Federal Analog Act
Editor-In-Chief: C. Michael Gibson, M.S., M.D. 
The Federal Analog Act, 21|813, is a controversial section of the United States Controlled Substances Act, allowing any chemical "substantially similar" to an illegal drug (in Schedule I or II) to be treated as if it were also in Schedule I, but only if it is intended for human consumption. The banned substances are often called designer drugs.
- (A) Except as provided in subparagraph (C), the term controlled substance analogue means a substance -
- (i) the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or II;
- (ii) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or
- (iii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II.
- (B) The designation of gamma butyrolactone or any other chemical as a listed chemical pursuant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph that the chemical is a controlled substance analogue.
- (C) Such term does not include -
- (i) a controlled substance;
- (ii) any substance for which there is an approved new drug application;
- (iii) with respect to a particular person any substance, if an exemption is in effect for investigational use, for that person, under section 355 of this title to the extent conduct with respect to such substance is pursuant to such exemption; or
- (iv) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.
Originally there was no conjunction joining the three conditions of subparagraph (A), but later the word "or" was added to part A(ii), indicating that a substance can qualify as an analogue either by fulfilling part A(iii), or by fulfilling parts A(i) and/or A(ii). Because there is no word such as "and" or "or" at the end of subparagraph A(i), the meaning of this part remains ambiguous, as it is unclear whether a substance can be considered an analogue merely by fulfilling one of parts A(i) or A(ii), or alternatively if both parts A(i) and A(ii) need to be fulfilled.
This is an important distinction, as if only part A(i) needs to be fulfilled, then a compound with a substantially similar structure to a controlled drug but with no pharmacological effect, or completely different effects, could nevertheless be considered an analogue of that controlled drug despite having no abuse potential. Similarly if only part A(ii) needs to be fulfilled then a substance which produces substantially similar effects to a controlled drug despite having a completely different structure, could be considered an analogue of that controlled drug.
Based on the case law it would appear that this section has so far been interpreted to mean that a substance must fulfill both parts A(i) and A(ii), i.e. it must have a structure substantially similar to that of a controlled drug, and produce pharmacological effects substantially similar to those of the controlled drug with which it is being compared, in order to be considered a controlled substance analogue. However this has not been conclusively decided and it is possible that the DEA might attempt a prosecution based on only one of these parts if they felt that it was appropriate, for instance if a new drug started being sold which had effects similar to an existing drug of abuse but which had no structural resemblance to any controlled drug.
Under part A(iii), which can stand alone and is sufficient by itself to cause a substance to be classed as an analogue, any substance which is represented as having similar effects to a controlled drug will be treated as if it were that controlled drug. If you sold ordinary dextrose for the purpose of human consumption, but advertised it as being "like cocaine", you could be prosecuted as if the sugar were actually cocaine.
On the other hand under part C(iv), none of this applies if it can be proven that the substance is not intended for human consumption. It is unclear which way the burden of proof would lie, i.e. whether the defendant would have to prove that the substance was not for human consumption, or if the prosecution would have to prove that the substance was for human consumption. Normally the burden of proof rests on the prosecution, but this is not always the case for certain offences such as those involving drugs or terrorism.
A major flaw in the Federal Analog Act is the lack of any definition of what "substantially similar" means in regards to a controlled drug. Since there is no definition of how similar the structure of a substance has to be to the structure of a controlled drug in order to be considered "substantially similar" under subparagraph A(i), it is impossible to give a definite answer as to whether a novel compound is likely to be considered a controlled substance analogue or not based on analysis of its chemical structure.
Similarly there is no guidance as to how similar the hallucinogenic, stimulant or depressant effect of a novel substance has to be to the effects of a controlled drug in order to be "substantially similar". Since the wording of subparagraph A(ii) states that the effects of the substance in question must be "substantially similar to or greater than" the effects of the controlled drug, it implies that a substance which produces effects that were similar to, but considerably weaker than, the effects of the controlled drug in question, might not be covered by part A(ii).
The lack of any definition of "substantially similar" for either of parts A(i) or A(ii) makes this Act very difficult for lawyers and judges to interpret, and indeed in one of the cases which have dealt with this Act, the wording has been criticized by the judge for being "unconstitutionally vague".
The Federal Analog Act has proven difficult to prosecute under, due largely to the ambiguities in its wording, and usually the DEA will try to use other legislation to prosecute under where possible. However there have been several instances where the Federal Analog Act has been invoked, with varying degrees of success.
Two cases of note have examined the interpretation of the Federal Analog Act in the USA. Firstly, the case of USA v Damon S Forbes (1992) 806 F.Supp. 232, considered the question of whether the drug alphaethyltryptamine (AET) was a controlled substance analogue in the USA. The controlled drugs to which it was alleged that AET was substantially similar were the tryptamine analogues dimethyltryptamine (DMT) and diethyltryptamine (DET).
In this case, the court ruled that AET was not substantially similar to DMT or DET, on the grounds that (i) AET is a primary amine while DMT and DET are tertiary amines, (ii) AET cannot be synthesized from either DMT or DET, and (iii) the hallucinogenic or stimulant effects of AET are not substantially similar to the effects of DMT or DET. Furthermore the court ruled that the definition of controlled substance analogue given in the Federal Analog Act was unconstitutionally vague, in that
“Because the definition of "analogue" as applied here provides neither fair warning nor effective safeguards against arbitrary enforcement, it is void for vagueness.”
The common law principle that the people should have the right to know what the law is, means that the wording of laws should be sufficiently clear and precise that it is possible to give a definitive answer as to whether a particular course of action is legal or illegal. However despite this ruling the Federal Analog Act was not revised, and instead AET was specifically scheduled to avoid any future discrepancies.
The second case that is relevant is the case of USA v Washam (2002) 312 F.3d 926, 930, in which it was considered whether the drug 1,4-butanediol (1,4-B) was a controlled substance analogue in the USA. The controlled drug which it was alleged 1,4-B was substantially similar to was gamma-hydroxybutyrate (GHB).
In this case the court ruled that 1,4-B was substantially similar to GHB, on the grounds that (i) “1,4-Butanediol and GHB are both linear compounds containing four carbons and that there is only one difference between the substances on one side of their molecules”, and (ii) that 1,4-B is metabolized into GHB by the body and so produces substantially similar physiological effects.
It was raised in defence that 1,4-B and GHB contain different functional groups, and that the food additive monosodium glutamate (MSG) also metabolizes into GHB in the body, but these were not held to be grounds to consider 1,4-B not substantially similar to GHB.
It was also raised in the case of Washam that the Federal Analog Act was unconstitutionally vague, but in this case the court rejected this argument on the grounds that the defendant’s actions in concealing her activities and lying to DEA agents showed that she knew her actions were illegal, and furthermore that “…a person of common intelligence has sufficient notice under the statute that 1,4-Butanediol is a controlled substance analogue.” Washman construed the Analogue Act to require parts i) and either ii) or iii), and concluded the Act constitutional upon this construction.
- The actual text of the law
- Pertinent definitions, including the definition of "controlled substance analogue"