Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: TUESDAY, September 5, 1995 TAG: 9509070006 SECTION: EXTRA PAGE: 3 EDITION: METRO SOURCE: PATTY SHILLINGTON KNIGHT-RIDDER NEWSPAPERS DATELINE: MIAMI LENGTH: Long
Some of the eager customers want to dance till dawn. Others hope for soaring sex. Jeff Cady, a 21-year-old Miami office administrator, is looking for ``hypersensitivity.''
Whatever buzz Cady gets will be legal, born of herbs used for centuries in ceremonies or as medicine. Intended to make users feel euphoric, energetic and sexually aroused, with no nasty hangover, Herbal Ecstacy - its name is purposely misspelled - and similar products are being marketed as a safe alternative to illicit, unpredictable street drugs.
So far, Herbal Ecstacy has drawn few, if any, serious complaints from the people who have purchased nearly 10 million doses since its debut last year. But products with some of the same ingredients have been linked to several deaths, heart attacks, strokes and other serious side effects.
Lisa Foster, 23, of Miami, took a dose of Herbal Ecstacy ``just for fun'' on a recent night out with friends. ``Lights were a little brighter,'' she said. ``I felt speedy. It felt good. I was conscious I had taken something, but I wasn't out of control.''
Foster, like other users, assumes the product is safe because it's legal.
To critics of this new high, safety is a big question mark.
Because these products are made not as drugs but ``dietary supplements,'' they're largely untested by government regulators. And their exact formulas - how much of each herb is present - are not revealed.
``With dietary supplements, basically there's no premarket approval system,'' says Brad Stone, a spokesman for the U.S. Food and Drug Administration. ``It's only if we can somehow determine there's a problem and show there's a problem that we can take action against it.'' Global World Media Corp., the Venice, Calif.-based maker of Herbal Ecstacy and several other herbal pills, says its products are ``designed to be as natural and safe and effective as possible.''
``It's not harmless candy,'' says Robert Kessler, the firm's vice president of U.S. retail sales. ``It's not for children. It's not appropriate for everyone. But in the realm of acceptable risks, undeniably it's a very safe product.''
There is no doubt that herbs like Chinese ma huang, a source of the stimulant ephedrine, can be dangerous in high doses, if not used according to directions, or when mixed with potent sources of caffeine, such as cola nut and guarana. Each of those three herbs is found in Herbal Ecstacy - in what Kessler insists are safe doses.
Herbal Ecstacy, Kessler says, is less than 5 percent caffeine and less than 2 percent ephedra, the Chinese plant rich in ephedrine. He says adverse reactions appear most commonly when people take more than the recommended dosage.
``The product contains stimulating properties, yes,'' Kessler says. ``It would wear the body down if you overuse it.'' Dr. Pepi Granat, a Miami physician for 24 years, issues an ominous warning about products like Herbal Ecstacy.
``Anything strong enough to make you high is also strong enough to cause cardiac arrhythmia and I'd be extremely worried about it,'' says Granat, a former member of the American Academy of Family Physicians' National Committee on Drugs and Devices. She says users are ``taking their life in their hands,'' especially because there's no way of knowing exactly what's in the pills.
In the past year and a half, the FDA has logged more than 100 reports of adverse reactions to Nature's Nutrition Formula One, a weight-loss dietary supplement that, like Herbal Ecstacy, contained both ma huang and cola nut. Reactions ranged from life-threatening - heart attack, stroke, irregular heartbeat, seizures and psychosis - to minor, temporary conditions such as dizziness, headache and gastrointestinal distress.
In February, the FDA warned consumers not to buy or use Formula One after the manufacturer failed to recall the product. The company has since reformulated the supplement without cola nut, though the older product could still be on the shelves in stores and consumers' homes.
In South Florida early this year, Metro-Dade Sgt. Charles Nanney sued the manufacturer of an herbal nutritional supplement called Ma Huang, which contains the ephedrine-rich herb. Nanney claims the product caused him to have a stroke last year at age 29. The suit is pending in federal court.
The FDA's Stone says his agency will continue monitoring products with ma huang and urges consumers to report side effects. But he added that not all products containing ma huang and cola nut are necessarily dangerous.
``The amounts of cola nut and ma huang may be dramatically different in other products than they are in that particular form of Formula One,'' he says.
Kessler, who won't reveal Herbal Ecstacy's exact formula, points out that virtually any product - from aspirin to alcohol to automobiles - can be dangerous if used irresponsibly.
``The whole reason that we started this company was as a response to the abuse of illegal drugs and chemicals sold on the street,'' he says.
Don Vernon, owner of Uncle Sam's three music stores in South Florida, says he takes Herbal Ecstacy ``all the time.'' He was the first South Florida retailer to carry the pills; 100 retail outlets, mostly health-food stores, now sell Herbal Ecstacy statewide, says Barbara Busch, CEO of operations for Miami Beach-based Herbal Alternatives USA, the regional distributor for Herbal Ecstacy.
Kessler says he's grown accustomed to criticism but pays more attention to the growth of sales and lack of consumer complaints. ``We're attacked by people on the right who say we're enticing people to do drugs and we're attacked by the left-wing herbalists who think we're abusing their sacred plant,'' Kessler says.
We-B-Joys, a novelty and head shop, has been selling Herbal Ecstacy for about two months. ``It's going gangbusters,'' says owner Bill McMahon, declining to give sales figures.
McMahon sees the herbal-drug phenomenon as the latest twist in the age-old pursuit of psychic escape.
``I personally think it's all a crock,'' says McMahon. ``But if it works for you, do it. I'm a Ben and Jerry's guy myself.''
by CNB