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]