BILL ANALYSIS Ó SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular Bill No: SB 202 Hearing Date: January 11, 2016 ----------------------------------------------------------------- |Author: |Hernandez | |----------+------------------------------------------------------| |Version: |January 4, 2016 | ----------------------------------------------------------------- ---------------------------------------------------------------- |Urgency: |No |Fiscal: |Yes | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Sarah Mason and Nicole Billington | |: | | ----------------------------------------------------------------- Subject: Controlled substances: Synthetic cannabinoids SUMMARY: Authorizes the California State Board of Pharmacy to include any other substance, in addition to those outlined under current law, as a synthetic cannabinoid compound through the adoption of a regulation. Sets forth various considerations the Board must make in determining if a substance is included as a synthetic cannabinoid compound. Existing law: 1) Establishes the Pharmacy Law which provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board of Pharmacy (Board) within the Department of Consumer Affairs (DCA). (Business and Professions Code § 4000 et seq.) 2) Establishes the California Uniform Controlled Substances Act which regulates controlled substances. (Health and Safety Code (HSC) § 11000 et seq.) 3) Classifies controlled substances in five schedules according to their danger and potential for abuse. (HSC §§ 11054-11058) 4) Provides that every person who sells, dispenses, distributes, furnishes, administers, or gives, or offers to sell, dispense, distribute, furnish, administer, or give, or SB 202 (Hernandez) Page 2 of ? possesses for sale any synthetic cannabinoid compound (SCC), or any synthetic cannabinoid (SC) derivative, to any person, is guilty of a misdemeanor, punishable by imprisonment in a county jail not to exceed six months, or by a fine up to $1,000, or by both that fine and imprisonment. (HSC § 11357.5.) 5) Provides that every person who uses or possesses any SCC, or any SC derivative, is guilty of an infraction, punishable by a fine not to exceed $250. (Id.) 6) Defines SCC, for purposes of the penalties outlined above, as any of the following substances: a) 1-pentyl-3-(1-naphthoyl)indole (JWH-018); b) 1-butyl-3-(1-naphthoyl)indole (JWH-073); c) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200); d) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP-47,497) and ; e) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8 homologue) (Id.) This bill: 1) Authorizes the California State Board of Pharmacy to include any other substance, in addition to those outlined under current law, as a SCC through the adoption of a regulation and authorizes the Board to do so through emergency regulations. Sets forth various considerations the Board must make in determining if a substance is included as a SCC, including: a) The substance's actual or relative potential for abuse; b) Scientific evidence of the substance's pharmacological effect, if known; c) The state of current scientific knowledge regarding the substance; SB 202 (Hernandez) Page 3 of ? d) The substance's history and current pattern of abuse; e) The scope, duration, and significance of abuse of the substance; f) The risk to public health caused by the substance; g) The substance's potential to produce psychological or physiological dependence; h) Whether the substance is an immediate precursor of a substance already included in this subdivision; and, i) The substance's similarity to other substances already considered SCCs. FISCAL EFFECT: Unknown. This bill is keyed fiscal by Legislative Counsel. COMMENTS: 1. Purpose. The Author is the Sponsor of this bill. According to the Author, the dangers of synthetic marijuana have been well documented and multiple horror stories of the effects of these chemicals have been reported in recent years. Synthetic cannabinoids, which refer to a growing number of man-made mind-altering chemicals that are either sprayed on dried, shredded plant material so they can be smoked (herbal incense), or sold as liquids to be vaporized and inhaled in e-cigarettes and other devices (liquid incense), are sometimes misleadingly called "synthetic marijuana" or "fake weed" and marketed as safe, legal alternatives to that drug. The Author states that these chemicals may actually affect the brain much more powerfully than marijuana and that their effects are unpredictable, and in some cases, severe or even life threatening. While existing law bans a certain chemical makeup of synthetic marijuana, the Author is concerned that the manufacturers of synthetic marijuana stay one step ahead of the law by changing the active ingredients in their products, SB 202 (Hernandez) Page 4 of ? thereby keeping the product legal. Given how rapidly different product variations change and the inability of the legislative process to move as quickly to keep up to outlaw the new formulations, the Author believes it is necessary for swifter action to be taken. The adoption of emergency regulations by the Board of Pharmacy to add specific chemicals to the definition of a synthetic cannabinoid compound will ensure that dangerous substances are made illegal so that penalties for selling and distributing these will apply. 2. Background. According the White House Office of National Drug Control Policy, synthetic cannabinoids are the second only to marijuana on the list of most frequently used drug among 12th grade students in the United States. In 2012, one in nine high school seniors reported use of synthetic cannabinoids in the past year. The Centers for Disease Control (CDC) reported that between January and May 2015, poison centers in 48 states reported receiving 3,572 calls related to synthetic cannabinoid use, a 229 percent increase from the 1,085 calls received during the same January through May period in 2014. The 2015 figures included a spike of 1,501 calls in April, and 15 reported deaths, a three-fold increase over the five deaths that were reported in 2014. According to CDC, "The increasing number of synthetic cannabinoid variants available, higher toxicity of new variants, and the potentially increased use as indicated by calls to poison centers might suggest that synthetic cannabinoids pose an emerging public health threat. Multiple other recent outbreaks suggest a need for greater public health surveillance and awareness, targeted public health messaging, and enhanced efforts to remove these products from the market." As the use of synthetic cannabinoids has become increasingly pervasive, regulation has struggled to provide an adequate response. On the federal level, the Controlled Substances Act of 1970 (Act) regulates the manufacture, importation, distribution, possession, and use of certain controlled substances. The Act contains five classifications called "Schedules" with varying qualifications for inclusion in each class. Often considered the most serious, Schedule I controlled substances have a high potential for abuse and no currently accepted use in United States medical treatments. SB 202 (Hernandez) Page 5 of ? Until 2012, synthetic cannabinoids were not permanently covered under the Act. The Controlled Substance Analogue Enforcement Act of 1986 (AEA) allowed a drug not covered under the Act to be treated as a controlled substance if it is chemically and/or pharmacologically similar to a Schedule I or Schedule II controlled substance. However, AEA may only be applied to substances intended for human consumption. Many synthetic cannabinoids are labeled as "not intended for human consumption" in an attempt to circumvent the AEA. Therefore, the AEA has provided only weak authority over many of these substances. The United States Attorney General, in consultation with the federal Drug Enforcement Administration has the authority to temporarily place a substance onto Schedule I of the Act if the substance poses an imminent hazard to public safety. Before the Synthetic Drug Abuse Prevention Act of 2012, the temporary scheduling of a substance could last only one year with a possible six month extension. The Synthetic Drug Abuse Prevention Act, however, extended this temporary scheduling limit to two years, with a one year possible extension. Throughout the past five years, the Attorney General has exercised this authority for many variations of synthetic cannabinoids. The use of temporary scheduling has proved challenging, though, as the formula for synthetic cannabinoids are often shifted and different substances used in order to avoid being captured as a Schedule I substance. Currently, there are two methods by which a substance may be permanently scheduled under the Act. Administratively, substances may be scheduled by the Attorney General in consultation with the Secretary of Health and Human Services. Congress may also schedule substances through legislative action. The 2012 Synthetic Drug Abuse Prevention Act was an example of the latter. In addition to doubling the maximum time period for temporary scheduling, the Synthetic Drug Abuse Prevention Act permanently added five classes of synthetic cannabinoids as Schedule I drugs under the Act. These classes were broad structural categories of synthetic cannabinoids, and therefore provide a more general application of the law. SB 202 (Hernandez) Page 6 of ? 3. Efforts in Other States to Deal with the Dangers of Synthetic Cannabinoids. At the state level, several regulatory approaches have been used. The majority of states have taken legislative action to ban specific versions of synthetic cannabinoids by adding individual substances to the state's controlled substances schedule. However, these specific bans can be ineffective due to the continuously evolving formulas of the products. As a result, some states have moved to general bans that prohibit synthetic drugs by describing only the general chemical makeup and/or by failing to list individual substances. Colorado, for example, defines a "synthetic cannabinoid" as, "any chemical compound that is chemically synthesized and either: (I) Has been demonstrated to have binding activity at one or more cannabinoid receptors; or (II) is a chemical analog or isomer of a compound that has been demonstrated to have binding activity at one or more cannabinoid receptors" (NCSL). Other laws use chemical "classes" to describe groupings of similar drugs. Another method of combating synthetic cannabinoids in a more general manner is via analog laws, which ban drugs of sufficiently similar chemical structure or pharmacological effect as that of a controlled substance. Generally, these laws require that the analog drug be substantially similar in chemical structure and have similar intoxicating (pharmacological) effects as a scheduled controlled substance. According to the National Alliance for Model State Drug Laws, 34 states have analog laws, and a number of states have amended their analog laws to specifically address emerging synthetic substances. Recently, some states have gone further to restrict the labeling, display, and advertising of synthetic cannabinoids through consumer protection laws. Illinois, for example, created criminal penalties for false advertising or misbranding "synthetic drug products." Other states have created civil penalties or are utilizing business licensing and other regulations to sanction businesses that illegally sell these substances. States have also used administrative action by delegating scheduling authority to pharmacy boards or other agencies as a means of quickly banning substances in these products when they are identified. Some state legislatures have authorized SB 202 (Hernandez) Page 7 of ? agencies to pass temporary bans that will then be reviewed and codified by the legislature after a specified period of time, while others have given agency bans the full force and effect of statutory law. For example, in 2012, Minnesota authorized its Board of Pharmacy to use an expedited rule-making process to temporarily add substances to Schedule I. The Minnesota Legislature must subsequently approve these new additions. Alternatively, New York statute authorizes the Commissioner of the Department of Health to make any permanent rules and regulations that further the purpose of the public health code. The Commissioner has banned the manufacture, sale and use of numerous synthetic drugs. 4. Current Related Legislation. SB 139 (Galgiani) makes it an infraction to use or possess specified SC or stimulant drugs and expands the definition of a SCC and SC to include numerous chemical families or classes and a myriad of individual chemicals. ( Status: The bill is currently pending in the Assembly.) 5. Prior Related Legislation. SB 253 (Hueso) of 2013 would have added SC possession, sale or furnishing or being under the influence or selling or arranging the sale of a SC or synthetic stimulant to the offenses for which a pupil can be recommended for suspension or expulsion. The bill also would have expanded penalties for possession of any SC and synthetic stimulant compound or synthetic stimulant derivative and would have expanded the definition of SC for purposes of prohibitions that include additional compounds to those outlined under current law. ( Status: The bill was never heard in a policy committee of the Senate.) SB 1283 (Hernandez, Chapter 372, Statutes of 2013) created an infraction, with a maximum fine of $250, for use and possession of specified SCCs and SC derivatives. SB 420 (Hernandez, Chapter 420, Statutes of 2011) established the provisions under current law that every person who sells, dispenses, distributes, furnishes, administers, or gives, or offers to sell, dispense, distribute, furnish, administer, or give, or possesses for sale any SCC or SC derivative, to any person, is guilty of a misdemeanor punishable by imprisonment in a county jail not exceeding six months, or by a fine not exceeding $1,000, or by both that fine and imprisonment. SB 202 (Hernandez) Page 8 of ? AB 2420 (Hueso) of 2011 was similar to SB 253 above. ( Status: The bill failed passage in the Assembly Committee on Public Safety.) ACR 69 (Hueso, Resolution Chapter 84, Statutes of 2011) urged law enforcement, first responders, schools, local elected officials, and parents to educate youth and raise awareness about the risks associated with synthetic drugs. NOTE: Double-referral to Senate Committee on Public Safety SUPPORT AND OPPOSITION: Support: None on file as of January 6, 2016. Opposition: None on file as of January 6, 2016. -- END --