"Black-markets" exist for several types of drugs that lead to prosecutions under the Food, Drug, and Cosmetic Act (FDCA). These include new drugs that are not yet controlled substances, performance enhancing drugs, and animal drugs that are distributed outside FDA regulated channels. The issues that arise in these cases differ from issues in Controlled Substances Act cases. "Buy-bust" scenarios in these areas also raise concerns in addition to those under the Controlled Substances Act.
- Manufacturers and Distributors of Gamma Hydroxy Butyrate (GHB)
Manufacturers and distributors of the body-building and psychoactive drug gamma hydroxy butyrate, or "GHB", operate clandestinely. See this manual at 16 for a description of circumstances in which FDCA violations take place, 17 for sample charges, and 18 for portions of a probation letter.
- Human Growth Hormone
Distributing anabolic steroids or human growth hormone for muscle enhancement is unlawful. Incuded is a description of the evolution of relevant statutes, stating which are currently effective. This section should be consulted before attempting any prosecution involving human growth hormone or anabolic steroids, the latter of which are now controlled substances. Particular care must be used in prosecuting drug-dealing physicians who dispense human growth hormone. See this manual at 19.
- The "Buy-Bust" Prosecution
FDCA cases involving sales of illicit drugs are vastly different from Controlled Substances Act cases. Mere possession of FDA regulated drugs is not generally unlawful. Additional elements of fraudulent intent, interstate commerce, the nature and identity of the product, and "adulteration" or "misbranding" must be established. Rarely, if ever, is a "buy-bust" advisable unless considerable investigation has been conducted. A more detailed discussion of these issues is included in this manual at 20.
- Animal Drug Prosecutions
OCL coordinates investigations into the black market distribution of unapproved drugs intended for use in food producing animals. See this manual at 21 for a general description of the pertinent regulatory framework, 22 and 23 for sample indictments, and 24 and 25 for jury instructions. See this manual at 26 et seq. for a trial memorandum describing issues that may arise. See this manual at 28 for a memorandum regarding expert testimony, frequently required in such cases, and 29 re applying the "intent to defraud FDA" felony theory to an animal drug prosecution.
[cited in USAM 4-8.220]