GHB Probation Letter
I. BACKGROUND INFORMATION FOR SUBMISSION TO PROBATION OFFICE
To ensure that every human drug is safe and effective, Congress
established a comprehensive scheme for the regulation of such drugs through
the FDCA, 21 U.S.C. § 301 et seq. Under the FDCA, 21
U.S.C. § 321(g), a "drug" is any of the following: (A) articles
recognized in the official United States Pharmacopoeia, official Homeopathic
Pharmacopoeia of the United States, or official National formulary, or any
supplement to any of them; (B) articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man or other animals;
(C) articles (other than food) intended to affect the structure or any
function of the body of man or other animals; and (D) articles intended for
use as a component of any article specified above.
- Background Information Concerning The Statutory
Framework For The Regulation Of Human Drugs
The "intended use" of an article, for purposes of determining whether it
is a "drug," can be determined by claims made on the label, accompanying
labeling, promotional material, advertising, oral representations made about
the product, and information from any other source which discloses intended
use. 21 C.F.R. § 201.128; United States v. Storage Spaces Designated
Nos. 8 and 49, 777 F.2d 1363 (9th Cir. 1985), cert. denied,
479 U.S. 1086 (1986); National Nutritional Foods Association v.
Mathews, 557 F.2d 325 (2d Cir. 1977); National Nutritional Foods
Association v. Food and Drug Administration, 504 F.2d 761 (2d Cir. 1974),
cert. denied, 420 U.S. 946 (1975); United States v. An
Article ... Consisting of 216 Cartoned Bottles, More or Less ... Sudden
Change, 409 F.2d 734, 739 (2d Cir. 1969).
The core of the Act's regulatory scheme for drugs intended for use in
humans is its requirement that all "new drugs," 21 U.S.C. § 321(p), be
approved by the FDA as safe and effective prior to marketing.[FN1] The
marketing of a new drug without preapproval from the FDA violates the FDCA.
21 U.S.C. §§ 355 and 331(d).
FN1. "New drug" is defined in Title 21, United States Code, Section
321(p), to be "[a]ny drug . . . the composition of which is such that
such drug is not generally recognized, among experts qualified by
scientific training and experience to evaluate the safety and
effectiveness of drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the labeling
In addition to the premarket approval requirements for new drugs, the Act
requires that all drugs be properly labeled so as to assure their safe and
effective use. This means that all drugs must have adequate directions for
use so that the physician is able to dispense the drug for the appropriate
conditions and in the proper manner, dose, frequency, and duration and the
customer is able to use the drug in a safe and effective manner. "Adequate
directions for use" means directions under which the laymen can use a drug
safely and for the purposes for which it is intended, 21 C.F.R. § 201.5.
Drugs that lack such directions are deemed to be misbranded. 21 U.S.C. §
352(f)(1). Adequate directions for use can not be written for unapproved new
drugs because such drugs have not been shown to be safe and effective for any
The law also requires that a drug contain the true name and place of
business of the manufacturer, packer, and distributor, 21 U.S.C. §
352(b)(1), an accurate statement of the quantity of the contents in terms of
weight, measure, and numerical count, 21 U.S.C. § 352(b)(2), and/or the
established name of the drug, Title 21 U.S.C. § 352(e). These labeling
requirements are necessary for the safe use of the drug.
The FDCA also requires that information on the label be in English so as
to render it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use. The label or labeling is misbranded
if it is in a foreign language. 21 U.S.C. § 352(c).
The FDCA also requires that all individuals involved in manufacturing
drugs for commercial distribution register their facility with the FDA. 21
U.S.C. § 360. It is a violation of the FDCA to operate an unregistered
drug facility, 21 U.S.C. § 331(p), and a drug that is manufactured in an
unregistered facility is deemed to be misbranded. 21 U.S.C. § 352(o).
One of the drugs at issue in this case is not heroin or cocaine, but is a
drug of abuse. GHB has become popular because, like many abused drugs, it
produces a "high" or a trance-like and euphoric state. It is known under
various names such as gamma hydroxybutyrate, gamma hydroxybutyric acid sodium
salt, and sodium oxybate, and is commonly known as "GHB." GHB is sold in both
liquid and powder form, and can be made rather easily.
- Information Regarding Gamma Hydroxybutyrate
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.
In 2002, FDA 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 was promoted illegally by the defendant for strength training, body
building, weight loss, sleep inducement, as a sexual stimulant, as a
psychotropic drug, and as a replacement for L-Tryptophan, the food supplement
that FDA ordered removed from the market in 1990 after it was linked to a rare
On November 7, and 8, 1990, the state of California and the FDA,
respectively, issued press releases warning consumers against the use of GHB.
Consumption of GHB (in amounts as small as 1/2 to 3 teaspoons to be dissolved
in water or a few ounces taken directly) has caused users to experience
nausea, vomiting, tremors, severe respiratory problems, blood pressure drop,
seizures, and coma. The deleterious effects of GHB occur almost immediately
after ingestion. Consumption of GHB and other central nervous system
depressants, like alcohol, can and has resulted in death.
[updated November 2002]
[cited in Civil Resource Manual 15]