Citing Imminent Hazard to Public Safety, DEA Publishes Notice of Intent to Temporarily Places Synthetic Cathinones Into Schedule I of the CSA

September 9, 2011

By Karla L. Palmer & John A. Gilbert

On September 8, 2011, the Drug Enforcement Administration (“DEA”) published a Notice of Intent to temporarily place into Schedule I of the Federal Controlled Substances Act (“CSA”) three synthetic cathinones.  75 Fed. Reg. 55616 (Sept. 8, 2011).  The action is based on a finding by the DEA Administrator that the substances mephedrone (methylcathinone), methylone (3,4-methylenedioxy-N-methylcathinone), and MDPV (3,4-methylenedioxypyrovalerone) are an imminent hazard to the public safety.

As reported here in December 2010 and March 2011, DEA has authority (as delegated by the U.S. Attorney General) to temporarily place a substance into Schedule I of the CSA for a one-year period (subject to a six-month extension) without having to comply with the usual scheduling requirements under 21 U.S.C. § 811(b) if the agency makes a finding that such action necessary to avoid imminent hazard to the public health.  DEA last invoked its temporary scheduling authority in December 2010 when it published a notice of intent to temporarily schedule five synthetic cannabinoids in Schedule I, and finalized that temporary scheduling in March 2011.  Prior to its emergency action concerning synthetic cannabinoids, DEA last invoked its temporary scheduling authority in 2004.

As described in yesterday’s Notice of Intent, in order to temporarily place a substance in Schedule I of the CSA to avoid an imminent hazard to the public safety, the DEA Administrator is required to consider three of the eight factors set forth in 21 U.S.C. § 811(c).  In this case, the Administrator considered the following three factors: (4) the substances’ history and current pattern of abuse; (5) the scope, duration and significance of abuse; and, (6) what, if any, risk each poses to the public health.  DEA explained that  consideration of these factors also “includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution.” (Citing 21 U.S.C. § 811(h)(3)).

With respect to the first factor that the Administrator considered – the abuse history and current pattern of abuse – the pharmacological effects of synthetic cathinones are similar to those of highly abused products such as methamphetamine, cathinone, methcathinone and MDMA.  They cause, among other effects, agitation, tachycardia, dilated pupils, hyperthermia, sweating, and hypertension.  Thus, the abuse of synthetic cathinones is likely similar to those highly abused substances.  The DEA also noted that the three substances identified by DEA in its Notice of Intent represent more than 98% of the reported synthetic cathinones recently seized by law enforcement.

As to the second factor that it considered – the scope, duration and significance of abuse – the DEA cited to the recent emergence of these substances on the U.S. illicit drug market, yet noted that the products have been popular in Europe since 2007.  The three products (marketed as bath salts, plant food, or research chemicals; and labeled “not for human consumption”) are typically sold in smoke shops, head shops, adult book stores,  gas stations, and are routinely purchased via the internet.  The DEA noted that retailers promote that routine drug tests will not detect their presence in the body.  Surveys and other research also indicates that the substances are being widely abused, marketed to teens and young adults, and sold for their psychoactive properties – as alternatives to stimulants like cocaine and MDMA.  The DEA Notice of Intent describes that the methods of administration of the illicit substances include snorting, swallowing, and “bombing” (i.e., wrapping powder in a paper wrapper and swallowing), and are also reported to be used as  “binge” products.

Citing their rampant increase in popularity since these synthetic products appeared on the U.S. drug market scene back in 2009, DEA states that poison control centers have already received 4,137 calls relating to synthetic cathinones in the first seven months of 2011; which is up from the 303 calls received for such substances in all of 2010.  In addition, the U.S. Customs and Border Patrol has encountered at least 96 shipments of synthetic cathinones at one border; most of which originated from India or China and are being shipped throughout the United States.  Due to the potential for abuse, as of July 2011, at least 33 states have emergency scheduled or taken action to control synthetic cathinones.  All members of the European Union have placed controls on the possession or sale of them as well.

As to the required third factor in DEA’s consideration – the risk to the public health — the DEA stated that these substances have been the subject of serious abuse, and are associated with numerous emergency room admissions.  Given the frequent reports of adverse and significant health incidents (including three deaths) associated with the use of these substances, their high potential for abuse, and because there is no acceptable medical use in treatment in the United States for the substances, the DEA found it necessary to provide the requisite 30-day notice that the substances are subject to  expedited temporary scheduling as set forth in 21U.S.C. § 811(h).  The DEA Administrator will issue a final order temporarily scheduling the three substances into Schedule I upon the expiration of the 30-day notice period, or after October 11, 2011.  The temporary scheduling is effective for up to 18 months pending the DEA’s completion of the scheduling process.  After the expiration of the 30-day notice period, MDPV, mephedrone and methylone will be subject to the “regulatory controls and administrative, civil  and criminal sanctions applicable to the manufacture, distribution, possession, importing and exporting of a Schedule I controlled substance under the CSA.”