	Background on Synthetic and Designer Drugs

Synthetic drugs, as opposed to natural drugs, are chemically produced in a laboratory. Their chemical structure can be either identical to or different from naturally occurring drugs, and their effects are designed to mimic or even enhance those of natural drugs. When produced clandestinely, they are not typically controlled pharmaceutical substances intended for legitimate medical use. Designer drugs are a form of synthetic drugs. They slightly modify the molecular structures of illegal or controlled substances to circumvent existing drug laws. Concern over the reported increase in use of certain synthetic cannabinoids and stimulants led some to call on Congress to legislatively schedule specific substances. This is, in part, because congressional action could place certain substances onto Schedule I of the Controlled Substances Act (CSA) more quickly than might occur through administrative scheduling actions by the Attorney General and Secretary of the Department of Health and Human Services (HHS), as authorized by the CSA. In June 2012, Congress passed the Synthetic Drug Abuse Prevention Act of 2012—Subtitle D of Title XI of the Food and Drug Administration Safety and Innovation Act ( P.L. Under this law, a controlled substance analogue is defined as a substance if
(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. In May 2013, the DEA placed three synthetic cannabinoids on the list of controlled substances under Schedule I of the CSA. Law enforcement and policymakers—at both the state and federal levels—have taken an interest in and responded to the increasing use of certain synthetic cannabinoids and stimulants. The United Nations Office on Drugs and Crime reported the global emergence of certain synthetic cathinones and cannabinoids from 2009 to 2011. As shown in Figure 1 , these calls decreased from 2011 to 2013, but have risen again over the last two years. The Monitoring the Future (MTF) survey first reported on the rise in synthetic cannabinoid use in its 2011 survey. In June 2012, Congress passed legislation to permanently schedule these five synthetic cannabinoids (and other synthetic substances). Since enactment of the Synthetic Drug Abuse Prevention Act of 2012, the DEA has temporarily placed 10 additional synthetic cannabinoids on Schedule I. Pursuant to the temporary scheduling authority, as expanded under the Synthetic Drug Abuse Prevention Act of 2012 ( P.L. This number climbed to 6,137 calls in 2011 and has declined each year since 2011. In 2015, there were 520 reported calls to poison control centers about exposure to bath salts. Then in April 2013, then-Attorney General Holder—through the DEA and in consultation with the Secretary of HHS—took administrative action to permanently place methylone on Schedule I of the CSA. Notably, all 50 states have banned chemical substances contained in synthetic stimulants such as bath salts. 112-144 ). Under this act, a cannabimimetic agent is defined as one of five structural classes of synthetic cannabinoids (and their analogues). Issues

Congress may confront several issues when considering whether to schedule certain synthetic substances. These issues include potential implications on the federal criminal justice system, the influence of research on scheduling, possible effects of scheduling on future medical research, and the ability to use the Analogue Enforcement Act to enforce drug laws for synthetic substances of concern. Congress may consider whether or not placing certain synthetic drugs on Schedule I will hinder future research on these substances. Options for Congress

In considering enforcement challenges identified by the DEA, Congress may consider a number of options in addressing the continuing sales of synthetic drugs. Congress may amend the CSA in several ways to better facilitate enforcement action against the illicit synthetic drug industry.
Synthetic drugs, as opposed to natural drugs, are chemically produced in a laboratory. Their chemical structure can be either identical to or different from naturally occurring drugs, and their effects are designed to mimic or even enhance those of natural drugs. When produced clandestinely, they are not typically controlled pharmaceutical substances intended for legitimate medical use. Designer drugs are a form of synthetic drugs. They contain slightly modified molecular structures of illegal or controlled substances, and they are modified in order to circumvent existing drug laws. While the issue of synthetic drugs and their abuse is not new, Congress has demonstrated a renewed concern with the issue.
From 2009 to 2011, synthetic drug abuse was reported to have dramatically increased. During this time period, calls to poison control centers for incidents relating to harmful effects of synthetic cannabinoids (such as "K2" and "Spice") and stimulants (such as "bath salts") increased at what some considered to be an alarming rate. The number of hospital emergency department visits involving synthetic cannabinoids more than doubled from 2010 to 2011. In 2012 and 2013, however, the number of calls to poison control centers for incidents relating to harmful effects of synthetic cannabinoids and synthetic stimulants decreased. Calls regarding bath salts have declined each year since 2011, while calls regarding synthetic cannabinoids have increased since the drops in 2012 and 2013. The Monitoring the Future (MTF) survey results from 2015 indicate that annual prevalence rates for use of synthetic cannabinoids are down over the last two years while bath salt use remained low. Government and media reports indicate that fentanyl, a synthetic opioid 50-100 times stronger than morphine, is rising in popularity as well as various synthetic cannabinoids.
The reported harmful effects of synthetic substances range from nausea to drug-induced psychosis. Due to the unpredictable nature of synthetic drugs and of human consumption of these drugs, the true effects of many of these drugs are unknown. Many states have responded to synthetic drug abuse by passing laws banning certain synthetic cannabinoids and stimulants.
In 2011, the Attorney General—through the Drug Enforcement Administration (DEA)—used his temporary scheduling authority to place five synthetic cannabinoids and three synthetic stimulants on Schedule I of the Controlled Substances Act (CSA). Concern over the reported increase in use of certain synthetic cannabinoids and stimulants resulted in legislative action to schedule specific substances. The Synthetic Drug Abuse Prevention Act of 2012—Subtitle D of Title XI of the Food and Drug Administration Safety and Innovation Act (P.L. 112-144)—added five structural classes of substances in synthetic cannabinoids (and their analogues) as well as 11 synthetic stimulants and hallucinogens to Schedule I of the CSA. In addition, the act extended the DEA's authority to temporarily schedule substances. In April 2013, then-Attorney General Holder—through the DEA and in consultation with the Department of Health and Human Services (HHS)—took administrative action to permanently place methylone on Schedule I of the CSA. A number of administrative scheduling actions have since taken place.
In considering permanent placement of synthetic substances on Schedule I of the CSA, there are several issues on which Congress may deliberate. Policymakers may consider the implications on the federal criminal justice system of scheduling certain synthetic substances. Another issue is whether Congress should schedule certain synthetic substances or whether these substances merit Attorney General (in consultation with the Secretary of HHS) scheduling based on qualifications specified in the CSA. Congress may also consider whether placing additional synthetic drugs on Schedule I may hinder future medical research. In addition, policymakers may consider whether it is more efficient to place these drugs on Schedule I of the CSA or to treat them as analogue controlled substances under the Controlled Substances Analogue Enforcement Act. In considering enforcement challenges identified by the DEA, Congress may consider whether to amend the CSA to better facilitate enforcement action against the illicit synthetic drug market.