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16.

GHB FDCA Violations

Civil Resources Manual 16, GHB was originally developed as an anesthetic in 1960, but significant side effects and lack of analgesia limited its use. For a period of years it was legally available only under FDA- approved clinical studies for narcolepsy, schizophrenia, and other serious disorders. It was also banned as a dangerous or listed drug by a few states, and remains so. Its federal status, however, has undergone significant changes in recent years.

On February 18, 2000, the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 1999 was signed into law. The Act declared the abuse of GHB to be an imminent hazard to public safety and directed the DEA to schedule the drug within sixty days. In addition, the Act made GBL (an ingredient in GHB) a List I chemical. On March 13, 2000, DEA scheduled GHB as a Schedule I controlled substance.

On the other hand, the FDA in 2002 approved GHB, sold under the brand name Xyrem, to treat cataplexy, a rare form of narcolepsy characterized by excessive daytime sleepiness and loss of muscle control. Xyrem's distribution is carefully controlled, with prescriptions dispensed via a single mail-order pharmacy. GHB is otherwise not legally available in the United States.

GHB entered the underground drug market in 1990 as a substitute to anabolic steroids and has become extremely popular for its psychoactive properties. It is available as a white powder or a clear liquid, and is usually sold in unlabeled containers without directions or warnings for use. The underground drug is typically made in clandestine labs by heating gamma butyrolactone and sodium hydroxide. Consumption of GHB, particularly in combination with alcohol and other central nervous system depressants, is extremely dangerous and has resulted in coma, sudden onset of sleep, seizures, extreme vomiting, and death.

GHB is considered a "drug" under the FDCA because the claims associated with it (i.e., causing the release of a growth hormone, inducing sleep, having anabolic and psychoactive properties, and acting as a sexual stimulant) meet the drug definition in 21 U.S.C. § 321(g)(1)(C).

GHB sold in the black market is considered a "misbranded" drug because of the deficiencies in its labeling under all circumstances in which it has to date been distributed. See, e.g., 21 U.S.C. § 352(b)(1) (label does not contain the name and place of business of the manufacturer, packer, or distributor), 352(b)(2) (label does not contain an accurate statement of the quantity of the contents), 352(e) (label does not bear the established name of the drug), 352(f) (labeling does not bear adequate directions and warnings for use). It is unlikely that adequate directions and warnings can be written for GHB, so GHB will remain "misbranded" in the black market. Be aware, however, that expert testimony will be required to establish the inadequacy of the directions and warnings used in the "labeling" of GHB in a particular case.

It is a violation of the FDCA to: (1) distribute misbranded GHB in interstate commerce, 21 U.S.C. § 331(a); (2) receive an ingredient in interstate commerce and use it to manufacture misbranded GHB, while holding it for sale, 21 U.S.C. § 331(k); (3) receive misbranded GHB from interstate commerce and proffer it for sale, 21 U.S.C. § 331(c); or (4) manufacture GHB for commercial distribution without registering to do so, 21 U.S.C. §§ 360 and 331(p). These offenses are felonious if done with the intent to defraud either the consumers of the drug or state or federal agencies regulating the drug.

[updated November 2002] [cited in Civil Resource Manual 15]