1. Overview of Current Synthetics Darrell L. Davis Laboratory Director DEA South Central Laboratory Dallas, Texas

2. Objectives Discuss: Spice/K2/Cannabinoid/Bath Salts Discuss DEA Scheduling Procedures

3. SPICE/K2/CANNABINOIDS

4. SPICE Unregulated mixture of dried herbs – Ingredients are commonly listed as “Indian Warrior” and “Wild Dagga” or “Lion’s Tail” “Each of which are potentially bioactive herbs” – No mention of additives or other compounds that have a pharmacological activity

6. What are they?

7. Spice Facts – Street Names Spice Spice Gold Kush Legal Eagle Earth Impact Scope Spice Egypt K2 Sence Yucatan Fire Smoke Gorillaz Skunk Genie Galaxy Gold Space Truckin Solar Flare Moon Rocks Blue Lotus Aroma ChillX Highdi’s Almdrohner

8. Spice Facts Street names: K2 Fake Weed Spice Spice Gold Yucatan Gold Skunk Genie Voodoo Effects: hallucinations severe agitation elevated heart rate elevated blood pressure red eyes mood alteration www.sciencedaily.com

9. A Little Background Synthetic cannabinoids were created in an attempt to manufacture a legitimate pharmaceutical that would produce the pain relieving effects of marijuana without producing the “high.” Compounds are named for whom or where they were synthesized. – JWH-018 – John W. Huffman – HU-210 – Hebrew University

10. History 2004 – “Spice” brand products sold on the internet and Head shops. 2007-2008 – Spice monitoring begins Dec 2008 – Two German labs identify JWH- 018 in Spice products Austria & Switzerland ban herbal incense Jan 2009 – Two German labs and the National Institute of Health Sciences in Japan identify CP 47,497 in seven “Spice” products

11. History Jan 2009 – Germany banned CP 47,497 and JWH-018 Jan 2009 – U.S. Customs and Border Patrol report a “small but verifiable” amount of HU- 210 Feb 2009 – France banned CP 47,497, JWH- 018, and HU-210

12. History Apr 2009 – K2 hits the market Aug 2009 – UK Advisory Council on the Misuse of Drugs advised the government to control some synthetic cannabinoids. Sept 2009 – K2 was reported in schools in the Kansas area. Feb 2010 – The single source of K2 in Lawrence, KS was raided

13. Since then the use of synthetic cannabinoids has spread like wild fire Several states have enacted emergency legislation making it illegal The Federal Government has emergency scheduled JWH-018, JWH-073, JWH-250, & CP 47,497 (C8 also) as of March 1, 2011. HU-210 is already covered under the Federal Analogue Act History

14. How do these drugs work? They work just like marijuana! They bind to chemical receptors (CB 1 ) in the central nervous system designed to bind with natural endocannabinoinds manufactured by your body. – Endocannabinoids are responsible for physiological processes Appetite Mood Memory Pain Sensation These drugs are habit forming and slightly addictive.

15. How much does it cost?

16. How is it used?

17. What now? Making synthetic cannabinoids illegal is problematic – How do we test it? – Which compounds do we make illegal? Will the Controlled Substances Analog Act cover isomers? – Where do we get known chemical standards to compare street drugs to? – How do we testify to something that has yet to be researched?

18. Resources www.drugfree.org Forendex (SAFS) www.drugfree.org www.theantidrug.comCLIC_List www.theantidrug.com www.dare.comSWAFS_List www.dare.com www.fairbankscd.org www.wikipedia.org www.jwh-info.com www.erowid.org www.deadiversion.usdoj.gov/drugs_concern/spi ce/index.html www.deadiversion.usdoj.gov/drugs_concern/spi ce/index.html

19. Bath Salts, What are they? Spice: A never ending story? 3,4-Methylenedioxypyrovalerone (MDPV) is a designer drug of the phenethylamine class. MDPV is structurally related to cathinone, an active alkaloid found in the khat plant, 3,4- methylenedioxymethamphetamine (MDMA), methamphetamine, and other schedule I phenethylamines.

20. Bath Salts, What are they? Spice: A never ending story? MDPV, like some other substances in this class, is a central nervous system (CNS) stimulant. MDPV is also reported to have hallucinogenic effects.

21. Miami 'zombie' attacker may have been using 'bath salts' -- CNN Spice: A never ending story? A naked man who chewed off the face of another man in what is being called a zombie- like attack may have been under the influence of "bath salts," a drug referred to as the new LSD.

22. Types of Scheduling Actions DEA Office of Diversion Control Administrative Formal Legislative Temporary

23. Activities DEA Office of Diversion Control Reports of abuse and seizure data prompts DEA to: – Monitor substances through drug seizure and supply databases – Collect and disseminate scientific information to law enforcement – Evaluate international trends – Coordinate response with other agencies

24. Formal Rulemaking Comments / Hearing ? * * = denotes industry involvement Petition/ Activity DEA Initiates AcceptedRejected YES DHHS* DEA Enforces DEA Review If accepted YES NDA* Submission DHHS Initiates Scheduling recommendation DEA Review* NIDA FDA* Advisory* Committee Domestic Scheduling of Controlled Substances DHHS* Scientific / Medical Evaluation DEA Office of Diversion Control

25. Controlled Substance Act Under the CSA, there are five schedules under which substances may be classified—Schedule I being the most restrictive. Substances placed onto one of the five schedules are evaluated on:

26. Controlled Substance Act actual or relative potential for abuse; known scientific evidence of pharmacological effects; current scientific knowledge of the substance; history and current pattern of abuse; scope, duration, and significance of abuse; risk to public health; psychic or physiological dependence liability; and whether the substance is an immediate precursor of an already-scheduled substance.

27. Emergency Scheduling Before a substance may be placed into emergency scheduling the following factors must be considered: 1)History and Current Pattern of Abuse 2)Scope, Duration, and Significance of Abuse 3)What, if any, Risk to Public Health

28. Emergency Scheduling A substance meeting the statutory requirements for temporary scheduling (21 U.S.C. 811(h)(1)) may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision.

29. Emergency Scheduling DEA Office of Diversion Control As of March 2011 and October 2011 The following were placed as Schedule I Controlled Substances – JWH-018 – JWH-073 – JWH-200 – CP-47,497 – CP-47,497 C8 homologue – Mephedrone – MDPV – Methylone

30. Controlled Substance Analogues DEA Office of Diversion Control The issue of whether a substance is a “controlled substance analogue” is an issue of fact which must be determined by a judge or jury. There are three criteria involved in determining whether a substance is a controlled substance analogue.

31. Controlled Substance Analogues (1) First, the government must present evidence to support a finding that a substance has a chemical structure substantially similar to a Schedule I or II controlled substance. Then the government must present evidence that either

32. Controlled Substance Analogues (2) the substance has a pharmacological effect substantially similar or greater than a Schedule I or II controlled substance or (3) the substance was represented by the seller to have a pharmacological effect substantially similar to or greater than a Schedule I or II controlled substance (example: “this acts just like MDMA”).

33. Current Legislation Several bills have been introduced in the to Congress that confront the issue of synthetic drug use and abuse There is current legislation being proposed that would add 15 cannabimimetic substances and 11 cathinones, etc., to schedule I (26 substances total) of the CSA.

35. Thanks! Darrell.L.Davis@usdoj.gov 972-559-7950 Rashad.A.Sims@usdoj.gov 972-559-7953