Josh D. Lee

Josh D. Lee is a criminal defense attorney (and former police officer) based in Vinita, Oklahoma, who focuses on DUI defense. He is a nationally recognized lecturer on DUI/DWI forensic science–related topics. He has been invited to speak at the American Chemical Society (ACS) National Meeting on three occasions. Josh was recently elected as Forensic Science Co-Chairman for the Chemistry and the Law Division of the ACS. The American Chemical Society has also named Josh an Assistant Chromatography Instructor. He is a published author on the topics of breath testing and gas chromatography, a certified independent operator of the Intoxilyzer 5000 and 8000, and an instructor of the Standardized Field Sobriety Tests. He has been selected as a sustaining member of the National College for DUI Defense. He is also a member of the Oklahoma Criminal Defense Lawyers Association, the Texas Criminal Defense Lawyers Association, the American Chemical Society, and the Oklahoma Bar Association. Josh is a founding partner of the law firm of Ward & Lee, PLC, serving northeastern Oklahoma.

Synthetic Drug Prosecution & Defense


In 1980, designer drugs (e.g., amphetamines, fentanyl derivatives, phenethylamines related to MDMA) in the United States began to enter the marketplace. In response, Congress passed legislation seeking to ban these new designer drugs called the Federal Controlled Substance Analogue Enforcement Act (­FCSAEA) of 1986. After initial litigation of a limited degree, this law laid largely dormant until a couple of years ago. It is expected that FCSAEA-based prosecution will increase exponentially in the next several years. This anticipated resurgence in FCSAEA-based prosecutions is traceable to the modern phenomenon of synthetic drugs. PiHKAL: A Chemical Love Story is a 978-page paperback published in September 1991, written by Dr. Alexander Shulgin and his wife Ann Shulgin, which launched the careers of many new, modern-day unlicensed pharmaceutical entrepreneurs.1 With the highly profitable endeavor of synthetic drug production flooding the marketplace, federal and state legislatures have had a difficult time keeping up with the illicit trade. They have tried to keep pace with the development of synthetic cannabinoids and synthetic cathinones such as the naphthoylindoles; naphthylmethylindoles; naphthoylpyrroles; naphthylideneindenes or naphthylmethylindenes; phenylacetylindoles; cyclohexylphenols; benzoylindoles; quinolone-based synthetic cannabinoids; HU-210; dexanabinol or HU-211; WIN 55,212-2; benzylpiperazines; phenethylamines; tryptamines; pyrrolidinophenones; and the like. But it is a daunting task. Regulation is difficult, because as soon as one compound becomes scheduled and therefore illegal to possess, the makers of these drugs quickly switch to another compound—one that has the same or similar pharmacological effect but is a different chemical structure and is therefore not a scheduled substance.

This article will examine the prosecution of controlled substance “analogs” by both the state and federal governments. At the end of this read, the reader will have appreciation for the controlling law, the scientific problem of defining an analogue, the current efforts in the forensic science community to define an analogue, and the new chemical defense as seen in the case of Ohio v. Silmi et al.2

The Current State of the Law

The traditional reaction of both federal and state legislatures has been to resort to “analogue acts.” The first of these analogue acts was passed in 1986 by the federal government. The current form can be found at 21 U.S.C. § 802(32).

The Federal Controlled Substance Analogue Enforcement Act (FCSAEA) of 1986 reads as follows:

(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.

The developed law interpreting the FCSAEA reveals a hodge-podge of decisions. It includes:

Constitutional Challenges Based on the Void for Vagueness Doctrine

  • Definition of “controlled substance analogue” in Comprehensive Drug Abuse Prevention and Control Act is specific enough to give constitutionally adequate notice of misconduct prohibited. United States v. Reichenbach, 29 M.J. 128 (CMA 1989).
  • Controlled Substance Analogue Enforcement Act of 1986 was not unconstitutionally vague as applied, in light of sufficiently precise statutory language to enable ordinary person in position of defendants to know that listed precursor chemicals should not have been possessed for purpose of manufacturing for human consumption, substances similar to amphetamine, methamphetamine, and 4-methylaminorex;  defendants had copy of government notice that methylaminorex was to be scheduled as controlled substance, and had used false names in ordering precursor chemicals. United States v. Hofstatter, 8 F.3d 316 (6th Cir. 1993), cert. denied, 510 U.S. 1131, 114 S.Ct. 1101, 127 L.Ed.2d 413 (1994).
  • Although analogue statute, under which chemical can be considered a drug if it is an analogue to listed controlled substance, was “somewhat elastic,” it was not unconstitutionally vague as applied to defendant for trafficking in aminorex and phenethylamine as analogues to cis-4-methylaminorex and methamphetamine, respectively, since chemical charts would have put reasonable person on notice that substances were substantially similar within meaning of statute. United States v. McKinney, 79 F.3d 105 (8th Cir. 1996), vacated, 520 U.S. 1226, 117 S.Ct. 1816, 137 L.Ed.2d 1025 (1997), on remand, 120 F.3d 132 (8th Cir. 1997).
  • Analogue Act, under which a substance that is substantially similar to controlled substance analogue is itself treated as controlled substance analogue, was not unconstitutionally vague under Fifth Amendment as applied to controlled substance analogues 5-methoxy-N, N-diisopropyltryptamine, also known as “Foxy,” and alpha-methyltryptamine (AMT); defendant had actual notice of Analogue Act and researched and discussed its applicability, thus foreclosing a vagueness challenge, defendant showed witnesses at least one website warning that “Foxy” could be prosecuted under the Analogue Act, defendant attempted to conceal his activity from law enforcement, defendant attempted to obtain precursor chemicals from a supplier alleging that he was a research company conducting a study of their pharmacological effects. United States v. Klecker, 228 F.Supp.2d 720 (E.D.Va. 2002), aff’d, 348 F.3d 69 (4th Cir. 2003), cert. denied, 541 U.S. 981, 124 S.Ct. 1896, 158 L.Ed.2d 482 (2004).
  • Statutory definition of the term “controlled substance analogue” was unconstitutionally vague as applied to 1,4-butanediol, claimed in a drug indictment to be an analogue of the controlled substance hydroxybutyric acid (GHB); there was no scientific consensus as to whether the two substances had substantially similar chemical structures, and it was not sufficient that 1,4-butanediol converted in the body into GHB, particularly in light of several naturally occurring substances that differed from GHB in the same manner as 1,4-butanediol, but which were not prosecuted. United States v. Roberts, 2002 U.S. Dist. Lexis 16778, (S.D.N.Y., September 9, 2002), vacated, 363 F.3d 118 (2d Cir. 2004), on remand, 2005 U.S. Dist. Lexis 9141 (S.D.N.Y., May 16, 2005).
  • Statutory definition of the term “controlled substance analogue” was not unconstitutionally vague as applied to 1,4-butanediol, claimed in a drug indictment to be an analogue of the controlled substance gamma hydroxybutyric acid (GHB), given that 1,4-butanediol differed from GHB by only two atoms and was converted into GHB upon ingestion. United States v. Roberts, supra, 363 F.3d 118, on remand, 2005 U.S. Dist. Lexis 9141 (S.D.N.Y., May 16, 2005).

Definitions and Explanation of the Elements of the Crime

  • Drug may be controlled substance “analogue” only if it meets both chemical structure and pharmacological effects prongs of statutory definition. United States v. Forbes, 806 F.Supp. 232 (D.Colo. 1992).
  • Based on legislative history, ambiguous definition of “controlled substance analogue” in Controlled Substance Analogue Enforcement Act is to be read conjunctively—i.e., substance in order to be “analogue” is required to satisfy both chemical structure prong of statutory definition and either second or third prong, respectively, requiring substantially similar effect on human nervous system or intent to have such an effect. United States v. Hodge, 321 F.3d 429 (3d Cir. 2003).
  • Ambiguous definition of “controlled substance analogue” in Controlled Substance Analogue Enforcement Act is to be read conjunctively—i.e., substance in order to be “analogue” is required to satisfy both chemical structure prong of statutory definition and either have a substantially similar effect on the central nervous system or be purported or intended to have such an effect. United States v. Turcotte, 405 F.3d 515 (7th Cir. 2005), cert. denied, 546 U.S. 1089, 126 S.Ct. 1022, 163 L.Ed.2d 853 (2006).

Interpretation of “Substantially Similar”

  • Methylenedioxymethamphetamine (MDMA), or Ecstasy, could be treated as “controlled substance analogue” under the Analogue Act, even though it had previously been scheduled as Schedule I controlled substance, once Schedule I scheduling was held invalid. United States v. Franz, 818 F.Supp. 1478 (M.D.Fla.1993).
  • Statutory definition of controlled substance “analogue” encompassed wax-and-flour mixture sold as crack cocaine to undercover agent, even though mixture was not chemically similar to controlled substance; mixture fell within third of three disjunctive definitions, “[substance] which [defendant] represents . . . to have a stimulant, depressant, or hallucinogenic effect . . . that is substantially similar to or greater than [that of] controlled substance in schedule I or II.” United States v. Greig, 144 F.Supp.2d 386 (D.V.I. 2001), aff’d in part, reversed in part, 321 F.3d 429 (3d Cir. 2003).
  • Pills containing ginseng and vitamin B, which defendants represented to purchaser to contain schedule I controlled substance, did not constitute “controlled substance analogue” as required for conspiracy to possess and distribute controlled substance analogue conviction; there was no indication in legislative history that Controlled Substances Analogue Enforcement Act was meant to forbid individuals from passing off over-the-counter nutritional supplements or vitamins as controlled substances. United States v. Clifford, 197 F.Supp.2d 516 (E.D.Va. 2002).
  • Chemical structure of 5-methoxy-N, N-diisopropyltryptamine, also known as “Foxy,” was substantially similar to that of DET, a controlled substance analogue, so as to support treatment of “Foxy” as a controlled substance analogue under Analogue Act; “Foxy” and DET shared same core arrangement of atoms, known as tryptamine, which was the core element of a number of hallucinogenic drugs; experts agreed that “Foxy,” which was lengthened by one methyl group, had a slightly higher lipophilicity rating than DET, which meant it had greater ability to penetrate the blood stream. United States v. Klecker, supra.
  • Substance could be a “controlled substance analogue” for purpose of statute stating that a controlled substance analogue shall, to the extent intended for human consumption, be treated as a controlled substance in schedule I, only if it satisfied both the chemical structure prong of statutory definition, and either the second or third prong of statutory definition, requiring either a substantially similar effect on the human nervous system or the intent to have such an effect. United States v. Vickery, 199 F.Supp.2d 1363 (N.D.Ga. 2002).
  • In United States v. Hodge, supra, held that a wax-and-flour mixture sold to undercover federal agent as “crack cocaine” did not constitute “controlled substance analogue” within meaning of Controlled Substance Analogue Enforcement Act as mixture did not satisfy Act’s definition requiring “substantially similar” chemical structure.
  • In United States v. Brown, 415 F.3d 1257 (11th Cir. 2005), cert. denied, 547 U.S. 1023, 126 S.Ct. 1570, 164 L.Ed.2d 305 (2006), the defense called an expert to testify as to what constitutes “substantially similar” in chemistry, and to refute the prosecution’s theory of the case, but the expert was precluded from testifying. That court held that even if this expert witness proffered by defendants in prosecution for conspiracy to distribute a controlled substance analogue to testify concerning the similarity between gamma-hydroxybutyric acid (GHB), a controlled substance, and 1,4 butanediol, an alleged controlled substance analogue, was qualified to testify as an expert, witness’ testimony was based on unreliable methodology unreasonably applied. In that court’s opinion, the proffered expert witness overemphasized the differences between the two chemicals by unnecessarily double-counting a substructure present in GHB but not in 1,4-butanediol, and witness did not know and could not explain how the computer programs he used defined similarity.

Cases that Comment on Knowledge of What the Substance Is as a Requirement

  • A mens rea (scienter) element of the crime exists. This means that to be convicted of possessing with intent to distribute mixtures containing a controlled substance, the prosecution must show that the defendant knew that the substance at issue had a chemical structure substantially similar to that of a controlled substance, and he or she must either have known that it had similar physiological effects or intended or represented that it had such effects. United States v. Turcotte, supra.

The Source of the Disparate Results

The interpretation of a statute can either be amazingly simple or downright complicated. These guidelines are generally referred to as the cannons of construction.

What is happening here, from strictly the legal viewpoint, is the intersection of three powerful principles that interrelate but do not easily work together to produce a meaningful and just interpretation of the law. These separate and distinct principles are (1) in pari material; (2) the strict construction of penal statutes; and (3) the rule of lenity.

  1.   All statutes should be read as a harmonious whole, with its separate parts (such as subparts) being interpreted within their broader statutory context in a manner that furthers statutory purpose. This is called in pari materia. Justice Scalia of the United States Supreme Court once wrote: “Statutory construction . . . is a holistic endeavor. A provision that may seem ambiguous in isolation is often clarified by the remainder of the statutory scheme—because the same terminology is used elsewhere in a context that makes its meaning clear . . . or because only one of the permissible meanings produces a substantive effect that is compatible with the rest of the law.” United Savings Ass’n of Texas v. Timbers of Inwood Forest Associates, 484 U.S. 365, 371, 108 S.Ct. 626, 98 L.Ed.2d 740 (1988) (citations omitted).

  2.   The strict construction of the penal statutes means that all statutes that are penal in nature must be strictly applied (they are to be applied as they are written and nothing “extra” interpreted into them).

  3.   If statutory language is ambiguous, then the rule of lenity applies. If statutory language is unambiguous, the rule of lenity does not apply. Beecham v. United States, 511 U.S. 368, 374, 114 S.Ct. 1669, 128 L.Ed.2d 383 (1994), citing Chapman v. United States, 500 U.S. 453, 463–464, 111 S.Ct. 1919, 114 L.Ed.2d 524 (1991); see also National Org. for Women v. Scheidler, 510 U.S. 249, 262, 114 S.Ct. 798, 127 L.Ed.2d 99 (1994). The rule of lenity requires that “before a man can be punished as a criminal . . . his case must be ‘plainly and unmistakably’ within the provisions of some statute . . .” United States v. Gradwell, 243 U.S. 476, 485, 37 S.Ct. 407, 61 L.Ed. 857 (1917). Lenity principles “demand resolution of ambiguities in criminal statutes in favor of the defendant.” Hughey v. United States, 495 U.S. 411, 422, 110 S.Ct. 1979, 109 L.Ed.2d 408 (1990) (citations omitted); see also United States v. Granderson, 511 U.S. 39, 54, 114 S.Ct. 1259, 127 L.Ed.2d 611 (1994) (“In these circumstances—where text, structure, and [legislative] history fail to establish that the Government’s position is unambiguously correct—we apply the rule of lenity and resolve the ambiguity in [the defendant’s] favor.”); Cleveland v. United States, 531 U.S. 12, 25 (2000) (before choosing a “harsher alternative” interpretation of the mail fraud statute, “it is appropriate . . . to require that Congress should have spoken in language that is clear and definite”) (citation omitted). Two reasons for the rule are that “fair warning should be given to the world in language that the common world will understand, of what the law intends to do if a certain line is passed,” and that “legislatures and not courts should define criminal activity.” Ratzlaf v. United States, 510 U.S. 135, 148–49 (1994), citing McBoyle v. United States, 283 U.S. 25, 27, 51 S.Ct. 340, 75 L.Ed. 816 (1931).

Condition Precedent for Prosecution: Is the Substance Intended for Human Consumption?

Under the FCSAEA, there is a prerequisite of proof that the government must show prior to getting into the pharmacology of the drug or determining the seller’s intent. The government has to affirmatively prove that this substance was intended for human consumption. The government can do this by direct evi­dence. For example, if the seller said the substance will get the buyer high, or the government can prove this by circumstantial evidence if it meets the burden of proof beyond a reasonable doubt. Circumstantial evidence does not give the fact-finder per­mission to lower the burden of proof; instead it merely allows the person to make reasonable inferences based upon other admitted evidence. This is why the producers of these substances cannot avoid criminal responsibility by simply printing “not for human consumption” on the packaging.

The government can use a context to try to meet their burden of proof by showing that the items were being sold in a head shop right next to the smoking devices that promote a sale if you bundle the two together. The government will also frequently attempt to employ a “negative corpus” or “burden shifting” tactic that is framed as “there are no non-human consumption uses for these chemicals so that is direct proof of intended use for human consumption.” (There is no logic in a negative corpus argument. In fact it is illogical.) Another familiar government argument in courthouses is that, “They didn’t come in here and offer any proof that it wasn’t used for human consumption.” This is impermissible burden shifting. At a very threshold issue, if the government cannot prove that it was used for human consumption, then the prosecution must fail.

Essential Elements

Under the FCSAEA, there are two essential elements associated with the second essential element, and they can be proven in the alternative. As is the case with all essential elements, the government has the burden of production to put forth competent evidence as well as the burden of persuasion beyond a reasonable doubt. If the government fails to produce any evidence as to an essential element, then the prosecution must fail, as there is no legal sufficiency for a conviction. The burden of persuasion focuses on the “weight of the evidence.”

The first part of subsection A calls for a structural analysis and an opinion that the molecule is “substantially similar” to a Schedule I or II substance. It is not sufficient to be merely “substantially similar” to any controlled substance whatsoever. So the government must allege and prove the structural similarity to a particular Schedule I or Schedule II substance. If this particular Schedule I or II substance is not revealed in the indictment or information, it would be wise for a criminal defense attorney to apply for a bill of particulars or file a motion seeking that the indictment or information be quashed for lack of sufficient particularity. Without sufficient proof of this first element, there can be no successful prosecution.

If the government does not prove this first element, the verdict must be “not guilty.” To satisfy the first essential element, the government must produce an expert. It is quite clear that what is and is not an analogue is not “within the ken of a lay person.” Even more so, valid structural analysis and comparison of an unknown seized substance to a Schedule I and Schedule II substance is certainly also “beyond the ken of a lay person.” Therefore, expert testimony is required. Usually this is a chemist. This witness must explain the structure and offer an opinion that this particular substance is “substantially similar” to a specific and particular Schedule I or Schedule II drug and not just simply to a controlled substance. The government must prove this opinion beyond a reasonable doubt.

Defense counsel must be very careful to examine closely the qualifications of any proffered expert who testifies in these cases. Meaningful structural examination is not within the scope of the expertise of all chemists. It is infrequently taught in undergraduate chemistry or is typically only covered in cursory fashion. Valid explanation of chemical structures in the typical analogue context requires more than simply two-dimensional simplistic ball-and-stick drawings. In fact, an expert who engages in such a simplistic method as justification for his or her opinion should set off an alarm for defense counsel. If the government is able to produce competent evidence in sufficient weight to satisfy this first essential element, the prosecution is only part way to a conviction, as it must also prove the second essential element.

The second essential element can be proven in one of two ways. Much like the first essential element, if the government does not prove this element in either of the alternative forms, the verdict must be “not guilty.”

The first alternative requires certain sub-issues of proof that: (1) to a human being (2) there is a pharmacodynamic effect similar to or greater than a particular Schedule I or Schedule II substance that produces a stimulant, depressant, or hallucinogenic effect on the central nervous system. At present, there is a wholesale lack of meaningful controlled scientific studies as to the pharmacodynamic effect of these substances. What studies exist are not performed on humans and are instead pharmacokinetic studies on pigs or rats. There is a lack of information on basic pharmacological issues with these substances such as human binding affinities, bioavailability in humans after particular methods of introduction, and the like. Other dubious sources used as references include self or community anecdotal reporting through emergency rooms or poison control centers. Finally, as is known in organic chemistry and pharmacology, a seemingly small change in structure can grossly change the pharmacodynamic affect (e.g., tetrahydrocannabinol versus cannabidiol, buprenorphine versus diprenorphine). As one can see, satisfying the burden to prove this prong could be very difficult for the prosecution.

The second alternative way to prove the second essential element simply requires proof that the person represents or intends that the seized substance will have a pharmacodynamic effect similar to or greater than a particular Schedule I or Schedule II substance that produces a stimulant, depressant, or hallucinogenic effect on the central nervous system. Again, much like the “human consumption” aspect of this prosecution, direct or circumstantial evidence can be used to prove this element. This is usually much easier to prove than the first alternative of the second essential element.

Alternative Forms of Laws to Deal with Synthetic Drugs

As of November 2012, 41 states and Puerto Rico have passed legislation that seeks to ban some form of synthetic cannabinoids.3 When it comes to synthetic cannabinoids, some acts passed by state legislatures seek to simply specifically name certain substances that they want to ban.4 This approach provides certainty in terms of the scope of potential prosecution. However, it cannot adapt quickly to changes in the synthetic drug world. For every time one substance is placed on a list, the manufacturers change their synthesis to something different. Only two state legislative (MN and CO) actions mirror the sweeping federal analogue approach as discussed above.5 Some state legislatures have passed statutes that refer to the banning of homologues.6 It is important to note and distinguish between homologues and analogues. A homologue is a specific type of analogue wherein the homologue is a compound belonging to a series of compounds differing from each other by a repeating unit. For example, methanol, ethanol, isopropanol, and butanol are homologues by just adding a CH2 group through that progression of chemicals. This homologue approach is not nearly as sweeping as the federal analogue approach. Other state legislatures have passed class-based legislation to ban certain types of synthetic cannabinoids.7 The difficulty with a class-based system is that the testifying expert must wholly understand structure and be able to articulate well to a lay jury what these classes are and how the substance clearly falls into the proposed task. Another drawback comes from public notice of what is or is not legal. For example, a layperson will find written in such a statute the banning of all naphthoylindoles and will search in vain for JWH-018. Therefore, there can be understandable confusion for the layperson who wants to comply with the law but cannot because of hyper-technical definitions that he or she cannot fairly be expected to know. In a class-based strategy, the average layperson will not find a listing of specific substances. As such, the actual notice of prohibited substances is at best lacking and at worst misleading.

A minority of state legislatures (CO and OK) have taken a receptor-based approach.8 The receptor-based approach makes a substance illegal if there is “binding activity at one or more cannabinoid receptors” or “is a cannabinoid receptor agonist and mimics the pharmacological effect of naturally occurring substances.”9 This receptor-based approach can be difficult because it can be argued that it is very broad in its effect and leads to ostensibly irrational results. For example, there is some research that shows acetaminophen indirectly affects CB1 receptors. Acetaminophen’s metabolite N-arachidonoylphenolamine (AM404) increases endogenous cannabinoids like anandamide and 2-Arachidonoylglycerol by inhibiting FAAH (fatty acid amide hydrolase). FAAH metabolizes anandamide (an endogenous cannabinoid) and 2-Arachidonoylglycerol.10

As of November 2012, nine state legislatures (MD, MA, NV, NH, NJ, NY, OR, VT, and WA) have not passed any form of synthetic cannabinoid laws.11 However, as of November 2012, of those states NY, OR, and WA have elected to use departmental rules to ban some forms of synthetic cannabinoids. This leaves MD, MA, NV, NH, NJ, and VT with either a legislative enactment or a department-based ban for synthetic cannabinoids.

As of November 2012, 43 states and Puerto Rico have passed legislation that seeks to ban some form of synthetic cathinones.12 The banning of these types of substances has proven to be more difficult to define for state legislatures. Most states have opted to simply list specific compounds to ban.13 A minority of states simply have a class-ban system in place. The difficulty in this approach is that defining a class or classes proves to be more difficult than in the cases of synthetic cannabinoids.

As of November 2012, eight state legislatures (CA, MT, NE, NH, OR, VT, and WA) have not passed any form of synthetic cathinone laws.14

As of November 2012, three state legislatures (OR, VT and NH) have taken no action on either synthetic cannabinoids or synthetic cathinones.15 Vermont and New Hampshire have taken neither state legislative action nor departmental regulation action.

Yet another possible way of regulating these synthetic drugs has recently emerged. It is a pharmacology-driven definition. In this case, the law says that the government must prove pharmacological effect similar to or greater than a Schedule I or Schedule II drug AND chemical structural class (in that order). If they cannot prove the pharmacological effect similar to or greater than a Schedule I or Schedule II drug, structural class never even comes into consideration. In such a statutory scheme, a chemist (alone) could not testify to a drug being a substance under that type of law even if that specific drug was listed as an example under a listed structural class. Because of this interpretation, it is misleading to the court to produce a chemistry report that says anything that could be interpreted as “Drug X is a controlled substance or its analogue.” Instead, a pharmacologist would need to testify as to the substance’s effect on a human being and then a chemist as to its structure. This approach proves difficult for the government, as it might require two experts as opposed to one, but this method is very appealing for constitutional reasons.

When the DEA, Congress, or some other legislative or rule-making body makes something illegal, it is a taking of property, plain and simple. It is depriving an individual of a property right. As such, it is subject to Due Process review (good old fashioned Fifth Amendment or Fourteenth Amendment). As this Due Process claim does not involve a suspect or quasi-suspect class or a fundamental right, it defaults to the rational basis test. The rational basis test simply means that the government has to have a legitimate reason for a law or regulation that is rationally linked to it (in other words, the connection is not a non sequitur). In order to survive a true constitutionally based challenge, one must word any statute seeking to ban these synthetics in the pharmacology-driven model so that the pharmacodynamic effect must be proven first before it can be criminalized. Otherwise, we have no rational relation to the harm trying to be prevented. In other words, we are banning things (which is a form of taking of property rights) without linking them to a demonstrated harm. Banning things for the sake of banning them and depriving people of a property interest without reason is unconstitutional and cannot be tolerated.

The Conflagration of Science and the Law

We could start this section with the concept that lawyers and legislators make laws and infrequently consult with the scientists who are the experts on this subject matter. This is how we come up with the term of “analogue” and in particular the idea of “substantially similar” that we see in the statutes. This is the root cause of all of the difficulty in the courtroom.

According to the dictionary, an analogue is “a chemical compound that has a similar structure and similar chemical properties to those of another compound, but differs from it by a single element or group. The antibiotic amoxicillin, for example, is an analogue of penicillin, differing from the latter by the addition of an amino group. Compare homologue.”

This is not totally clear. What is “substantially similar”? A number of tests have been devised by courts in the area of intellectual property to determine “substantial similarity.” None of these tests are particularly useful. Sometimes they border on circular logic, such as one appellate court that defined a “substantially identical” claim as one that is “without substantive change.” Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1346 (Fed. Cir. 1998). The tests used in the intellectual property world may rely on expert or lay observation and may subjectively judge the essence or critically analyze its elements. Again, this is not much help.

Ultimately, no matter what scientific consensus may or may not develop, the question of substantial similarity is a question of fact to be determined by a jury, just like in the area of patent or copyright law.

The real world issue is that having no written standard or guidance document in the scientific community that provides support or instructions to testifying experts is akin to living in the wild, wild west. There is no law. Everyone is allowed to opine as they wish with no real consequences for being either too broad (such as saying anything with a carbon in it is an analogue to a Schedule I or II) or too narrow (such as requiring nearly identical copying of the Schedule I or II drug).

Efforts to Define Analogues by Organizations

The Scientific Working Group for the Analysis of Seized Drugs (SWGDRUG) has posted the DRAFT document “SWGDRUG Recommendations on Analogues and Structural Class Determinations.”16 It is a very short document and really does little to solve the scientific issue in the courtroom. It reads as follows:

SWGDRUG Recommendations on Analogues and Structural Class Determinations

■ 1 Introduction

   1.1   This section provides general recommendations regarding analogues and structural class determinations.

   1.2   Jurisdictional requirements for such determinations may include structural or pharmacological (real or purported) similarity to known controlled substances or structural class definitions.

   1.3   SWGDRUG considers it fundamental for analysts to fully understand how analogues and structural classes are legally defined in a particular jurisdiction prior to de­vel­op­ing or reporting opinions.

   1.4   Such opinions should only be rendered by those with proper training and experience.

■ 2 Analogues

   2.1   The requirements for legal consideration as a controlled substance analogue are defined in jurisdictional legislation.

   2.2   Classification as a controlled substance analogue generally involves the evaluation of the similarity of structure or pharmacological properties of a chemical compound to a known controlled substance.

   2.3   The scientific evaluation of similarity may be made using a variety of techniques and approaches depending on the specific question being addressed. These specific comparisons can be broadly classified by structure, chemical properties, biochemical or pharmacological activity.

   2.4   Evaluation of similarity shall include comparisons of an appropriate nature sufficient to meet jurisdictional requirements.

   2.5   The evaluation of similarities between chemical compounds should be documented. This should include a dis­cus­sion of how the compounds are similar and how they are different.

   2.5.1 Evaluation of similarity is a subjective matter and opinions may differ.

   2.5.2 Structural comparisons in a forensic laboratory are likely to be limited to the structural class and functional group, ring or chain substitutions. As examples, isomers, homologues, salt forms, esters, and ethers may be considered. The scope of comparison conducted should be made clear in the report.

   2.6   Structural similarity between two chemical compounds is not an adequate basis to infer similar pharmacological activity.

   2.7   Likewise a lack of structural similarity is not an adequate basis to infer a lack of analogous pharmacological activity.

   2.8   If pharmacological activity is a requirement of particular legislation, the drug analyst should limit his inference and considerations to the citation of peer-reviewed literature, or relevant sworn statements in legal proceedings in absence of specific training and experience in pharmacology (or related fields).

■ 3 Structural Class Determinations

   3.1   In many jurisdictions, chemical compounds are controlled based upon structural class definitions (e.g., 3-(1-naphthoyl) indole with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not substituted on the naphthoyl ring to any extent).

   3.2   A structural class determination may be made by identifying a specific compound and assigning the compound as a member of a legal structural class.

   3.3   A structural class determination may also be made using an analytical scheme designed to identify sufficient features of a compound to assign it as a member of a legal structural class without making a conclusive identification of that compound (e.g., ortho, meta, or para position of a halogen on an aromatic ring).

   3.4   Any relevant limitations of the analytical scheme and resulting classification shall be clear in reporting.

■ 4 Reporting

   4.1   All conclusions and opinions expressed in written or oral form shall be based on sufficient supporting evidence, data, or information.

   4.2   The basis of any conclusion should be completely documented in the case notes and summarized in the written report and subject to the laboratory’s review policy.

   4.3   Conclusions and opinions reported shall be accurate, clear, objective, and meet the jurisdictional requirements. The report must also include any assumptions or limitations (e.g., potentially exculpatory information), to allow the court to make the final decision.

   4.4   The report should clearly indicate what elements of the legal requirements were evaluated and what elements were not evaluated.

   4.5   The scope of opinions and conclusions reported shall not go beyond the knowledge, training, and experience of the analyst.

A much more promising and robust effort that is, by the group’s mission statement apolitical, is being made by the members of the Advisory Committee for the Evaluation of Controlled Substance Analogs (ACECSA). According to their website, “The mission of the Advisory Committee for the Evaluation of Controlled Substance Analogs (ACECSA) is to recommend min­i­mum standards for the evaluation of non-controlled substances be­ing considered as analogs of controlled substances.”17 They have different subcommittees that are based upon a logical exploration of what should be examined when we try to better understand what is or is not an analogue and what is or is not “substantially similar.” The subcommittees include:

  • Structure (chemical backbone, functional groups, core struc­ture, 3-D structure, presence and location of double bonds and rotatable bonds)
  • Physicochemical Properties (chemical reactivity, ex vivo, in vivo, computation/empirical data, physical properties)
  • Computation Chemistry and Cheminformatics (Molecule similarity algorithms, QSAR, maximum common substructures, Tanimoto value)
  • Literature Support (published, unpublished, dissertations, research, meeting abstracts)
  • Synthetic Pathway (distinct routes separately patentability and publishability, impurity analysis)
  • Pharmacology/Toxicology (pharmacodynamic impact)

Modern Problems to Old Statutes: A Case Study of Ohio v. Silmi et al., U.S. v. Fedida, and Hammel v. U.S.

In 2012, Judge John J. Russo of the Cuyahoga County Common Pleas Court held a Daubert hearing on the issue of the definition of “what is an Analogue” and what is “substantially similar.” The case was The State of Ohio v. Mahir Silmi at al.18

In Silmi the defendants were charged with felony counts of Trafficking and Possession of Controlled Substance Analogs. The defendants filed a motion to exclude the laboratory reports and testimony from the state’s expert witness regarding the alleged controlled substance analogs based upon the premise that the testimony would be purely subjective opinions and therefore should not be admissible.

In December 2012, the court held a Daubert hearing to evaluate the admissibility of the state’s lab report as well as the proposed testimony regarding the testing. Two members of the Cuyahoga County Regional Forensic Science Laboratory (CCRFSL) drug chemistry section testified at the hearing: Paul Boggs, the supervisor of the lab’s chemistry drug section, and Gagandeep Sran, the chemist who analyzed the potential analogues in this case.

Boggs testified that when a substance arrives at the lab, the CCRFSL analyzes not only for controlled substances, but also to see if the substance has a chemical structure “substantially similar” to a controlled substance. If one chemist at the CCRFSL believes the substance to be “substantially similar,” then it would be staffed by lab personnel and looked at by the other six chemists of the CCRFSL. Only if all of them agree that the drug is “substantially similar” would the lab issue its scientific opinion that the standard of substantial similarity has been met and re­port the substance out as an illegal analog.

There were no specific guidelines set by the laboratory to perform this method when it first began. However, over time, two guidelines were developed. First, with regards to synthetic cannabinoids, the chemists determined that an alleged analog drug “had to be within the same chemical family” as the controlled substance. Second, the original backbone of the scheduled substance had to be unchanged for it to be an analogue. This second step was performed by a side-by-side comparison of the stick and letter chemical structures of the suspect drug and the scheduled drug. The testimony also disclosed there was “no statewide database, protocols, or any formal organization or mechanism of standardization regarding the testing of poten­tial analogs.”

The lab used this exact process to test the substances at issue in Simli. Ultimately, the lab concluded that the substances were analogs of JWH-018 (with an additional fluorine atom) and methcathinone (differences in the nitrogen rings).

The court relied upon Ohio Evidence Rule 70219 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993),20 in deciding whether or not to allow the testing and opinion testimony in at trial.

The court ultimately concluded that the testing and proposed testimony were not sufficiently reliable enough to be allowed into evidence.

In reaching its decision, the court focused heavily on “evaluating the theory [of the testing], not the conclusion [drawn by the lab].”21 The court’s finding was that the testing implemented by CCRFSL was not objective or reliable, and that the term “substantially similar” was vague and undefined, leading to an “unguided subjective testing procedure.” The state’s own witnesses even admitted that the test is a subjective one, explaining: “It is based on something. It is just not based on something the way we would like it to be based on.” Id. This is clearly a problem for the testing procedure when Daubert and the rules of evidence require the theory of the test to be “objectively verifiable or derived from widely accepted knowledge, facts, or principles.”22

The bottom line for the court was that the term “substantially similar” was too vague for anyone to be able to properly implement it. Without better guidance the lab would be “left guessing if it is doing the right thing” and forced to “develop a test they hoped met this vague standard.” Id. This means there was no way to determine if the procedure actually produced an accurate result.

United States v. Fedida, 942 F.Supp.2d 1270 (M.D.Fla. 2013), and Hummel v. United States, Cause No. 8:12-mj-1457-T-37 (M.D.Fla., April 30, 2013),23 were both heard in the United States District Court in the Middle District of Florida–Tampa Division in December 2012. There was a consolidated hearing involving the same drug. The court examined whether UR-144 and XLR-11 are analogs of the specifically banned drug JWH-018. The court held that 2-D structures are appropriate models for comparison of these drugs, and that three-dimensional models add nothing to the discussion to change the planar examination of the structure. The court also held that the substances at issue in the case shared the same core structure and therefore met the definition of analogue. The court was referring to the indole core structure (which would include clearly ridiculous outcomes like making tryptamine found in turkey and Cialis analogues of JWH-018) and contained two substitutions at the 1 and 3 positions. The court held that the only meaningful difference with these drugs was the replacement of the cyclopropyl ring for the naphthalene ring structure. The court rejected the six defense experts and accepted the DEA chemist assertion that the substitution was of minor significance.


We hope that the reader now has a better understanding of how the controlled drug analogue statutes are interpreted and en­forced. The reasons for passing laws targeted at so-called drug ana­logues is understandable, but the reality of enforcing the laws proves to be very difficult. Like other areas of forensic science, it is imperative for the defense attorney to have a solid understanding of the science and how it is applied. With appropriate knowledge, the defense can be effective at fighting these cases and exposing the very subjective nature by which the testing is performed. Justice should be a function of empiricism and should not differ based upon geography or simply on a whim. These analogue acts certainly raise a question as to whether or not this is so.

Most importantly, when jurors and judges are shown the true and complete way that analysis is performed and how laboratory analysts reach conclusions, confidence in the ultimate conclusion is undermined. The scientific truth must be told, and it is up to the defense lawyer to tell it. Rest assured, no one else will.


1. Alexander Shulgin (Author) and Ann Shulgin, PiHKAL: A Chemical Love Story (1991).

2. Ohio v. Silmi, Cause No. CR 561754, Judge John J. Russo of the Cuyahoga County Common Pleas Court.

3. Synthetic Drug Threats, National Conference of State Legislatures (2012),

4. Synthetic Cannabinoids (a.k.a. “K2,” “Spice”) Enactments, National Conference of State Legislatures (2012),

5. Id.

6. Id.

7. Id.

8. Id.

9. CO SB 134 (2011) and Ok SB 919.

10. See generally, Bertolini A., Ferrari A., Ottani A., Guerzoni S., Tacchi R., Leone S., “Paracetamol: new vistas of an old drug,” CNS Drug Rev. 2006 Fall–Winter 12(3–4): 250–75; Anderson B. J. “Paracetamol (Acetaminophen): mechanisms of action,” Paediatr Anaesth. 2008 Oct 18(10): 915–21; Prescott L. F., “Paracetamol: past, present, and future,” Am J Ther. 2000 Mar 7(2): 143–7; Graham G. G., Scott K. F., “Mechanism of action of paracetamol” Am J Ther. 2005 Jan–Feb 12(1): 46–55; and Högestätt E. D., Jönsson B. A., Ermund A., Andersson D. A., Björk H., Alexander J. P., Cravatt B. F., Basbaum A. I., Zygmunt P. M., “Conversion of acetaminophen to the bioactive N-acylphenolamine AM404 via fatty acid amide hydrolase-dependent arachidonic acid conjugation in the nervous system,” J Biol Chem. 2005 Sep 9 280(36): 31405-12.

11. Synthetic Drug Threats, supra, n. 3.

12. Id.

13. Substituted Cathinones (a.k.a. “Bath Salts”) Enactments, National Conference of State Legislatures (2012),

14. Id.

15. Id.

16. SWGDRUG Recommendations on Analogues and Structural Class Determinations,

17. “Mission,” (last accessed April 20, 2013).

18. The State of Ohio v. Mahir Silmi et al., CR-12-561754-A,

19. Ohio Evid. R. 702(C) requires that when testimony is based upon scientific information and is reporting the result of a procedure, test, or experiment, that testimony must meet certain reliability requirements. First, the theory upon which it is based is “objectively verifiable or is validly derived from widely accepted knowledge, facts, or principles.” Second, the design of the procedure, test, or experiment must reliably implement the theory. Last, the procedure, test, or experiment must have been conducted in a way that it will “yield an ac­curate result.”

20. “To determine reliability, the Daubert court stated that a court must assess whether the reasoning or methodology underlying the testimony is scientifically valid []. In evaluating the reliability of scientific evidence, several factors are to be considered: (l) whether the theory or technique has been tested, (2) whether it has been subjected to peer review, (3) whether there is a known or potential rate of error, and (4) whether the methodology has gained general acceptance[]. Although these factors may aid in determining reliability, the inquiry is flexible[]. The focus is ‘solely on principles and methodology, not on the conclusions that they generate[].’” Ohio v. Mahir Silmi, CR-12-561754-A, supra at n.18 (citations omitted).

21. Id.

22. The court also had concerns with the fact that the testing procedure had never been formally peer-reviewed and no error rate had been determined. The court noted that the test was developed merely through practice in one laboratory with no formal studies or established methodology upon which to rely.

23. In re Seizure of funds on deposit at Ameriprise Group in accounts 072372469001, 16791187001, and 167911890001, at Pershing Investment in account 3FB300824, at Morgan Keegan/Raymond James in account 32772063, and at Capital One Bank in account 8077989170 (Timothy Hummel v. US) (last accessed May 19, 2013).

PBTs for Drugs: Oral Fluid Collection Devices

Historically, impaired driving was most often linked to alcohol impairment. As such, governments and researchers devised roadside portable breath test (PBT) tools for police to use to identify intoxicated drivers. No such roadside test was possible or necessary for drivers suspected of drug impaired driving—at least until now. The reason for the push for roadside point of contact testing for drugs in 2014 is that drug-impaired driving has become a worldwide safety issue. The use of potentially impairing medication is widespread. Indeed, many drivers operate their vehicles while accidentally under the influence of legally prescribed medication. Recognizing the need for better enforcement, police agencies everywhere are looking for new tools to combat drug-impaired driving. One such experimental tool is Oral Fluid Collection (OFC). It is a means for law enforcement to perform roadside testing of a suspected driver’s mixed saliva for drug impairment with an OFC device (OFCD). The United Kingdom was the first to sanction this type of testing on its driving population.

OFC is said to be able to identify the possible presence of a drug, whether legally prescribed or illegal. The roadside test may also be followed up with a confirmatory technique such as gas chromatography with mass spectrometry (GC-MS). And so, it is the purpose of this article to introduce OFC devices to the reader and describe how they work. We will then explain why we believe OFC devices will be coming to a roadside near you. Finally, we will discuss the application of Frye or Daubert challenges to the admissibility of OFC evidence.

What Is Oral Fluid Collection?

In the world of forensic science, Oral Fluid Collection (OFC) is technically referred to as Mixed Saliva Sampling (MSS). In the non-law enforcement world, however, it is known as Point of Collection Testing (POCT). POCT has been a feature of worksite testing for some time. Police proponents of this testing technique proclaim that it is faster, cheaper, just as accurate as blood or urine but less invasive. Notwithstanding these claims, as we will see with this promising technology, it is not wholly validated or acceptable for judicial use at this time.

How OF-POCT Works

Not all OFCDs work the same way. Each is unique depending on its manufacturer. There are, however, some similarities between the devices—one of which is that they will be used on the roadside just like PBTs are now used. For example, a citizen would have some automobile traffic contact with a law enforcement officer wherein there was some evidence of drug impairment observed and no evidence of alcohol consumption. It would be at this point that the officer would ask the suspect driver to consent to a short OFCD test on a device similar to the one above. However, it is crucial to note that just like the roadside PBTs, the OF-POCT requires a deprivation period. In its instructions and user guide, Drager says that operators must wait 10 minutes before using it.

Whatever device is used by the officer, it usually consists of a collector and a portable reader. The collection OFCD has some sort of tube consisting of an absorbent material at the end to collect saliva from the suspect. Depending on the device, a 1mL sample can be taken from the tongue, gums, inside the cheek, etc., and then placed in the oral screening device. Once the screening process is started, it takes from 2 to 10 minutes to develop a result. After the sample is analyzed, the reader displays whether or not the sample contains any of the drugs it was designed to detect.1 Some readers even have the ability to print out the results of the test for later use; others produce a number indicating the concentration of drugs found, similar to BrAC results; and others simply are displayed on the screen with no method of memorialization. If the results are positive, the suspect might be arrested for drugged driving. We believe that this initial result will likely be treated as presumptive test—as it certainly should, if scientific principles are followed. Later, the motorist would be asked to provide another saliva sample to be used for an evidentiary test. The sampling container would be then transferred to a laboratory where the OF/MSS would be extracted and subjected to either GC-MS or Liquid Chromatography with Mass Spectrometry (LC-MS) analysis, depending upon the laboratory’s analytical abilities.

Example of Analysis Done by One of These Machines

Although there are numerous devices on the market,2 each device uses a slightly different analysis. The Dräger DrugTest® 5000 is already in use in Los Angeles and seems poised to become one of the prevalent devices within the United States. Therefore, in order to gain a better understanding of the device and ways to challenge the use of the device, a description of how the Dräger DrugTest® 5000 works is necessary.3 Currently, the Dräger DrugTest® 5000 is the only device to gain federal approval through NHTSA.

The analytical method used by the DrugTest® 5000 is immunoassay. This analytical tool has been in use for over 30 years.*

Immunoassays begin with injecting a target analyte** into an animal such as a goat. The immune system of the animal will create an antibody to this foreign substance. These antibodies are then harvested from the animal and used in the creation of immunoassay tests. It is only after these antibodies are acquired that the test can be designed and performed.

The antibodies are designed to target the analyte and cause the analyte to bind to the antibody. Think of this like a jigsaw puzzle, where the antibody is the puzzle that has a hole in it for a puzzle piece to fit, and the analyte is that piece of the puzzle. When the puzzle piece (the analyte) finds a spot in the puzzle (antibody) where it can fit perfectly, it will snap into place in (bind with) the puzzle.

Let’s take this one step further and be more specific to the DrugTest® 5000. The immunoassay technique used is a competitive immunoassay. An antibody is added to the test kit as well as a drug conjugate that has been manufactured by the company. The antibody is labeled so that when it binds with something it gives off a detectable color.

Inside the test collection device are strips of absorbent material. Both the antibody and the drug conjugate are placed on this test strip. The labeled antibody is placed towards one end of the strip. In the middle of the test strip the drug conjugate is embedded. This area, where the drug conjugate is embedded, is the detection zone and is where the color change is watched for and measured. The oral fluid sample is placed on the far end of the strip next to where the labeled antibody is.

Now it becomes a competition where any drug that may be present in the sample competes with the drug conjugate to bind with the antibody. Because the oral fluid sample will come into contact with the labeled antibody before the drug conjugate can, then any drug present in the sample will “win” the competition it is having with the drug conjugate and bind with the antibody first. If there is no drug present in the sample, then the labeled antibody cannot bind until it reaches the detection zone and binds with the drug conjugate. When the labeled antibody binds with the drug conjugate, it creates a detectable red line in the detection zone that is then measured with a LED light source and detector.

The detector will measure the amount of color given off by the reaction of the labeled antibody binding with the drug conjugate. The greater the response the more drug conjugate has bound with the antibody, meaning that there was lesser amount of drug, or no drug, in the sample. When a drug is in the sample, then there will be fewer antibodies available to bind with the drug conjugate in the detection zone (because most of the antibodies have already bound with the drug in the sample), and therefore there will be less detectable color. Therefore, the signal amount identified by the detector is inversely proportional to the amount of drug present in the sample: more drug equals less signal, less drug equals more signal (as depicted in Figure 3).

Problems arise with this technique when a substance that is NOT the analyte of interest has a structure similar enough to the antibody that this other substance can bind with it just as the analyte of interest does. When this occurs the immunoassay test will show a positive result for presence of the target analyte even though the target analyte is not in the sample. This is a false-positive result known as cross reactivity.

It is very important to understand that this type of testing is presumptive and subject to many false positives from cross-reactivity. Any results obtained from immunoassay testing must be confirmed by a confirmatory test such as Gas Chromatography Mass Spectrometry.

Why Is Oral Fluid Collection Coming to a Road Near You?

Well, it’s simple: As of January 2014, for 14 states it is already here. OF/MSS is specifically authorized by statute, and some states already have regulations that allow for it.4 In fact, Los Angeles made POCT part of its New Year’s Eve checkpoint effort. Along with PBTs, the officers were authorized to ask drivers if they would consent to a voluntary portable oral fluid test.5 After consent is obtained, the OF is placed into a portable machine; the machine being used was the Dräger DrugTest® 5000,6 which gives immediate results without the need for a blood test.7 Addressing the media and the use of this technology, Los Angeles City Attorney Mike Feuer stated: “Traditionally, our office has focused on drunken driving cases. We’re expanding drug collection and aggressively enforcing all impaired-driving laws.”8

Further illustrating the point, the federal government is stepping up focus on drugged driving and the use of POCT. The Office of National Drug Control Policy, along with the White House, the Department of Transportation, and other Federal Agencies, have taken steps to address drugged driving,9 and several studies have been published on the perceived problem. For example, The National Roadside Survey of Alcohol and Drug Use by Drivers found that in 2007, approximately one in eight weekend nighttime drivers tested positive for illicit drugs.10 Drug Testing and Drug-involved Driving of Fatally Injured Drivers in the United States: 2005–2009, found that roughly one in four of fatally injured drivers who tested positive for drugs were under the age of 25.11 In 2009, narcotics and cannabinoids accounted for almost half of all positive results.12 In that same year, 18 percent of all fatally injured drivers nationwide tested positive for drugs at the time of the crash.13 Finally, the Institute for Behavior and Health published Drugged Driving Research: A White Paper. That paper concluded that drugged driving was a significant domestic and international problem.14 Also, there are many drugs with potential impairing effects being prescribed at a rate higher than we have seen in the history of this country.15 Accordingly, drug-impaired driving has been thrust into the spotlight of law enforcement, media, awareness groups, and lobbyists.

Moreover, federal agencies under the name “National Drug Control Strategy”16 announced their goal not only to reduce drugged driving by ten percent by the year 2015, but also to put the prevention of drugged driving on par with drunk driving prevention.17 Included in their strategy was to “[d]evelop standard screening methodologies for drug-testing labs to use in detecting the presence of drugs.”18

The authors believe that although the strategy calls for standard methodology in laboratories, it is not an inconceivable leap to standardized methodology for testing roadside. These federal agencies have money to fund research. Here, it must be noted that scientific meetings, such as the American Academy of Forensic Sciences as well as the American Chemical Society, are now including presentations and a considerable amount of discussion about this OFCD technology. Government money is pushing research which in turn is pushing innovation. Seizing the opportunity, various for-profit companies such as Dräger, National Medical Services, Cozart Bioscience Ltd., Varian, Branan Medical Corporation, and Innovacon have entered the market and already have viable devices in use. OFC tests that produce rapid and cheap results that can be read onsite by law enforcement officers who have little to no training seem to be an ideal product for supporters of the technology.

Is OFCD Technology Ready for Court?

Regrettably, all of these roadside devices have significant limitations—notably initial costs, limited scope, lack of sensitivity, and non-validation of the method used vis-à-vis unacceptably high rates of false positives.19 Clearly, these limitations underlie the need for improved technology and research.20 The White Paper concluded:

[t]he US lags significantly behind Europe and Australia in its investment in drugged driving research and in applying lesson learned to saving lives and reducing injuries. The evidence that drugged driving is a serious public health and safety problem in the US is strong, as is the evidence that current efforts to combat it are grossly inadequate . . . Improved testing technology also is needed with more sensitive rapid onsite oral fluid tests. . . .”21

The Office of National Drug Control Policy commitment to improving awareness, education, and fighting the ever-growing problem of drugged driving, plus its reliance on the reports discussed above, are evidence of our government’s renewed efforts to combat drugged driving. This will come, as the White Paper encourages, from OFCDs. The criminal defense bar needs to be prepared for these OFCDs. In this regard, it is not a matter of “if we see them” but “when will we see them?” Remember, for most of us, OFCDs will come, but for 14 states, they are already here.

How to Prepare Frye and Daubert Challenges to OFCD Evidence

In order to prepare to defend clients accused of drugged driving and testing by OFCDs, the primary scientific attack should be by Daubert or Frye challenges. We cannot allow the assumption of valid science to enter our courtrooms unchallenged, lest we have more revelations such as those that surround lead bullet analysis, fire science, pattern recognition, and hair and fiber analysis.

Although Daubert superseded Frye in federal courts, there are still several states that continue to follow the Frye standard for scientific evidence.22 The Frye standard is well known:

Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular filed in which it belongs.23

A Frye challenge to OFCD roadside evidence is proper at this point in time because as the White Paper stated, the United States lags significantly behind Europe in terms of drugged driving enforcement. Several European countries have addressed their concerns with drugged driving by approving and commissioning several studies regarding OFC. The below studies show that current OFC technology is not ready for widespread use and is certainly not generally accepted within its field.

From 2006–2008 Driving Under the Influence of Drugs, Alcohol, and Medicines commissioned a study entitled Analytical Evaluation of Oral Fluid Screening Devices and Preceding Selection Procedures.24 This European project focused on the improvement of road safety related to the problem of alcohol, drugs, and medicines. The objective was to give scientific support to the European Union’s transport policy by providing a basis to generate harmonized regulations for driving under the influence of alcohol, drugs, and medicine.

This study looked at eight devices: BIOSENS® Dynamic; Cozart® DDS 806; Drugwipe® 5+; Dräger DrugTest® 5000; OraLab6; OrAlert; Oratect® III; and Rapid STAT®. All of the devices were tested with substance classes: amphetamines, methamphetamines, MDMA or Ecstasy, cannabis, cocaine, opiates, benzodiazepines, and PCP. The study revealed that OF screening tests have only been used in a few countries, but an increasing number are planning to introduce them in the coming years. It acknowledged the benefits that recent drug use is better detected in OFC and it is less invasive than many of the other tests currently on the market. The report, however, acknowledged that there were several issues with the devices. First, none of the tests reached the target value of 80 percent for sensitivity, specificity, and accuracy. The sensitivities for cannabis and cocaine were quite low in all the tests. This problem was further compounded as these two particular drugs are most prevalent in individuals suspected of drugged driving. The study concluded, “the time consuming process of onsite oral fluid screening, in combination with the quite high cost of the devices and the relatively low sensitive for cannabis, which in many countries is the most frequently used illegal drug, will probably prevent large scale testing in practice.”25

Washington’s 2004–2006 ROSITA II Project26 was a study commissioned to roadside-test OFCDs. It tested two devices, the SalivaScreen 5 and the DrugWipe 5, and concluded that the SalivaScreen 5 was not suitable for roadside use as it suffered a large number of failures and was not sensitive or accurate enough to detect marijuana.27 Rosetta II found that DrugWipe 5 fared better, stating that it made interpretation of the results easier and more reliable, that it was easier to use, and that it did not fail. Noticeably absent, however, was any mention of the sensitivity or accuracy to detect marijuana. A chief complaint in the report was the high cut-off rate for marijuana. The officers argued the cut-off rate has to be lower, as other than alcohol, marijuana is the most prevalent drug for DUI-D arrests. Ostensibly, higher sensitivity was not possible for the device.

Finally, the National Highway Traffic and Safety Administration conducted a study entitled State of Knowledge of Drug-Impaired Driving.28 That study discussed OFC testing and its problems. Some issues preclude meaningful use in the field. For example, some drugs inhibit salivary secretions (e.g., MDMA, opiates, and methamphetamine). Without sufficient sample size, the portable machines cannot achieve a valid result. Further complicating this problem, there appears little commutability among devices, with some reporting false positives or false negatives with the same sample. Another problem is that there is no consensus on cut-off levels for the operable portable devices. Almost universally and pandemic across the OFCDs is that their results are not accurate, reliable, or valid for cannabis. Further, there are no nationally established standard methods for oral fluid testing; nor are there any certification programs available.29 In addition to these problems, recent evaluations of available point of collection testing devices indicate that like the European and Washington studies, the specificity, sensitivity, and predictive values for drugs have been poor.30

Additionally, the “cut-off” levels for the kits are set too low for many substances and will absolutely cause the false arrest of non-impaired drivers. For example, consider the oral fluid kit for the Drager device pictured following:

With an amphetamine cut-off level of 50 ng (AMP 50), a lot of people who are properly using therapeutic drugs such as Adderall will be caught by this unnecessary wide net.

Drugs that are taken orally, such as cannabis, or that get into the oral cavity can provide inaccurate results upon confirmatory testing, much like residual mouth alcohol can provide inaccurate BrAC results at roadside with a portable breath test. These over-reported results, based upon contamination, can totally skew the extrapolation of the OFC sample quantitative result by GC-MS to a pharmacodynamic effect. Finally, there are limited studies of insufficient value that translate the quantitative results of OF POCT to traditional blood levels in plasma, making opining as to pharmacodynamic effect nearly impossible.

These and other studies reach similar conclusions—i.e.,31 that the OFCD evidence should not survive a Frye challenge by competent and prepared defense attorneys with good experts.

Here, it must be remembered that these devices are not generally accepted within the scientific community. Although they do have their benefits, such as being less invasive than blood testing and cheaper in terms of collection costs, what they DO NOT have is the ability to give reliable, accurate, and valid results that are generally accepted within the relevant global scientific community.

What if you live in a Daubert state? The Daubert standard replaced the Frye standard in 1992 when the United States Supreme Court decided Daubert v. Merrell Dow Pharmaceuticals. This “new” test abandoned the “generally accepted” standard and instead employed a variety of factors to determine whether scientific evidence is reliable. The factors that were considered:

(1) is the theory, technique, methodology, etc., testable and has it been tested;
(2) has it been subject to peer review and publication;
(3) what is its known error rate;
(4) are there standards and controls maintained for the technique and methodology; and
(5) has the theory, technique, methodology, etc., been generally accepted.

These factors, however, are not all inclusive, and subsequently courts have employed a number of other factors. Using the Daubert Court’s factors, a successful challenge can also be made against the OF POCT. The technique has been tested. This article discusses two of them, and the endnotes reference several more. It has been subject to peer review and publication. The results of those tests, however, can be described as inconclusive at best, and at worst, demonstrate that the technique and the methodology used is not scientifically reliable for all of the reasons stated above. This is not only true for the roadside portable testing, but also in the confirmatory GC-MS and LC-MS testing due to the contamination. Of import here is that the error rate in these devices has been shown to be high. In fact, in the Washington study, the testing device was completely abandoned because of a constant error rate. The simple truth of the matter is that these devices are not yet ready to be used in everyday policing or prosecution. Although they show promise from a scientific and policing point of view, they are neither reliable nor scientifically proven to be scientifically acceptable.


Drugged driving enforcement is on the increase and will soon be on par with drunk driving. Law enforcement will be using OFCDs to combat it—even though the technology is not up to the task yet. That said, it is our job as constitutional defenders to constantly hold the government scientifically and legally accountable. To do so, we are obligated to learn and understand both the science and the law, meaning their processes, weaknesses, and strengths. Most importantly, we must always do so with dedication, honor and courage.


1. Interestingly, several of the devices look similar to an over-the-counter pregnancy test. For example, the Oratect® III test shows a blue line to indicate there is an adequate sample, and then a red line appears to indicate the presence of any drugs in the OF.

2. Examples of some of the most common and prevalent devices on the market include: Drugwipe® by Securetec (Ottobrunn, Germany); ORALscreen™ by Avitar (Canton, MA); Cozart RapiScan Oral Fluid; Drug Testing System by Cozart Bioscience, Ltd. (Oxfordshire, U.K.); BIOSENS® Dynamic by Biosensor Applications (Solna, Stockholm); Oratect® III by Branan Medical Corporation (Irvine, CA); and SalivaScreen 5™ by Medimpex United Inc. (Bensalem, PA). This is by no means an exhaustive list but is intended to just give an example of the variety of devices available to the public.

3. For those readers who wish to see a video sample of how the devices work, please visit the Dräger DrugTest® 5000’s YouTube page

4. Fourteen States currently have laws or regulations allowing for onsite oral fluid testing: Alabama, Arizona, Colorado, Indiana, Kansas, Louisiana, Missouri, New York, North Carolina, North Dakota, Ohio, Oregon, South Dakota, and Utah. See StopDUID, (last visited July 9, 2013) (“Our goal is to provide the most recent information on drugged driving policies in the United States. This website tracks research and legislative activity to strengthen DUID laws in all 50 states.”).

5. LAPD deploys drug-detection swab tests at sobriety checkpoints, (Dec. 28, 2013).

6. Phil Rennick, “New Tools for the Detection and Prosecution of the Drugged Driver,” (July 2013) (“The Dräger DT5000 is currently being used at sobriety checkpoints in the City of Los Angeles.”).

7. Dave Paresh, Portable drug test a new addition at New Year’s DUI checkpoints,,0,3004417.story#axzz2pq68IpDT (Dec. 27, 2013).

8. Id.

9. Drugged Driving, supra note 2 (“Americans are all too familiar with the terrible consequences of drunk driving. Working with the Department of Transportation and other Federal agencies, the Office of National Drug Control Policy is taking steps to highlight the growing problem of drugged driving.”).

10. Id.

11. Drug Testing and Drug-involved Driving of Fatally Injured Drivers in the United States: 2005–2009, (last accessed July 3, 2013).

12. Id.

13. Id.

14. Robert L. DuPont, Drugged Driving Research: A White Paper 4 (2011).

15. Id.

16. Id.

17. Id.

18. Id. at 7 (the strategy also calls for encouraging states to adopt per se drug impairment laws; collecting further data on drugged driving; enhancing prevention of drugged driving by education communities and professionals; and providing increased training for law enforcement on identifying drugged drivers).

19. Id. at 18.

20. Id. at 24.

21. Id. at 48.

22. The Frye standard is still followed in: California, Illinois, Kansas, Maryland, Minnesota, New Jersey, New York, Pennsylvania, and Washington.

23. Frye v. United States, 293 F. 1013, 1014 (App. D.C. 1923).

24. Tom Blencowe et. al., eds., Analytical Evaluation of Oral Fluid Screening Devices and Preceding Selection Procedures, Druid-Project (March 30, 2010),

25. Id.

26. Jayne E. Thatcher, ROSITA II Project: Evaluation of On-Site Saliva Drug Testing Devices in Washington State, (2007),

27. There is also a study done in Missouri. The Missouri study looked exclusively at the Dräger DrugTest® 5000. The results of that study are available at

28. R. K. Jones et. al., State of Knowledge of Drug-Impaired Driving, The National Highway Traffic Safety Administration (August 2003),

29. Id.

30. Id.

31. See Olaf H. Drummer, Drug Testing in Oral Fluid, 27 Clinical Biochemist Rev. 147 (2006) (concluding “More research is needed to further the detection of drugs present in [OF] which should allow improved reliability of detection of drugs. Similarly, future technological developments of on-site devices should allow more sensitive and reliable detection of a number of drugs.”); K. Wolff et. al., Driving Under the Influence of Drugs: Report from the Expert Panel on Drug Driving, (March 2013), (“Currently, oral fluid tests cannot be used to give a precise prediction of the concentration of a drug in blood (or plasma or serum) for confirmation testing and therefore prediction of possible drug effects.”); Wendy M. Bosker & Marilyn A. Huestis, Oral Fluid Testing for Drugs of Abuse, 55 Clinical Chemistry 1910 (2009) (“The promise of worldwide OF testing spurred commercial research and development of POCT devices, and commercial devices were rushed to market before much of the basic science of drug excretion into OF was known . . . The major problems with early generation OF POCT included inadequate limits of detection, specificity, and efficiency.” Additional research has led to some improved products. However, “additional research is critically needed to characterize potential problems with OF collection devices and immunological and chromatographic assays.”); Marilyn A. Huestis, Oral Fluid Testing: Promises and Pitfalls, 57 Clinical Chemistry 805 (2011) (OF limitations include difficulty of collection following recent drug use and the potential for passive contamination; the following technical issues with OF must be resolved: inconsistent oral fluid and elution buffer volume, variable drug recoveries, inadequate oral fluid immunoassay sensitivity and specificity, and lack of homogeneous immunoassays for automated analyzers; there could be inadequate specimen for multiple drug confirmations); F. M. Wylie et. al., Drugs in Oral Fluid: Part II Investigation of Drugs in Drivers, 150 Forensic Sci. Int’l 199 (2005) (At present, no OF device has the sensitivity or specificity to successfully detect an extensive range of drugs).


*Dräger DrugTest® 5000 is a registered trademark of Drager Safety AD & CO. KGAA Corporation.

*Enzyme Immunoassay (EIA)/Enzyme-Linked Immunosorbent Assay (ELISA) Rudolf M. Lequin Clinical Chemistry

**Analyte—The substance being analyzed in an analytical procedure. In this case it would be a drug such as marijuana, a benzodiazepine, cocaine, etc.

Antibody—Proteins in the body that are designed to target and attack foreign substances that are harmful to the body, substances such as bacteria or viruses.

Portable Breath Testers: A Potentially Dangerous Non-Specific and Non-Selective Measure at Roadside

The history of alcoholic beverages can be traced to the Neolithic period (ca. 10,000 B.C.), shortly after the agricultural revolution.1 Even though alcohol’s impairing effects have long been known, its adverse consequences when combined with travel were not publicly condemned until the invention of the steam train locomotive.2 After the First World War, there was a dramatic rise in motor transportation that brought to the public’s attention the role alcohol could play in accidents on the roadways.3 This focus led to an outcry for legislative punishments for “drunk drivers.”4 In 1939, Indiana and Maine became the first states to criminalize Driving Under the Influence.5 These events spotlighted the need for a reliable way for testing a person for intoxication.6

Alcohol most affects the central nervous system.7 Cognitive functioning and psychomotor functioning changes caused by alcohol are rooted in this system.8 Because blood transports alcohol to the brain and affects the central nervous system, blood was first considered as a source for testing for alcohol concentration and in turn what is thought to be a useful convention to try to correlate a numerical value to a diminished ability to operate a motor vehicle safely.9

In 1927, Emil Bogen became the first person to propose using breath analysis as a means to test for blood alcohol content.10 Breath testing soon became more popular than blood testing because of its noninvasive nature, its quick result, and its ease of use by police.11 When the driver of a stopped vehicle is suspected to be under the influence of alcohol, the officers will retrieve the PBT device from their vehicle and have the driver submit to a test. It is the authors’ experience that the average time from stop to arrest is 7 to 9 minutes. Often the person is stopped near the location where they had recently consumed alcohol.

Today, many police officers carry devices for roadside testing of individuals for alcohol12 concentration in their vehicles. The use of these devices is growing in popularity every day across the country, so much so that they are even popularly offered in retail stores. These devices are called “portable breath testers,” “preliminary breath testers,” “pre-arrest breath test” (PBTs), or “passive alcohol sensors” (PASs). For purposes of this article, we will refer singularly to this family of devices as PBTs.

It is because of the increased use and popularity of PBTs that we need to understand how police devices work to determine if they are used correctly or incorrectly.

There are two technologies and two chemical processes of action that govern PBTs: fuel cell devices and Taguchi gas sensor devices.13

Although the fuel cell was invented in the early 1800s, it was not applied to breath alcohol detection until the 1960s.14 A fuel cell, which consists of two platinum-coated conduction electrodes separated by an ion-conducting electrolyte layer, is designed to convert a fuel and an oxidant into direct current. PBTs use alcohol as the fuel and oxygen from the air as the oxidant.15 Alcohol is oxidized into acetic acid inside the fuel cell.16 This oxidation produces two electrons for each molecule of alcohol.17 In turn, these electrons produce an electrical current that is converted to a BAC and reported by the PBT.18

Exhaling human breath is a continuous input into the machine. Yet, any machine can only report a digital signal as reported on the LED screen. This quantitation with an analog-to-digital signal translation is set based upon a dose-response curve constructed by using a wet bath calibrator that uses a partition ratio of 2100:1 derived from assuming that Henry’s Law applies to the lungs. The human lung is not a closed system. Human breath is not exhaled at a constant temperature or flow or pressure. Therefore, Henry’s Law does not apply. Taguchi gas sensors are small porous stannic oxide semiconductor elements. Alcohol in the breath is attracted to the sensor. This attraction increases the sensor’s electrical conductivity. Increasing the sensor’s conductivity increases the electricity flowing through the sensor. Just like with the fuel cell, the greater the electricity flows, the higher the alcohol reading becomes.19 Of the two methods, the fuel cell has all but replaced this device in PBTs, and therefore, we will only discuss that method in any detail.

The Problems of Fuel Cell Devices

1.1. Lack of Specificity20 for Ethanol

As PBTs are used for purportedly forensic purposes, their specificity for ethanol becomes a critical factor. The electrochemical detector is not specific for ethanol.21 Indeed, there is “much evidence to show” they are actually not specific for ethanol.22 Garriott’s Medicolegal Aspects of Alcohol lists methanol, isopropanol, n-propanol, and acetaldehyde as other alcohols that fuel cells can respond to in addition to ethanol.23 Other studies have also found fuel cells reacting to substances other than ethanol.24

A. W. Jones, PhD, a renowned toxicologist, reports that fuel cells will respond to compounds that contain the hydroxyl group, other than ethanol.25 In a later study, Jones again found that the fuel cell is not specific to ethanol and that other alcohols and aldehydes will also oxidize in the fuel cell.26 This is important because it has been found that in the alcohol family there are over 1,500 chemical compounds that are not found in alcoholic beverages.27 Moreover, it is claimed that ketones such as acetone are not detected by the fuel cell as they are with infrared devices.28 Interestingly, there is at least one documented case where a driver has tested over the legal limit for ethanol, due to acetone, when the driver had no ethanol in his system.29 The fuel cell device used on the stop had falsely reported isopropanol as ethanol.30 The individual had latent diabetes and had been fasting, causing acetone to be present in his system, which his body in turn reduced to isopropanol, resulting in a true false positive.31

In addition, there are documented cases of methanol being mistakenly reported as ethanol by fuel cell devices.32 Absent chromatographic separation, which PBTs do not employ, distinguishing ethanol from methanol is an extremely difficult task,33 if not an impossible one. Of import is that when a PBT detects ketones and hydrocarbons, it can mistakenly report them as ethanol and add to the breath alcohol concentration.

Further proof of the apocryphal nature of the manufacturers’ claims that these devices will not react to anything other than alcohol is documented on YouTube by one of the authors of this paper, Justin J. McShane, F-AIC, JD. The recording shows a .046 g/210L breath reading on an Intoximeters FST PBT, while free of ethanol and eating ordinary white bread.34 In addition to white bread, there are other cases of a fuel cell device falsely reporting milk, soda pop, and cigarette smoke as ethanol.35 Toothpaste (specifically Sensodyne) that contains Sorbitol, a type of alcohol, registers as ethanol on a fuel cell device.36 This has been independently verified in testing by the Boston Herald.37

Another source of Ethanol is by sugar fermentation. This process has been found to occur naturally in the human body when yeast from breads and carbohydrates are present.38 Informal tests at DWI/DUI seminars across the United States have shown results over the legal limit (0.08 g/210L of breath) merely by chewing pizza, bread, or hot dog buns.39 Common foods and drinks have even been found to contain alcohol. Diet 7-Up contains some small amounts of ethanol, and high-energy drinks such as Monster and 180 Energy contain several times more ethanol than Diet 7-Up.40 Breads, pizza, English muffins, wheat bread, and apple walnut rolls have all been found to contain both yeast and ethanol.41 See the endnotes for tables containing more detailed information about the alcohol content of various soft drinks and baked goods, and other beverages.42

1.2. Residual Mouth Alcohol (RMA)

As discussed earlier, alcohol only affects the body once it is transported to the brain by the blood. The PBT and its method assume that the breath sample and source of ethanol comes only from the deep lung or alveolar air.43 A second assumption is that there is no residual mouth alcohol (RMA). As such, we citizens interested in science must be concerned with the validity of these assumptions when testing breath samples. For there to be any measure of the true value, these key assumptions are required to be accurate.44

With the above in mind, it is well known that after drinking an alcoholic beverage, the body retains alcohol in the mucosal lining of the mouth for some time.45 When breath makes contact with mouth alcohol, then the alcohol reading will be falsely ele­vated,46 fantastically so at times. Sources of mouth alcohol include recent ingestion of an alcoholic drink, regurgitation of stomach contents, eructation of stomach gases, Gastroesophageal Reflux (GER), Gastroesophageal Reflux Disease (GERD), Laryngoesophageal Reflux (LER), Laryngopharyngeal Reflux (LPR), and use of breath freshening items.47

PBTs are not designed with RMA safeguards. They do not contain slope detectors48 that would help in detecting RMA.49 Most importantly, when RMA is present, it only works one way: against the defendant, creating a falsely high ethanol content reading.50 Therefore, without these protections, PBTs have no way of distinguishing alveolar air from an inaccurate false high reading caused by any other source. One study found that it might take up to 19 minutes for RMA dissipation.51 The same study cited another source that stood for the possibility of effects lasting for up to one hour after consumption.52

This is why deprivation/observation periods are mandated in full Evidentiary Breath Testing (EBT) schemes like the Intoxilyzer 5000 EN. Yet, at roadside, there is no such requirement. Therefore, it is best practice that a suitable deprivation/observation period be conducted at roadside to ensure the subject’s sample is only deep lung air.53 Further, it would be best practice for the officer to conduct a replicate analysis after another deprivation period to further give confidence to a PBT estimate.54

1.3. Other Factors

Carry Over: Carry over is a potential problem where a portion of a previous breath specimen remains in the PBT and is added to a subsequent estimate. As the National Highway Traffic Safety Administration has cautioned, if the air temperature is low enough, it is possible for carry over to occur in that one person’s sample remains in the PBT and carries over to the next person’s test.55 It is not difficult to see the problems this could cause when the PBT is being used on many drivers, one after another. An example of where this could be a problem is in a roadblock situation where multiple drivers are being tested or in an underage drinking event.

Radio Frequency Interference: PBTs do not have detectors to guard against interference caused by radio frequencies (RFI).56 Here, it is important to note that in Texas, EBT devices, like the Intoxilyzer 5000 EN, are required to have RFI detectors by the Texas Department of Public Safety Breath Alcohol Testing program. Absent an RFI detector, an officer will not know when RFI interference occurs because electric fields are not detectable by the five human senses.57 One manufacturer even cautions officers to avoid “environments with high levels of radio interference or magnetic fields.”58 For the patrol officer, there are plenty of sources of RFI—e.g., hand-held and vehicle mounted radio transmitters, cell phones, CB radios, light bars, in-car video, computer terminals with internet link inside the patrol vehicle, and police radar.59

Independent Sources of Variation: These include the traditional metrological concerns of calibration and bias of the device itself, and variations in taking of the breath sample: temperature fluctuations, physiological differences of individuals, and phase of ethanol metabolism to name a few.60 Most police agencies do not perform routine or preventive calibration or verification checks for these PBTs during the entire period of their deployment in the field. If the police agencies do perform calibration or verification checks, the efforts are typically not validated or well designed.

2. Texas Law

Texas law requires that analysis of a breath sample, to determine a BAC, must be performed according to methods approved by the Texas Department of Public Safety (DPS). Texas Administrative Code establishes the Office of Scientific Director to administer the regulations and qualifications for breath testing and for use as evidence in court cases. Accordingly, the state director evaluates breath test instruments to determine which instruments are approved devices for forensic breath alcohol testing and for use as evidence in court cases. Devices that meet the state director’s approval are placed on a list of approved instruments, which is maintained by DPS.61 This list contains all breath test instruments approved and certified for breath testing in the state in compliance with rules of the Texas Breath Alcohol Testing Regulations.62

There are no approved PBT devices on the DPS list.63 DPS also maintains a list of approved reference sample devices. Again, there are no approved reference sample devices for any PBT device.64 Therefore, PBT results are not admissible to establish any level of impairment or BAC.

Furthermore, attorneys should be familiar with the following Texas cases: Hartman v. State,65 Fernandez v. State,66 and Kelly v. State.67 In Kelly the court adopted a two-prong test for the admissibility of scientific evidence. The court must first determine whether the scientific evidence is sufficiently reliable and then whether it is relevant.68 The court in Kelly adopted three “common sense” criteria that must be met before scientific evidence can be deemed reliable:

a) the underlying scientific theory must be valid;
b) the technique applying the theory must be valid; and
c) the technique must have been properly applied on the occasion in question.69

Hartman recognized the Daubert70 and Kelly test and applied or extended it to all forms of scientific evidence, including breath testing.71

In Fernandez, a wrongly decided case, the court held that PBTs are not certified by DPS, and therefore are only admissible as another form of a field sobriety test and are not admissible for quantitative purposes.72 In other words, they cannot be used to report a specific BAC level, even though many of them will report an amount. Interestingly, the court ignored the Kelly and Hartman requirements. Following the doctrine of stare decisis, Fernandez should have held that PBT evidence is not admissible where the state fails to meet the requirements set forth in Kelly and reaffirmed and further clarified by Hartman.

3. Conclusion

In today’s times, DWI/DUI enforcement is more organized and focused than ever. Everywhere you turn there is a public service announcement promoting strict DWI/DUI enforcement. Whether it is the “Over the Limit, Under Arrest” or the “Drink, Drive, Go to Jail” campaigns or another slogan from a powerful lobbyist and court-watching organization like MADD, DWI/DUI enforcement is serious business. Encouragement and incentives for officers to make DWI/DUI arrests come with serious consequences: false arrests and non-scientific shortcuts. The limitations of commonly used PBTs play directly into the confirmation bias and cognitive bias that exists in DWI/DUI enforcement. Accordingly, it is of utmost importance that we understand and appreciate what PBTs are, how they work, and what they can and cannot do. For when mistakes are made in this field and someone is arrested on an incorrect and false belief they were driving under the influence, it can have large detrimental effects on the person, their family, freedom, liberties, and career that last forever. This, of course, is a greater crime than DWI itself, because we Americans pride ourselves on protecting the innocent. Knowledge and appreciation of the PBT’s limitations must remain constant in order to prevent wrongful arrests and convictions.


1. Bill H. McAnalley, PhD, & Erik H. Aguayo, BS, Chemistry of Alcoholic Beverages, in Medicolegal Aspects of Alcohol 1 (James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

2. Gary W. Kunsman, Human Performance Toxicology, in Principles of Forensic Toxicology 16–19 (Barry Levine ed., 3d ed., AACCPress, 2009).

3. A. W. Jones, Physiological Aspects of Breath-Alcohol Measurement, Vol. 6 No. 2, Alcohol, Drugs and Driving 1–25 (1990).

4. Id.

5. Gary W. Kunsman, Human Performance Toxicology, in Principles of Forensic Toxicology 16–19 (Barry Levine ed., 3d ed., AACCPress, 2009).

6. A. W. Jones, Physiological Aspects of Breath-Alcohol Measurement, Vol. 6 No. 2 Alcohol, Drugs and Driving 1–25 (1990).

7. James C. Garriott, PhD, & Joseph E. Manno, PhD, Pharmacology and Toxicology of Ethyl Alcohol, in Medicolegal Aspects of Alcohol 29 (James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

8. Id.

9. A. W. Jones, Physiological Aspects of Breath-Alcohol Measurement, Vol. 6 No. 2 Alcohol, Drugs and Driving 1–25 (1990).

10. Id.

11. H. W. Bay, K. F. Blurton, H. C. Lieb, & H. G. Oswin, Electrochemical Measurements of Blood Alcohol Levels, Vol. 240 Issue 5375 Nature 52–53 (1972).

12. The term “alcohol” in the criminal justice system is usually assumed to mean the chemical compound “ethyl alcohol” or “ethanol” for it is ethanol that is found in beer, wine, and spirits.

13. Donald J. Ramsell, Preliminary Breath Screening Devices and Their Limitations, in Understanding DUI Scientific Evidence 187–222 (2d ed., Aspatore, 2009).

14. Id.

15. Patrick Harding, BS, & J. Robert Zettl, BS, MPA, Methods for Breath Analysis, in Medicolegal Aspects of Alcohol 241(James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

16. Id.

17. Id.

18. Intoximeters Inc., Fuel Cell Technology, (accessed Jan. 23, 2012).

19. Lawrence Taylor & Steven Oberman, Drunk Driving Defense, 300–304 (6th ed., Aspen Publishers 2006).

20. The International Union of Pure and Applied Chemistry (IUPAC) describes the relationship between Specificity and Selectivity as follows: “A specific reaction or test is one that occurs only with the substance of interest, while a selective reaction or test is one that can occur with other substances but exhibits a degree of preference for the substance of interest. Few reactions are specific, but many ‘exhibit selectivity.’”

21. A. W. Jones, Electrochemical measurement of breath-alcohol concentration: precision and accuracy in relation to blood levels, Vol. 146 Issues 2–3 Clinica Chimica Acta Vol 175–183 (1985); Donald J. Ramsell, Preliminary Breath Screening Devices and Their Limitations, in Understanding DUI Scientific Evidence 187–222 (2d ed., Aspatore, 2009); Thomas E. Workman Jr., Violating the “Alcohol-Free” Probation Requirement—Learning from the Galluccio Matter, Vol. 12 No. 3 Mass. Bar Assoc. Section Review 4–7 (2010).

22. James Nesci, Esq., Defense of Driving Under the Influence Cases, in Medicolegal Aspects of Alcohol 401–408 (James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

23. Patrick Harding, BS, & J. Robert Zettl, BS, MPA, Methods for Breath Analysis, in Medicolegal Aspects of Alcohol 241 (James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

24. A. W. Jones & L. Goldberg, Evaluation of breath alcohol Instruments I. In Vitro Experiments with Alcolmeter Pocket Model, 12 Forensic Science International 1–9 (1978).

25. Id.

26. A. W. Jones, Electrochemical measurement of breath-alcohol concentration: precision and accuracy in relation to blood levels, Vol. 146 Issues 2–3 Clinica Chimica Acta Vol 175–183 (1985).

27. Thomas E. Workman Jr., Violating the “Alcohol-Free” Probation Requirement—Learning from the Galluccio Matter, Vol. 12 No. 3 Mass. Bar Assoc. Section Review 4–7 (2010).

28. A. W. Jones, Electrochemical measurement of breath-alcohol concentration: precision and accuracy in relation to blood levels, Vol. 146 Issues 2–3 Clinica Chimica Acta Vol 175–183 (1985).

29. A. W. Jones, PhD, D.Sc., & L. Andersson, B.Sc., Biotransformation of Acetone to Isopropanol Observed in a Motorist Involved in a Sobriety Check, Vol. 40 No. 4 Journal of Forensic Sciences 686–687 (1995).

30. Id.

31. Id.

32. Alan Wayne Jones, PhD, Observations on the Specificity of Breath-Alcohol Analyzers Used for Clinical and Medicolegal Purposes, Vol. 34 No. 4 Journal of Forensic Sciences 842–47 (1989).

33. Alan Wayne Jones, PhD, Observations on the Specificity of Breath-Alcohol Analyzers Used for Clinical and Medicolegal Purposes, Vol. 34 No. 4 Journal of Forensic Sciences 842–47 (1989).

34. The McShane Firm, LLC, Creating a False PBT Positive with Ordinary Bread, (accessed Jan. 23, 2012).

35. Donald J. Ramsell, Preliminary Breath Screening Devices and Their Limitations, in Understanding DUI Scientific Evidence 187–222 (2d ed., Aspatore, 2009).

36. Thomas E. Workman Jr., Violating the “Alcohol-Free” Probation Requirement—Learning from the Galluccio Matter, Vol. 12 No. 3 Mass. Bar Assoc. Section Review 4–7 (2010).

37. Id.

38. Id.

39. Id.

40. Id.

41. Id.


43. A. W. Jones, PhD, D.Sc., Biochemical and Physiological Research on the Disposition and Fate of Ethanol in the Body, in Medicolegal Aspects of Alcohol115–119 (James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

44. Lawrence Taylor & Steven Oberman, Drunk Driving Defense 303 (6th ed., Aspen Publishers 2006).

45. Barry K. Logan & Sandra Distefano, Ethanol Content of Various Foods and Soft Drinks and their Potential for Interference with a Breath-Alcohol Test, Vol. 22 Journal of Analytical Toxicology (1998).

46. Dr. Donald C. Denney & Dr. Paul M. Williams, Mouth Alcohol: Some Theoretical and Practical Considerations, Alcohol, drugs and traffic safety T86 (1987).

47. See Dr. Donald C. Denney & Dr. Paul M. Williams, Mouth Alcohol: Some Theoretical and Practical Considerations, Alcohol, drugs and traffic safety T86 (1987); Rod G. Gullberg, The Elimination Rate of Mouth Alcohol: Mathematical Modeling and Implications in Breath Alcohol Analysis, Vol. 37 No. 5 Journal of Forensic Sciences, JFSCA, 1363–1372 (1992).

48. A “Slope Detector” is a script written into the source code that evaluates a breath sample as it enters the machine. The script monitors the slope of the graph of ethanol in the subject’s sample. If the slope does not remain within the parameters programmed into the code, then the machine is supposed to flag the sample as RMA and terminate the test.

49. Donald J. Ramsell, Preliminary Breath Screening Devices and Their Limitations, in Understanding DUI Scientific Evidence 187–222 (2d ed., Aspatore, 2009).

50. James Nesci, Esq. Defense of Driving Under the Influence Cases, in Medicolegal Aspects of Alcohol 401 (James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

51. Glenn R. Caddy, Mark B. Sobell, & Linda C. Sobell, Alcohol breath tests: Criterion times for avoiding contamination by “mouth alcohol,” Vol 10(5) Behavior Research Methods & Instrumentation 814–18 (1978).

52. Id.

53. Rod G. Gullberg, The Elimination Rate of Mouth Alcohol: Mathematical Modeling and Implications in Breath Alcohol Analysis, Vol. 37 No. 5 Journal of Forensic Sciences 1363–1372 (1992).

54. Id.

55. Special Testing for Possible Carry Over Effects Using Intoximeters Inc. Alco Sensor IV at 10 Degrees Centigrade, DOT HS 809 424 (U.S. Dept. of Transp., N.H.T.S.A., 2002); James Nesci, Esq. Defense of Driving Under the Influence Cases, in Medicolegal Aspects of Alcohol 401–405 (James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

56. James Nesci, Esq. Defense of Driving Under the Influence Cases, in Medicolegal Aspects of Alcohol 401–405 (James C. Garriott ed., 5th. ed., Lawyers & Judges Publishing Company, Inc., 2008).

57. Effects of Electromagnetic Fields on Evidential Breath Testers, Rpt. (Natl. Bureau of Standards, Electromagnetic Fields Division).

58. Intoximeters, Inc. Alco-Sensor FST Operators Manual (June 2007).

59. See Intoximeters, Inc. Alco-Sensor FST Operators Manual (June 2007); Alcohol breath analyzers and radiofrequency interferences, 16 Int. J. Bio-Medical Computing 3–8 (1985).

60. A. W. Jones, Evaluation of Breath Alcohol Instruments II. In Vivo Experiments with Alcolmeter Pocket Model, 12 Forensic Science International 11–23 (1978).

61. Texas Department of Public Safety, Breath Alcohol Testing Overview, (accessed Jan. 24, 2012).

62. Texas Department of Public Safety Breath Alcohol Testing Bureau, Certified Breath Test Instruments Revised February 23, 2007, (accessed Jan. 24, 2012).

63. Id.

64. Texas Department of Public Safety Breath Alcohol Laboratory, Approved Reference Sample Device List Revised June 10, 2010, (accessed Jan. 24, 2012).

65. 946 S.W.2d 60 (Tex. Crim. App. 1997) (en banc).

66. 915 S.W.2d 572 (Tex. App. San Antonio 1996).

67. 824 S.W.2d 568 (Tex. Crim App. 1992) (en banc).

68. Kelly at 572.

69. Kelly at 573.

70. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

71. Hartman at 60.

72. Fernandez at 572.