, 112117 INAGO, AGO 2017-7

Case DateNovember 21, 2017
CourtIndiana
AGO 2017-7
Official Opinion 2017-7
Indiana Attorney General Opinion
State of Indiana Office of the Attorney General
November 21, 2017
         RE: Cannabidiol & HEA 1148          EXECUTIVE SUMMARY          The Office of the Indiana Attorney General provides this opinion and information for the public regarding whether it is lawful to sell, use or possess products containing a chemical compound commonly known as cannabidiol.          "CBD" is the scientific abbreviation for a chemical compound known as "Cannabidiol" ("cann-uh-bid-DYE-all"). Cannabidiol is one of the more prevalent chemical compounds in the Cannabis (or Marijuana) plant. The chemical compounds that bind together in an array that constitute cannabidiol are defined as "2-(6-isopropenyl-3-methyl-2-cyclohexen-l~yl)-5~pentyl-1,3-benzenediol."1          As a matter of legal interpretation, products or substances marketed for human consumption or ingestion, and containing cannabidiol, remain unlawful in Indiana, and under federal law.2          The state and federal laws that place cannabidiol in the category of a Schedule I controlled substance do not hinge on the degree or prevalence of the pharmacological effects of a substance on a person, for those effects vary from person to person, substance to substance, and component to component. Simply put, cannabidiol is a Schedule I controlled substance because marijuana (Cannabis saliva) is a Schedule I controlled substance. Although it is a relatively new phenomenon, after thoroughly tracking the language of the Indiana law defining "marijuana," it is evident that cannabidiol is now and historically has been derived from "a part of the plant genus Cannabis."3 Scientific literature confirms that cannabidiol simply cannot be distilled in sufficient amounts from any of the inert parts of the plant (such as the "mature stalks of the plant" or the "sterilized seeds of the plant"), Ind. Code 35-48-l-19(b), which are specifically excluded from the basic description of what constitutes "marijuana" according to both state and federal authorities alike.4 Thus, experts and federal authorities are in agreement that mature stalks, sterilized seeds, and other exempt components of the Cannabis plant are insufficient for the manufacture of cannabidiol.5 With that being the case, it is also clear that the parts of the plant being used to manufacture cannabidiol will necessarily include the floral bracts, resin, and leaves of the Cannabis plant.6          This same analysis has been applied by federal authorities operating under the federal Controlled Substances Act, pursuant to guidance put out by the United States Drug Enforcement Administration ("DEA"), and known as "the Extract Rule."7 Read together, these definitions under Indiana law clearly establish that a "substance containing cannabidiol," being extracted from the resinous (non-inert, non-exempt) parts of the plant genus Cannabis, is "marijuana" and is a Schedule I controlled substance.          Cannabidiol is likely to contain some amount of other cannabinoids (i.e., another basic molecular building-block of Cannabis) such as "Tetrahydrocannabinol," which is better known as "THC."8 THC is known to science and the courts as the key cannabinoid found in marijuana. THC is also the key compound known to produce the euphoric, passive, intoxicated or hallucinogenic state sought after by many who consume marijuana.          Under Indiana law, a "substance containing cannabidiol" is defined to contain a certain amount of cannabidiol (at least 5% by weight) and an amount of THC (not more than 0.3% by weight).9 Under Indiana law, THC, including that found in the "resinous extractives of Cannabis," is itself a Schedule I controlled substance.[10] Accordingly, any substance containing cannabidiol is prohibited in Indiana as it falls under the definition of "marijuana" and contains THC, both of which result in it being a Schedule I controlled substance.          In 2017, House Enrolled Act 1148 established a limited and focused exception for possession and use of substances containing cannabidiol by patients and caregivers battling a diagnosis of juvenile or adult treatment-resistant epilepsy.11 According to this legislation, despite the threshold consideration that substances containing cannabidiol retain their prohibition as Schedule I controlled substances, a limited affirmative defense is available. Under this legislatively-created defense, the law makes clear that the burden of proof is on the defendant to show that he qualifies, if he can show that he was properly registered under Indiana's newly created Indiana State Department of Health Cannabidiol Registry ("the Registry").          The existence of the Registry reaffirms that absent this narrowly-focused affirmative defense, substances containing cannabidiol are Schedule I controlled substances, and if identified or so labeled in plain view of a law enforcement officer, are subject to seizure. Individuals possessing or using such substances are subject to prosecution under both state and federal law, barring proof being shown that they qualified for the Registry defense, which under HEA 1148 is limited to those who are battling treatment-resistant epilepsy or their caregivers. Despite the existence of this affirmative defense under HEA 1148, which addresses a kind of medical use and possession by registered, qualified individuals, the Indiana legislature has not yet addressed the distribution or sale of this product. At present, then, no one in Indiana is authorized to commercially distribute or sell CBD or substances containing CBD.          One additional exception allows for limited possession and even cultivation of marijuana under certain narrowly-prescribed circumstances, and that is Indiana's exclusion of "industrial hemp" from its definition of marijuana. On March 26, 2014, Indiana's Industrial Hemp Law ("IHL") was signed by the Governor, and became effective. The IHL classifies industrial hemp as an agricultural product and authorizes the Indiana State Seed Commissioner to pursue the necessary federal permits allowing for the production of, possession of, scientific study of, and limited commerce of industrial hemp. The IHL attempts to make available to Indiana producers the opportunities to cultivate and study industrial hemp afforded by the federal 2014 Farm Bill.12The federal 2014 Farm Bill created an exception to the federal CSA for the limited growth, cultivation and marketing research experimentation with industrial hemp by an institution of higher education or a State department of agriculture if such activities are conducted within federal legal boundaries.          On August 12, 2016, the United States Department of Agriculture ("USDA"), in consultation with the DEA and the United States Food and Drug Administration ("FDA") published a Statement of Principles on Industrial Hemp ("Statement of Principles") in the Federal Register to inform the public about how Federal law applies to activities associated with industrial hemp. The Statement of Principles reiterates that Section 7606 did not remove industrial hemp from the controlled substances list.          In a statement to the public,13 the DEA further advised that it considers Section 7606 to authorize institutions of higher education and state departments of agriculture to grow and cultivate industrial hemp as defined under the 2014 Farm Bill; however, it does not permit such entities, or anyone else, to produce approved drug products subject to FDA approval for human consumption that are made from Cannabis. This is a direct example of a joint affirmation of federal policy, promulgated by three separate federal agencies, affirming that no industrial hemp pilot program, state or federal, is intended to encompass products for immediate human consumption as food, food supplement, or a drug.          Upon careful study and deliberation, it is the opinion of the Indiana Attorney General that the purchase, possession, use and sale of cannabidiol, and substances, food products or edible oils containing cannabidiol are unlawful under both Indiana and federal law. HEA 1148, as it was intended by the Indiana General Assembly, established a limited affirmative defense for the express purpose of treating those with treatment resistant epilepsy.          BACKGROUND          On April 26, 2017, the Honorable Governor Eric J. Holcomb signed HEA 114814 (codified at Ind. Code § 16-42-28.6 et seq) into law, which permits the legal use of a substance containing cannabidiol for the treatment of epilepsy under limited conditions.15 Under the new law, the Indiana State Department of Health ("ISDH") is authorized to develop and implement a cannabidiol...

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