Congressional Representatives Introduce Controlled Substance Analog Legislation to Weed Out Synthetic Drug Manufacturing, Distribution and Sales

September 23, 2015

By Karla L. Palmer – 

Last week, several congressional representatives announced the introduction of H.R. 3537, the “Synthetic Drug Control Act of 2015.”  If enacted, the Synthetic Drug Control Act would strengthen existing federal law (specifically, the Controlled Substances Analogue Enforcement Act) (“Analogue Act”), which provides that any compound that is chemically or pharmacologically similar to a controlled substance in Schedule I or II under the Controlled Substances Act (“CSA”) must be treated as if it is controlled in that same schedule.   

The significant limitation found in the Analogue Act, which the legislators hope to address with passage of the proposed legislation, is that the Analogue Act currently addresses substances that are substantially structurally and pharmacologically similar to a controlled substance as long as they are intended for human consumption.  (21 U.S.C. § 816 (a “controlled substance analogue shall, to the extent intended for human consumption, be treated, for purposes of any Federal law as a controlled substance in Schedule I.”))  Schedule I substances have a high potential for abuse, have no currently accepted medical use in treatment in the U.S. and there is a lack of accepted safety for their use under medical supervision.  21 U.S.C. § 812(b)(1).  The use of newly derived analogues, which crop up on a very regular basis and include “flakka” and “molly,” are often sold legally in colorful, readily identifiable, and branded packaging. These drugs are distributed by convenience stores, head shops, or online, and, importantly, they typically bear the legal fig leaf ‘not for human consumption’ to avoid regulation by the federal Food and Drug Administration.

The legislation intends to facilitate the prosecution of synthetic drug manufacturers and distributors and make Analogue Act law a more useful tool for law enforcement.  It adds to the end of 21 U.S.C. § 813, which currently states “A controlled substance analogue shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I” the following language: “for purposes of prohibitions, restrictions, and other requirements with respect to manufacture, importation, distribution, and sale.” The bill also removes all references of the term “substantially” from the definition of a controlled substance analogue (21 U.S.C. § 802(32)(A), so that substances may be more readily classified as an analogue without having to show that they have a substantial similarity to their alleged counterpart.  Finally, it adds a detailed and long list of known synthetic drugs identified by the DEA into schedule I, thus bypassing the need for DEA to temporarily place substances in Schedule I on an emergency basis and await scheduling by DEA.  Note that at least one court has noted that the Analogue Act as applied is unconstitutionally vague.  See United States v. Forbes, 806 F. Supp. 232, 234 (D. Colo. 1992).     

To ensure that the legislation targets manufacturers and distributors rather than end users, the Synthetic Drug Control Act narrows the Analogue Act to provide that it should apply to the sale, manufacture, import, and distribution of drugs – not simple possession.  A concern likely remains here, however, because the legislation does not address another loophole in the Analogue Act – the fact that synthetic compounds often are not sold as drugs or “for human consumption,” but are instead sold as non-food products (i.e., bath salts) not intended for human consumption and thus elude a clear FDA regulatory status.  Whether the supplier of the product or substance is a manufacturer, distributor, or end user, the fact that the Analogue Act applies to products for human consumption (and the burden is on law enforcement to demonstrate that the suspect product is intended for human consumption) will likely still be an availing loophole throughout the distribution chain.  One other way to close this loophole is to remove the requirement “intended for human consumption” from Section 813.      

Congressman Jim Himes (CT) made the following statement concerning the importance of this legislation:

Synthetic drugs are being marketed in convenience stores and other markets as a safe, legal alternative to controlled substances . . . . This is far from the truth. Without any serious regulation or enforcement, the manufacturers of these drugs are exploiting a legal loophole to put untested, potentially dangerous drugs on the street, where the people buying them have no idea what sort of effect they’re going to have. The side effects can include aggression, disorientation and hallucination, which can lead to harm for the user and others. We need them off the street.