I. BACKGROUND INFORMATION FOR SUBMISSION TO PROBATION OFFICE
- Background Information Concerning The Statutory
Framework For The Regulation Of Human Drugs
- Information Regarding Gamma Hydroxybutyrate ("GHB")
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.
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 thereof."
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 use.
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.
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 blood disorder.
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]