HB LAW (13 The Entheogen Law Reporter 120-122)

The substance gamma-hydroxybutyrate (GHB) has been the subject of numerous recent stories in the popular media. While few would call it an “entheogen,” many have reported euphoria, visual alterations, and subtle psychedelic effects. GHB has found its way into the entheogen-using community. In the last few months, I have received at least a half-dozen communiqués inquiring about GHB’s legal status in the USA. This article will detail the legal history of GHB, some of the past FDA undercover operations centered on GHB, and the substance’s current legal status in the USA. More...

The Substance

GHB is an endogenous neurochemical and metabolite of gammaaminobutyric acid (GABA), which has been identified in the human brain and cerebrospinal fluid.2 GHB was first synthesized in 1961. It is reportedly a safe non-toxic, non-addicting, hypnotic agent that produces objective and subjective normal sleep, except for increasing slow-wave sleep and shortening the REM latency. GHB is currently being successfully used in Canada to treat narcolepsy and cataplexy, and in Europe as an anesthetic adjunct. Tests are also currently underway at the University of Chicago to determine whether GHB might be useful as a muscle-toning agent in older people as well as a sleep aid. Other studies have shown its potential efficacy in treating alcohol withdrawal syndrome.

Testifying in a 1992 GHB case, Dr. Andrew Weil explained that the consensus in the scientific literature is that GHB “is an outstandingly safe pharmacological agent.” When asked, “Is it an hallucinatory drug,” Dr. Weil replied, “Absolutely not.” In further testimony, Dr. Weil stated that GHB “has no resemblance to an hallucinogenic drug . . . It is by chemical definition not a hallucinogenic drug.”3

GHB is easily made in a crude home laboratory (i.e., a kitchen) by mixing proper proportions of gamma butyl lactone (a common oil that can be purchased at chemical supply houses), with either lye or sodium hydroxide. As would be expected, such home-made products are often adulterated and quite commonly have dangerously alkaline pH levels.

Early Legal Status

Throughout the 1980s, GHB was widely sold to body-builders in health-food stores and via fitness magazines. Its promoters claimed (truthfully) that GHB stimulated the release of growth hormone. On November 8, 1990, the FDA issued a press release stating that GHB can cause nausea, vomiting, severe respiratory problems, seizures and coma.4 The warning stated that the FDA had reports from more than 30 people who had become ill after taking GHB. Although this was simply a press release and was never published in the Federal Register, it led many health-food stores to discontinue sales of GHB, and triggered the substance’s transformation from a legitimate, widely-available and generally well manufactured health product, to a gray- and black-market drug. From that point on, with few exceptions, GHB has received nothing but bad press.5

Undercover FDA investigators,
Amino Discounters, and Operation Bigmouth

In conjunction with its 1990 warning, the FDA began investigating the commercial distribution of GHB as an unapproved drug to promote muscle gain and weight loss. In late 1990, the FDA took its first action by raiding Amino Discounters, an Arizona company. Information uncovered during the raid indicated that Amino Discounters had recently sent a one-pound package to a residence in Thousand Oaks, California. Further investigation of the Thousand Oaks residence led agents to obtain a search warrant for the home and inside they found relatively large quantities of GHB. Lawrence Wood, who lived at the home, was arrested.

Despite his arrest, Mr. Wood continued selling GHB. About one month after Wood’s arrest, an undercover FDA investigator succeeded at getting Wood, through Wood’s friend Daniel Duchaine, to mail the investigator several bottles of GHB. The bottles arrived unlabeled. In one conversation with the undercover investigator, Duchaine said that he and Wood sold unlabeled products in order to avoid FDA scrutiny. A raid of Duchaine’s storage locker in the spring of 1991, uncovered a quantity of unlabeled GHB.

On June 18, 1991, Wood and Duchaine were charged with the following federal crimes premised on their distribution of GHB: (1) conspiracy to defraud the FDA by obstructing the FDA’s function of ensuring that “prescription drugs” are safe and effective and dispensed pursuant to a prescription from a practitioner licensed by law to administer such drugs; (2) distributing misbranded GHB in interstate commerce with the intent to defraud; (3) holding misbranded GHB for sale; and (4) distributing GHB without a label stating the manufacturer, distributor, and quantity.

In their defense to the conspiracy charge, Wood and Duchaine argued that GHB was not a prescription drug. The government countered that GHB fell within the meaning of “prescription drug” because it was a drug intended for human use which due to its toxicity or other potentially harmful effect, was not safe for use except under the supervision of a doctor.6 After a jury trial in the federal District Court for the Central District of California, both men were convicted.7

Wood and Duchaine appealed. Among other arguments, they argued that there was insufficient evidence to prove that they knew that GHB was a prescription drug. In an unpublished opinion, the Ninth Circuit reviewed the evidence introduced at the mens’ trial. Acknowledging that there was conflicting evidence of GHB’s prescription status, the Ninth Circuit concluded that under the very deferential standard of reviewing such a matter on appeal, there was sufficient evidence of GHB’s lack of safety when used without a doctor’s supervision to uphold the mens’ convictions.

With regard to the mens’ intent to defraud the FDA, the Ninth Circuit noted that although neither man used fictitious names, there was evidence that both Wood and Duchaine discussed “methods of avoiding detection” and were “careful not to generate or maintain any records of [their] . . dealings.” Most fatal, said the Ninth Circuit, were conversations both men had with the undercover FDA investigator in which they specifically stated that the bottles of GHB were purposely left unlabeled in order to avoid FDA scrutiny. The Ninth Circuit also upheld the convictions for “misbranding” GHB, remarking that “[u]nlabeled drugs are considered misbranded . . . , and misbranded drugs are not supposed to be introduced into interstate commerce.”8

In March 1992, Mark Thierman, the proprietor of Amino Discounters, (the company whose raid led to the above-discussed investigation of Wood and Duchaine) was charged with operating an unregistered drug manufacturing facility and with introducing an unapproved drug into interstate commerce. Like Wood and Duchaine, Thierman ignored the indictment and continued in the GHB business. He set up two new GHB manufacturing facilities, but stopped making claims as to GHB’s effects, simply labeling the bottles “GHB.”

At his trial, Thierman argued that once he began labeling the product as GHB he never sold it as “a drug” (although he admitted that prior to that time he had openly promoted GHB’s drug effects).

While the Ninth Circuit’s opinion is largely irrelevant for our purposes, the court did discuss the question of whether Thierman sold the GHB as a “drug” despite the fact that his new labels made no claims The Ninth Circuit explained that such “intent may be derived or inferred from labeling, promotional material, advertising, or any other relevant source.” The court pointed to evidence that Thierman used GHB with a customer for the purposes of “getting high,” remarking that such evidence served as a relevant source for inferring that Thierman did indeed sell GHB with the intent that it be used as a drug.9

Shortly after Thierman was found guilty, Georgia resident Joseph Saffar pled guilty to one federal felony count of introducing a misbranded drug into interstate commerce.10 Saffar first came to the FDA’s attention when they found his name on a customer list seized from Amino Discounters. Saffar ran a health-food store, called Naturally Good, which sold GHB manufactured by Amino Discounters. In early 1993, an undercover FDA investigator went to Naturally Good and purchased several bottles of GHB after eliciting statements by Saffar that GHB would help a person “bulk up” and “get high.”

Saffar was sentenced to 21 months in federal prison and a $30,000 fine. Four months after Saffar’s conviction, Georgia became the first state, on March 4, 1994, to make GHB a Schedule I controlled substance.11

Through “Operation Big Mouth” a joint effort by US Customs, the FDA, and other government agencies out to catch illicit drug traffickers, the FDA was led to Frank Zenker and Lance Griffin. Operation Big Mouth took its name from it’s central technique of coercing arrestees to identify other “traffickers” and assist the FDA in making purchases of drugs.

Zenker and Griffin operated a company by the name of Omniopathy Products through which they sold GHB as bulk powder and in capsule form. In late 1991, FDA investigators quietly searched garbage left outside the offices of Omniopathy, finding invoices and other documents showing that Omniopathy was selling GHB as a product called “Oxy-Sleep.”

Investigators found that Oxy-Sleep’s label falsely stated that the drug was glutathione and also failed to give adequate directions for use and warnings. Undercover investigators posed as interested buyers, called the company’s toll-free line and ordered Oxy-Sleep. Tests of the product were positive for GHB. In February 1992, armed with a search warrant, the FDA raided Omniopathy seizing computers, letters, promotional material, and over 600 kilos of GHB. On October 27, 1994, Zenker was sentenced to a 16-month federal term for conspiring to illegally distribute GHB. Griffin was sentenced to two years, nine months.12

Present Legal Status of GHB

Since November 8, 1990, GHB has been under investigational new drug status with the FDA. The drug is not approved for marketing in the United States. In 1992, the FDA issued an “Automatic Detention Alert” for several substances including GHB. The alert instructed Customs officials to “[a]utomatically detain all shipments of finished dosage forms (both commercial and personal) of [GHB].” As far as I know, this is still in effect today. Customs agents continue to seize imported shipments of GHB when they find them.

ADDENDUM: Effective _____ GHB is a Schedule I controlled substance under federal law. 

ADDENDUM: GHB is a controlled substance in many states. Here's a list.

 

Notes

 

1 GHB is also known as 4-hydroxy butyrate, sodium oxybate, and by such “street names” as: “Liquid X,” “Scoop,” “Grievous Bodily Harm,” “Easy Lay,” “Gook,” “Gamma 10,” and “G.”

2 P. Vayer, P. Mandel, and M. Maitre, “Gamma-hydroxybutyrate, a possible neurotransmitter,” Life Sci., 41: 1547-1557 (1987).

3 United States v. Wood (9th Cir. 1995) 57 F.3d 733.

4 Food and Drug Administration, “Gamma hydroxybutyric acid” (Press Release P90-53), Rockville, Md, Nov. 8, 1990; “FDA Caution on Drug” Newsday, Friday, November 9, 1990.

5 GHB gained notoriety with the Halloween 1993 death of actor River Phoenix. Although rumors circulated that he ingested GHB earlier in the night, the autopsy released on November 1 was inconclusive as to the cause of death. (S. Hubler, S. Hochman,“’Designer Drug’ Enters Hollywood’s Fastlane,” Los Angeles Times, Nov. 3, 1993.) According to a recent article in the Village Voice, GHB is widely used by models and is currently the popular drug in the club scene. (G. Trebay, “The Model Drug: GHB Puts a Happy Face on Fashion Week” Village Voice, November 5, 1996.)

Most recently, GHB has been labeled as a “date-rape” drug along with Rohypnol (aka flunitrazepam, “roofies,” “Mexican valium,” “roachies.” (See, “What the Date Rape Drugs Do.” Los Angeles Times, Tuesday, October 8, 1996.)

In 1996, two Florida men were accused of using GHB to facilitate the rape of a woman they met in a Boca Raton club. (T. Borden, “Officials Warn of Roofie-type Drug Use of ‘Grievous Bodily Harm’ Tied to Boca Rape Case,” Sun Sentinel Ft. Lauderdale, Thursday, June 27, 1996. An article in the same paper by the same writer later called GHB “the latest drug in the arsenal of rapists.” (T. Bordon, “Judge Sets Bail Despite Pleas In New ‘Date Rape Drug’ Case,” Sun Sentinel Ft. Lauderdale, Friday, June, 7, 1996.)

The only positive news report I have found concerning GHB was broadcast on the December 10, 1996 ABC World News segment called “Solutions.” The report focused on “gamma hydroxybutyrate” (never once calling it GHB), as a potentially miraculous new drug for treating insomnia and other sleep disorders. The researchers interviewed in the segment noted gamma hydroxybutyrate’s potential as an anti-aging drug that increases the body’s natural secretion of growth hormone and, thereby, helps tone muscles and tissues.

 

6 21 USC 353(b)(1)(B).

7 The details of this trial can be found in the unpublished disposition of the Ninth Circuit (United States v. Wood & Duchaine (9th Cir. 1993) 8 F.3d 33, 1993 WL 425948; see also, the published Ninth Circuit opinion United States v. Wood, cited in footnote 3.)

8 See footnote 3.

9 Unpublished disposition United States v. Thierman (9th Cir. 1996) 76 F.3d 390.

10 D. Stehlin, “Georgia Man Arrested in GHB Seizure” FDA Consumer, Saturday, October 1, 1994, Vol. 28, No. 8.

11 Georgia Code 16-13-25.

12 P. Kurtzweil, “Drug Trafficker Jailed,” FDA Consumer, Friday, September 1, 1995, Vol. 29, No. 7.

17 J.E. Dyer, “Gamma-Hydroxybutyrate: A health-food product producing coma and seizure-like activity,” Am J. Emerg. Med., July 1991; 9 (4): 321-324.

18 “Multistate Outbreak of Poisonings Associated With Illicit Use of Gamma Hydroxy Butyrate,” Journal of the American Medical Association, January 23/30, 1991, Vol. 265, No. 4.