingredient, ephedrine, has put the Venice corporation in the spotlight. Its flashy marketing and successful sales (it is the No. 1 seller of such supplements, moving 15 million units since 1991, Shayan says) have inspired government agencies to question allowing sales of ephedrine to go unfettered.

The FDA says herbal ephedrine--sold largely to teens and twentysomethings as a pick-me-up--can cause shortness of breath, heart attacks, even death. The agency is especially concerned about ephedrine products that contain caffeine, as most Herbal Ecstacy does, because the mixture is more potent. While the FDA is considering requiring warning labels and the U.S. Drug Enforcement Administration is pondering prohibiting over-the-counter sales, Global, in turn, is saying it might sue the FDA.

“They’re trying to restrict our trade and they’re being slanderous in doing so,” says Shayan, who reports that he’s 20 years old. He says the company has never been linked to a death, a serious health complaint or even a lawsuit (though a disgruntled distributor is suing, and Global is counter-suing).

Yet, at the same time, Shayan says Global is reformulating its products and has begun taking ephedrine out in favor of a relaxing root extract called kava that has long been used for a ritual drink in Indonesia and elsewhere in the South Pacific.

Shayan didn’t invent ephedrine, a longtime stimulant used to help asthmatics breathe better. But he seems glad to defend it. He is a fast-talking, barefoot-walking, New Age businessman. (He calls himself a “partner and spokesman” for the firm, but state records list him as sole proprietor.) Global’s marketing ranges from the New Age, rave-inspired messages stamped on its pyramid boxes (“Learn to love”) to the name of its Herbal Ecstacy parent company (an 800 number consumers can use to order the product directly from Global).

The company has an airy, geometrical office in Venice, 500 workers worldwide and produces its product domestically, Shayan says. It sells its supplements--Herbal Ecstacy, Nexus (also containing kava) and Magic Mushrooms (a non-psychoactive mixture)--through mail-order ads in the back of weeklies and magazines such as Penthouse, High Times and New York’s Paper for about $15 for a box of 10. The products are also often found at all-night dance parties, concerts such as Lollapalooza and even the clothing store Urban Outfitters for as much as $32.99 a box. The company even sells T-shirts and techno CDs with the Ecstacy trade name.

Shayan, a Tehran native, won’t say how much his company makes or who his “partners” are. And when you ask him how the company started, he spins a tale of an Amazon brainstorming retreat in 1988 (that would have made him 12 at the time), though others in the company have said the product was inspired by bad reactions in the L.A. club scene to the street drug ecstasy.

Herbal Ecstacy’s early growth, in fact, was largely attributable to robust marketing--that the product is just like the street drug, a psychedelic stimulant made popular in dance clubs and outlawed in 1985. “The ephedrine buzz is very similar to a caffeine buzz,” says Chris Simunek, an editor at High Times magazine. “It’s not like ecstasy.”

“When we first came out about three years ago, we were doing some catch phrase gimmicks,” Shayan admits. “But as soon as the FDA said, ‘Hey, you can’t say this, this and this,’ we took it off.”

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Three years later, the FDA still has a problem with Herbal Ecstacy and its marketplace brethren (such as Ultimate Xphoria, made by Alternative Health Research Inc. of Tempe, Ariz., which had “no comment”), simply by virtue of their trade names, which officials say falsely conjure street-drug effects. The herbal alternatives also often give conflicting dosage advice--sometimes suggesting eating one pill, sometimes saying it’s OK to take a whole pack of 10 in a day’s time (which is up to 40 times the single dosage of less controversial over-the-counter ephedrine products).

Yet Shayan says products such as his are being unfairly singled out.

Herbal alternatives are, by far, not the only products that peddle ephedrine for uses other than its true legal calling, as a bronchodilator--a tool for better breathing.

MaxAlert, Mini Thins and Nature’s Nutrition Formula One are but a few of the supplements that promise to keep you alert and make you thin. Sudafed, NyQuil and several other cold products contain a close cousin to ephedrine, psuedoephedrine. In fact, the FDA acknowledges that the evidence it presented against the herbal alternatives--15 deaths and 400 health complaints--mainly apply to these other ephedrine and psuedoephedrine products.

Many of these have long been marketed at convenience stores, drug stores and truck stops. Kids have used them for years to boost athletic prowess and to get a caffeine-like buzz. “It’s going to be hard to regulate ephedrine because the pharmaceutical industry depends on its business,” says Alexander T. Shulgin, a former Dow Chemical pharmacologist-turned-drug culture guru.

The FDA, Shayan contends, is targeting small, herbal-based products like Global’s instead of going after larger, more powerful pharmaceutical companies because it grabs headlines without irritating big business. Indeed, the FDA often refers to herbal ephedrine as a “street drug” but doesn’t do the same in regard to pharmaceutical ephedrine. “If we go out of business today,” Shayan says, “kids are still going to be able to do MaxAlert.”

The FDA singled out herbal alternatives because of their marketing, officials respond. Consumers are more likely to use them “for recreational use,” says an FDA official. “Consumers may be inclined to take them in greater quantities, and these products are targeted to a younger population.”

Last month, a Long Island youth, 20-year-old Peter Schlendorf, died hours after he took a double dose of Ultimate Xphoria while on spring break in Florida, authorities say. The medical examiner’s office for Panama City, Fla., released an autopsy Wednesday that attributed Schlendorf’s death to the heart-pumping mixture of ephedrine and caffeine found in Ultimate Xphoria. “These things are stimulants and they have an adverse effect on the heart and central nervous system,” says Medical Examiner Bob Burch. “He just shut down.”

In response to Schlendorf’s death, his native county of Nassau, N.Y., has moved to ban all ephedrine products. The state of Ohio has already banned the drug and Iowa is moving to do the same.

The FDA is also weighing whether ephedrine is safe for the American marketplace. “If we find these products constitute a threat to public health, we’ll take appropriate steps to remove them from the market,” says the FDA official, who asked not to be named.

The DEA also has its eye on ephedrine because it is a chemical often cooked up in clandestine labs to make methamphetamine, or speed. The administration has discussed outlawing the substance--which would likely make it available only as a prescription drug. “It’s been discussed,” says a DEA deputy director.