FDA Issues Warning on Herbal 'Ecstasy' Drugs
On April 10, the Food and Drug Administration issued a warning about "herbal ecstasy" over-the-counter supplements, citing some cases of heart attacks, seizures, strokes, and deaths associated with use (Geoffrey Cowley, "Herbal Warning," Newsweek, May 6, 1996, p. 61; Marian Burros and Sarah Jay, "Concern Grows Over Herb That Promises a Legal High," New York Times, April 10, 1996, p. C1).
The products contain the herb ephedra (also known as ma huang), a form of the stimulant ephedrine, and have been marketed to young people and recreational drug users under names such as "Herbal Ecstacy" (sic), "Ultimate Xphoria," and "Cloud 9." They are advertised in High Times magazine and were sold openly at a booth at the Lollapollooza concert in West Virginia in 1995. Ephedrine and its herbal form are commonly found in decongestants. Herbal stimulants, weight loss products, and over-the-counter energy boosters combine ephedrine (or ephedra) with caffeine to "increase energy" or aid in weight loss. The FDA has reports of 15 deaths and 395 lesser incidents related to use of the products.
"The FDA takes seriously the health risks inherent in these products and is currently investigating the production and marketing of ephedrine-containing products marketed as alternatives to illicit street drugs," the warning states. "The agency is committed to taking whatever action is necessary to remove dangerous products from the market."
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which protects vitamins and herbs from most FDA regulation. No FDA approval is required before the vitamins or herbs go on the market, but the agency can pull products it demonstrates are harmful.
The warning was prompted in part by the March 7 death of Peter Schlendorf, 20, who took "Ultimate Xphoria" with some friends while on spring break in Panama City, Florida. The cause of his death was determined to be a combination of ephedrine, pseudoephedrine, phenylpropanolamine, and caffeine, all of which are found in the product.
According to the New York Times, 20 states have proposed limiting sale of products containing ephedrine or ephedra. Florida has already banned herbal ecstasy products. In response, at least one manufacturer is introducing new herbal stimulant blends. Even if the FDA succeeds in forcing ephedra-based stimulants off the market, new blends are sure to replace them. Global Media Corporation in Venice, California, which makes the product "Herbal Ecstacy," will soon introduce a product that substitutes the herb kavakava for ephedra. Ephedra is a stimulant. Kavakava is a depressant.
[A similar "epidemic" of this kind of over-the-counter stimulant abuse occurred in 1979-1981. Ephedrine, pseudoephedrine, caffeine, and phenylpropanolamine were packaged to look like various controlled substance amphetamines and other stimulants. The primary concern at that time was that "legal" stimulants were packaged to look like controlled substances frustrating the prosecution of "drug dealers." A secondary concern was the harm to the drug consumers directly from the stimulants, and the confusion of drug users about the potency of what appeared to be pharmaceutical products. Treatment of overdoses was hindered by confusion about the actual drug ingested. See the hearings before the Subcommittee on Crime of the House Judiciary Committee on "Look Alike Drugs," October 14, 1981, Serial No. 95. (The hearing record provides another example of how some members of Congress are easily confused about drug issues.) --EES]