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Part I: Introduction
The American Association of Poison Control Centers received 6,138 calls for abuse of
designer drugs in 2011.1 A designer drug is defined as a substance created to mimic the effects
of drugs that are explicitly prohibited under federal laws, but [is] not [itself] expressly covered
by federal law.2 These drugs have been known to cause positive and negative reactions similar
to cocaine, ecstasy, and LSD ranging from euphoria to extreme paranoia. 3 In 2012, the Drug
Enforcement Administration (DEA) made significant efforts to charge and convict sellers and
distributors of designer drugs; however, prosecution of these individuals proved difficult. 4
Technology and chemistry advancements have caused rapid innovations in analogue creations,
despite the existence of an analogue provision.5
In 1986, Congress created the Controlled Substance Analogue Enforcement Act
(CSAEA) to deter chemists from creating new drugs that would serve as substitutes for federally
prohibited drugs.6 Specifically, the Act criminalized the creation of controlled substance
analogues, often referred to as designer drugs, by imposing the treatment of a Schedule I
controlled substance under federal law.7 The Act establishes the following definition for a
controlled substance analogue. A controlled substance analogue is a substance that has a
substantially similar chemical structure or substantially similar physiological effect to a
controlled substance.8

1 Devlin Barrett, Bath Salts Pose a Hurdle for Prosecutors, WALL ST. J. (Aug. 14, 2013, 7:52 PM),
http://www.wsj.com/articles/SB10001424127887323420604578650073463695826.
2 Chris Gant, Should There Be A Scienter Requirement for Designer Drugs?, U. CIN. L. REV. (Mar. 26, 2015),
http://uclawreview.org/2015/03/26/should-there-be-a-scienter-requirement-for-designer-drugs/.
3 supra, WALL ST. J. (Aug. 14, 2013, 7:52 PM).
4 Id.
5 supra, U. CIN. L. REV. (Mar. 26, 2015).
6 United States v. McFadden, 753 F.3d 432, 436 (4th Cir. 2014).
7 21 U.S.C. 813 (2010).
8 21 U.S.C. 812 (b)(1), (2) (2010).

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The statute does not define the phrase substantially similar. 9 This omission raises issues of
interpretation and application.
On the one hand, prosecutors have argued that the use of expert testimony may be used to
establish similarities between a chemical and a controlled substance; the determination of
whether a substance is substantially similar should be based on evidence presented and left to the
jury. A chemical would not be established as a controlled substance analogue until after
adjudication.10 On the other hand, defendants in various cases have challenged the
constitutionality of the Act claiming that the language is vague and does not provide fair notice.
A defendant does not have knowledge of what makes a chemical similar to a controlled
substance so much so that an individual would be criminally liable. 11 Furthermore, a defendant
does not have notice of the prohibited chemicals or whether a chemical is substantially similar to
a controlled substance prior to adjudication.12
This matter of notice highlights another omission in the Act which creates an issue of
application: the scienter requirement.13 Because a defendant is not aware of a chemicals status as
a controlled substance analogue until after adjudication, courts are left with the responsibility of
determining whether the Act imposes strict liability or whether a mens rea requirement exists.
Moreover, when it has been decided that a mens rea requirement exists, the requirement has
varied amongst different courts.
Where individuals may look to a court decision for understanding of a law, courts have
varied significantly in their interpretations of the CSAEA such that the law still remains unclear.
9 21 U.S.C. 802 (32) (2014).
10 Gregory Kau, Comment, Flashback to the Federal Analog Act of 1986: Mixing Rules and Standards in the
Cauldron, 156 U. PA. L. REV. 1077,1090 (2008).
11 supra, 156 U. PA. L. REV. 1077, 1090 (2008).
12 Id., at 1090 (2008).
13 Id.

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The CSAEA is vague and does not provide fair notice because it does not define the term
substantially similar nor does it explicitly establish a scienter requirement. The law should be
amended to redefine a controlled substance analogue and establish a mens rea requirement so
that an ordinary person may understand what chemicals will be considered a controlled
substance analogue and what intent for said chemical is required. Such an amendment will allow
Congress to reach the intended objects of the statute without violating due process.
Part II: Different Courts, Different Decisions But the Same Law
The complexities of the CSAEA are illustrated in United States v. McFadden and United States
v. Turcotte.14,15 In McFadden, the defendant was convicted for distribution of several controlled
substance analogues under the Analogue Provision of the Controlled Substance Act (CSA). 16 On
appeal, the defendant argued that the terms substantially similar and human consumption are
too vague to provide fair notice and would result in arbitrary and discriminatory enforcement.
The court affirmed the district courts decision. 17 Specifically, on the issue of vagueness, Judge
Keenan expressed two reasons for the courts decision. First, the similarities demonstrated by
comparison of the chemical diagrams during expert testimony were sufficient for the purposes of
defining substantially similar and providing notice. 18 Second, the term human consumption
plainly encompasses the use of a substance by a human being in a manner that introduces the
substance into the body.19 The court held that the scienter requirement was met by establishing
that the defendant intended the substance for human consumption.

14 United States v. McFadden, 753 F.3d 432 (4th Cir. 2014).

15 United States v. Turcotte, 405 F.3d 515 (7th Cir. 2005).
16 McFadden, 753 F.3d at 437.
17 Id. at 446.
18 Id. at 440.
19 Id.
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The court in United States v. Turcotte interpreted the statute differently, however, recognizing the
nexus between the issues of vagueness and the scienter requirement. 20 In Turcotte, the defendant
was convicted for possession and distribution of controlled substance analogues.21 The defendant
appealed the district courts decision arguing, the Analogue Provision of the CSA is
unconstitutionally vague.22 The Seventh Circuit affirmed the district courts judgment.23 Judge
Cudahy addressed the issue of scienter before the issue of vagueness. 24 The court noted that a
defendant is not aware of a substance as a controlled analogue until after adjudication and,
consequently, applying a direct and literal scienter requirement would threaten the very purpose
of the Act.25 As such, the court held that the scienter requirement is met when a defendant knows
that a chemical has a substantially similar structure to a controlled substance and knows that the
chemical has similar physiological effects or intend[s] or represent[s] that it has such effects. 26
The jury is allowed to infer that if the defendant knew the substance had similar physiological
effects of a controlled substance then the defendant also knew that it had a substantially similar
chemical structure to a controlled substance.27 Moving to the issue of vagueness, the court
reasoned that where the scienter requirement has been met, it is difficult to prove vagueness
because the requirement is robust.28 The court also noted that circuit courts have consistently
held that the Analogue Provision of the CSA is not unconstitutionally vague.29

20 United States v. Turcotte, 405 F.3d 515, 531 (7th Cir. 2005).
21 Id. at 518.
22 Id.
23 Id.
24 Turcotte, 405 F.3d at 525
25 Id. at 527.
26 Id.
27 Id.
28 Turcotte, 405 F.3d at 531.
29 Id.
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While both courts decided that the Analogue provision is not unconstitutionally vague and it
provides fair notice, the cases are distinguished from United States v. Forbes. In Forbes, the
court decided that the Analogue Provision of the CSA was unconstitutionally vague as applied to
the substance at issue, alphaethyltryptamine (AET). 30 Judge Babcock reasoned that AET had
been developed and marketed as an anti-depressant for several years.31 Three out of four experts
testified that AET did not have a chemical structure substantially similar to a controlled
substance.32 The fourth expert, however, testified that AET is similar to a controlled substance
because it share[s] a structural family root . . . [and] produce[s] some degree of hallucinogenic
and stimulant activity as the controlled substance to which it was being compared.33 Judge
Babcock noted that other scientists disagreed.34 Because of the lack of consensus, the court held
that the Analogue Provision of the CSA was indeed unconstitutional. 35 On the issue of scienter,
the court stated, a defendant does not have to know that a substance has a substantially similar
chemical structure to an illegal drug.36
McFadden, Turcotte, and Forbes all present significantly different approaches to the Analogue
Provison of the CSA. These different approaches, however, do not provide an actual definition
for the term substantially similar. Indeed, Judge Cudahy in the Turcotte decision notes that a
defendant will not know if a chemical is substantially similar until after adjudication. 37 Yet, as
evidenced in Forbes, determination of a chemical as substantially similar can be a

30 United States v. Forbes, 806 F. Supp. 232, 239 (D.Colo. 1992).

31 Forbes, 806 F. Supp. at 233.
32 Id.
33 Forbes, 806 F. Supp. at 234.
34 Id.
35 Forbes, 806 F. Supp. at 239.
36 Id. at 238.
37 Turcotte, 405 F.3d at 526.
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disagreement among scientists.38 Furthermore, each court established a different scienter
requirement based on the interpretation of substantially similar.
The term remains unclear and ever changing with each new case. Consequently, the scienter
requirement also continuously varies without any similarity amongst courts. Congress has not
made any changes to the statute to define the term substantially similar or to set an explicit
scienter requirement.39
Part III: You Can Have A Far-Reaching Provision and Define It Too
The statute as it exists now does not provide notice to a defendant primarily because it does not
establish a specific rule for what makes a chemical substantially similar. As forensic scientists
have pointed out, the term has no quantifiable meaning and thus requires experts to testify
based on little more than subjective feelings.40 An individual cannot properly conduct him or
herself within legal limits because of lack of knowledge as to the meaning of the term. 41 The
decision to leave the term undefined in the statute may be because of the rapid advancements in
chemistry and technology that allow chemists to continuously make minor adjustments to a
molecule and avoid criminal liability.42 However, this has not rendered the statute completely
effective and has only resulted in problems of interpretation and application.43
Gregory Kau offers a solution to this problem.44 In his article, Flashback to the Federal Analog
Act of 1986: Mixing Rules and Standards in the Cauldron, Kau analyzes the standards-based
model of the Federal Analog Act.45 He demonstrates that a standards-based model provides only
38 Forbes, 806 F. Supp. at 234.
39 21 U.S.C. 812 (b)(1), (2) (2010).
40 Garrett Epps, Too Vague to Be Constitutional, THE ATLANTIC (Apr. 17, 2015, 6:15 AM),
http://www.theatlantic.com/politics/archive/2015/04/too-vague-to-be-constitutional/390762/.
41 supra, 156 U. PA. L. REV. 1077,1090 (2008).
42 supra, WALL ST. J. (Aug. 14, 2013, 7:52 PM)
43 supra, 156 U. PA. L. REV. 1077,1087 (2008).
44 supra, 156 U. PA. L. REV. 1077, 1107 (2008).
45 Id.,156 U. PA. L. REV. at 1077

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ex post content to the law whereas a rules-based model provides ex ante content; to the
law.46 A rules-based model presents, again, the challenge prosecutors face in the advanced
ability of chemists to quickly create new analogues.47 A standards-based model presents, again,
the issue of fair notice.48 In response to this dilemma, Kau presents a hybrid model that mixes
both rules and standards.49
This hybrid model provides that Congress create a statutory definition of controlled substance
analogue as a chemical that is substantially similar to (1) a currently scheduled chemical, or (2)
a chemical that has previously been considered a controlled substance analog, with the
stipulation that a chemical is substantially similar to another chemical if it differs only by an
unsubstituted functional group.50 This definition creates a clear threshold because it quantifies
the term substantially similar. In Forbes, one expert determined that a chemical was
substantially similar to a controlled substance by analyzing the root molecule of the chemical but
another expert came to a different conclusion by analyzing the amine groups of the chemical. 51
Kaus definition creates a universal standard by establishing the aspect of the chemical that
should be analyzed. If a chemical differs by a substituted functional group, than it is not
considered a controlled substance analogue. A chemist is on notice of whether his or her
conducts is within legal limits because the term substantially similar is defined simple
terminology.52
Furthermore, chemists will not be as easily able to tweak a molecule and avoid criminal
liability under the statute because the Kaus definition also includes currently scheduled
46 Id.,156 U. PA. L. REV. at 1089
47 supra, WALL ST. J. (Aug. 14, 2013, 7:52 PM)
48 supra,156 U. PA. L. REV. 1077, 1090 (2008).
49 Id.,156 U. PA. L. REV. at 1107 (2008).
50 Id.,156 U. PA. L. REV. at 1109 (2008).
51 Forbes, 806 F. Supp. at 234.
52 supra, 156 U. PA. L. REV. 1077, 1110 (2008).
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chemicals. As he explains, if a court found that a chemical was an analog, the definition would
expand to encompass all immediate permutations of that analog, which would allow the law to
provide both clear notice and also to keep pace with black market entrepreneurs. 53 Kaus hybrid
model clearly defines the term substantially similar and presents a solution for both
prosecutors and defendants.
In addition to a hybrid-model, Kau also suggests that the DEA creates an official list of
potential chemical analogs.54 This solution is quite simple. The list would be composed of
chemicals that are similar structures to controlled substances and controlled substance analogs. 55
A list of potential chemical analogs weakens a defendants argument of fair notice. The
defendant will have the ability to check the list and assure that a chemical is or is not a potential
analog. If the chemical appears on the potential analog, the defendant is on notice that he or she
may be criminally liable if the chemical meets the substantially similar standard as clearly
defined in Kaus hybrid model. Under a hybrid model approach with a potential chemical analog
list, the issue of vagueness is eliminated because the term substantially similar is defined in
layperson terms and a defendant has multiple means of notice.
While the hybrid model addresses the issue of vagueness, it does not address the issue of
the scienter requirement. The scienter requirement has changed with each courts decision. In
Forbes, the court held that the scienter requirement did not exist, implying strict liability.56 This
approach is regarded with disfavor for drug charges like the CSAEA. 57 Indeed, Justice Thomas
held in Staples v. United States, absent a clear statement from Congress that mens rea is not
required, [the Court] should not apply the public welfare offense rationale to interpret any statute
53 Id.
54 supra, 156 U. PA. L. REV at 1113.
55 Id.
56 Forbes, 806 F. Supp. at 238.
57 supra, 156 U. PA. L. REV. 1077, 1090 (2008).
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defining a felony offense as dispensing with mens rea. 58 As the CSAEA is a federal law, the
mens rea requirement should not be dispensed. It remains unclear, however, what should be the
exact men rea requirement.
In Turcotte, the court decided that the mens rea requirement was be based on the
chemical structure of the substance; whereas the court in McFadden decided that the mens
requirement was based on the intention for human consumption. A similar distinction is
demonstrated in Posters N Things, Ltd. v. United States.59 The Court in Posters N Things, Ltd.
highlighted the difference between the purposes of manufacturers design and the purpose of the
consumers intended use.60 Justice Blackmun noted that a manufacturers design intention might
be entirely different from the consumers intentions for use, with the latter being understood
objectively.61 As such, the Court renounced both implementations of the scienter requirement
and, instead, held that the mens rea requirement was based on the defendants knowledge of
likely use.62 Justice Scalia, concurring, noted that under such an approach, all objective
manifestations should be considered.63
The approach taken in Posters N Things, Ltd. for the scienter requirement best fits the
Analogue Provision of CSA. The CSAEA does not create an exemption of medical research. 64
Under the Turcotte approach, which is design-focused, a chemist would be criminally liable for a
controlled substance analogue even if the substance were created solely for the purposes of
medical research. As long as the chemical is substantially similar in structure or physiological
58 Staples v. United States, 511 U.S. 600, 618 (1994)
59 Posters N Things, Ltd. v. United States, 511 U.S. 513 (1994) (addressing the issue of the scienter requirement
for the Mail Order Drug Paraphernalia Control Act; the defendant sold various items of drug paraphernalia using
themail system.).
60 Posters N Things, Ltd., 511 U.S. at 518.
61 Id. at 521.
62 Posters N Things, Ltd., 511 U.S. at 524.
63 Id. at 530.
64 supra, 156 U. PA. L. REV. 1077, 1110 (2008).

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effect to a controlled substance, the chemists intent is irrelevant. The same result would occur
under the McFadden approach. A chemist would be criminally liable for creating a medicine that
is substantially similar to controlled substance even if it is for the purposes of medical research.
If the chemical is intended for human consumption, again, the chemists intent is irrelevant.
The Poster N Things, Ltd. approach targets the appropriate group of chemists. The
CSAEA was created to prevent clandestine chemists from taking advantage of loopholes in the
Controlled Substance Act.65 Its target is not medical research chemist. Yet, it has the ability to
criminalize such chemist as well. By requiring that the individual had knowledge of its likely
use, a separation between medical research chemists and clandestine chemists is created. It is
reasonable that a jury would determine that a medical research chemists knowledge of likely use
would be limited medical testing; whereas, a jury would determine that a clandestine chemists
knowledge of likely use would apply to use as a controlled substance substitute or recreational
drug.
Further supporting this separation, the DEA should also create a non-binding preliminary
hearing process for potential controlled substance analogs, as Kau suggests. 66 Such a process
would allow scientists to argue in favor of a substance for medical research and obtain approval
from the DEA to continue research.67 A clandestine chemist, on the other hand, would not seek
such a process, as he or she would have no basis for medical research. Where a substance has
been created and the individual is not a medical research chemist, and has not sought the DEAs
approval, a jury may infer that the individual did not create the substance for medical purposes.

65 Id., 156 U. PA. L. REV. at 1086.

66 Id. at 1114.
67 Id.
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The nature of the individuals job and subsequent actions should all be taken into
consideration under this mens rea requirement.68 The scienter requirement that the defendant
have knowledge of the likely use assures that the defendant is aware of the not only the chemical
substance as an analogue but also of the substances likely use in a non-medical manner. This
approach supports the hybrid-models creation of fair notice for defendants while still allowing
prosecutors to intended objects of the CSAEA.
Conclusion
The rapid creation of analogue substances has created a problem in the drug-market for which
Congress has attempted to respond to with the CSAEA. Various court decisions have proven the
statute difficult, at best, to apply because it does not provide fair notice for two reasons. The
approaches taken by courts have rendered the statute ineffective in deterring the creation of
substance analogues.
The omission of a definition for the term substantially similar and a mens rea
requirement leaves courts to determine the definition on a case-by-case basis. A substance is not
considered an analogue until after adjudication. Further, where a drug may have been intended
for medical research, the chemist may be criminally liable. As a result a defendant has no
knowledge of whether his or her conduct is illegal and the DEA must continuously ban new
drugs after they have been created. A new definition of a controlled substance analogue, the
hybrid-model, and preliminary hearings remedy both these issues.
A clearly defined statute deters chemists from creating substances analogues, without
medical purposes, because chemists will have fair notice of which substances will and will not be
considered an analogue prior to adjudication and, more importantly, prior to creation. The current
statute does not offer such deterrence.
68 Posters N Things, Ltd., 511 U.S. at 530. (concurring opinion by Justice Scalia).
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