Prom night incident leads to GHB prosecutions - gamma hydroxybutyrate

FDA Consumer, June, 1991 by Dixie Farley

Enforcement

FDA's enforcement strategy to stop the illegal marketing of GHB includes public education as well as requests to offending firms to recall their products. The agency is warning these firms that GHB products are subject to seizure and that other court actions may be taken against the distributors.

"GHB is being marketed to many of the same people who bought anabolic steroids," says FDA attorney Michael Petty. "It's been claimed to release large amounts of 'natural' human growth hormone during sleep to obtain the same effects as anabolic steroids, to build muscle and reduce fat. Some people have attempted to us it as a sleep aid or a psychedelic," he says.

Classified as controlled substances under the Anabolic Steroid Control Act of 1990, anabolic steroids now are subject to strict regulation by the Drug Enforcement Administration. Petty says some promoters are trying to fill the anabolic steroid sales vacuum created by that tightening legislation, which became effective in February 1991. The defendants in the March indictments are the first known examples, he says, adding:

"Perhaps those who market GHB think that they can create a false appearance of legality or that we're not going to enforce the law. What they should realize is that we're going after everything illegal in the anabolic steroid milieu. We're going to be very aggressive."

In the United States, legal use of GHB is limited to investigational use under FDA-approved clinical trials, which currently are testing its safety and effectiveness as a treatment for narcolepsy, a rare sleeping sickness.

The indictment against Amino Discounters, Ltd., Thierman, Cano, and Hilton was filed in the U.S. District Court for the District of Arizona on March 6, 1991. It charges the firm, Thierman and Cano with three counts and Hilton with two counts of operating an unregistered drug firm, and charges all four defendants with six counts of selling misbranded drugs in interstate commerce and one count of making misbranded drugs.

The civil fraud case was filed against the firm, Thieirman, and Cano on March 7 in the district court in Tucson.

Also on March 7, Thierman was further charged by a Pima County grand jury in Tucson on four counts of illegally bringing prescription drugs (anabolic steroids) into Arizona.

If convicted on all counts, Amino Discounters faces up to $5 million in fines, Thierman and Cano each face up to 30 years in jail and $2.5 million in fines, and Hilton faces up to 27 years in jail and $3,250,000 in fines.

Byrd and Block were indicted March 8 in the U.S. District Court for the Northern District of California. Besides charges of promoting, selling and shipping GHB, they face one count of distributing drugs with false and misleading labels because the name and address on their label, "Biosky Research Group, San Francisco, California 94104," was fictitious. Such bogus labeling information makes it difficult, if not impossible, to contact a drug distributor if a product recall becomes necessary, as was the case with GHB. If convicted on all counts, Byrd and Block each face up to 18 years imprisonment and $1.5 million in fines.