(in? INDIANA OFFICE OF THE ATTORNEY GENERAL CURTIS T- Hm, JR. 302 IGCS 5TH FLOOR GENERAL INDIANAPOLIS, INDIAN-A 4620/: November 21, 2017 OFFICIAL OPINION 2017?7 RE: Cannabidiol HEA 1148 EXECUTIVE SUMMARY The Of?ce 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. is the scienti?c abbreviation for a chemical compound known as ?Cannabidiol? 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 de?ned as 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 sativa) is a Schedule I controlled substance. Although it is a relatively new phenomenon, after thoroughly tracking the language of the Indiana law de?ning ?marijuana,? it is evident that cannabidiol is now and historically has been derived from ?a part of the plant genus Cannabis.?3 Scientific literature con?rms that cannabidiol simply cannot be distilled in suf?cient 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 which are speci?cally excluded from the basic description of what constitutes ?marijuana? according to both state and Ind. Code 2 This conclusion does not apply to any product that is approved by the FDA. There are currently two products that contain cannabidiol undergoing clinical trials; Epidiolex and Sativex. 3 Ind. Code 35-48-1-l9(a) Page 1 0f14 (3'17) 232-6201 - FAX (317) 232-7979 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 insuf?cient 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 ?oral 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 and known as ?the Extract Rule?? Read together, these de?nitions under Indiana law clearly establish that a ?substance containing cannabidiol,? being extracted from the resinous (non-inert, non~exernpt) 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 another basic molecular building?block of Cannabis) such as ?Tetrahydrocannabinol,? which is better known as 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 de?ned 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 de?nition 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 4 Id; see also H. Molleken H. Hussman, Cannabinoid in seed extracts of Cannabis sativa cultivars, INT. HEMP ASSOC. 73?79 (1997); S. Ross et al., GC-MSAnalysis ofthe Total A9-THC Content of Both Drug? Cannabis Seeds, 24 J. ANAL. TOXIC. 715-717 (2000). 5 DEA Diversion Control Division, Clari?cation offhe New Drug Code 735 0 for Marijuana Extract, available at extract 7350.11tml (last visited November 20, 2017). 6 Id. 7 Establishment of a New Drug Code for Marthaana (sic) Extract, 80 Fed. Reg. 90,194-196 (Dec. 14, 2016), codified at 21 C.F.R. 1308.1 8 There is some dispute among the manufacturers and producers of substances containing cannabidiol products as to whether these products can be produced without containing Under the current state of the law in Indiana, it is not necessary that the substance contain for the substance to be illegal. If it is derived from the ?oral bract or leaves of the plant, regardless of the presence of it is illegal. See Ind. Code 35?43?1-19 (de?nition of ?marijuana? does not require it to contain THC). 9 Ind. Code 10Ind. Code 35?48-2-4. 11 The provisions of HEA 1148 are codi?ed at Ind. Code 16-42?286 et seq. Page 2 of 14 as Schedule I controlled substances, a limited af?rmative 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 quali?es, 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 reaf?rms that absent this narrowly-focused af?rmative defense, substances containing cannabidiol are Schedule I controlled substances, and if identi?ed or so labeled in plain view of a law enforcement of?cer, 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 quali?ed 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 af?rmative defense under HEA 1148, which addresses a kind of medical use and possession by registered, quali?ed 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 GED 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 de?nition of marijuana. On March 26, 2014, Indiana?s Industrial Hemp Law was signed by the Governor, and became effective. The IHL classi?es 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, scienti?c 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.12 The 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 in consultation with the DEA and the United States Food and Drug Administration published a Statement of Principles on IndustriaZ 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 af?rmation 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. 12 See Ind. Code ?15~15~13, et seq. ?3 DEA Statement on CBD, Hemp and ?Farm Bill (Aug. 2015). Page 3 of 14 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 af?rmative 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 (codi?ed at Ind. Code 16-42-286 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 is authorized to develop and implement a cannabidiol registry of patients and caregivers for the use of a substance containing cannabidiol in the treatment of patients who have been diagnosed with treatment?resistant epilepsy.16 Although the provisions of Ind. Code 16-42-286 et seq. allow for the use and possession of a substance containing cannabidiol by properly registered caregivers and patients, the law does not contemplate, or expressly establish, a regulatory scheme allowing for the actual manufacture, distribution, or sale of cannabidiol and substances containing cannabidiol in Indiana. Despite permitting limited use and possession of substances containing cannabidiol by properly registered individuals, the purchasing or otherwise actually obtaining lawful access to substances containing cannabidiol remains highly problematic, and has not been adequately addressed under Indiana law. Currently, Ind. Code 16-42?286 et seq. only describes the limited circumstances under which use and possession of cannabidiol is legal in Indiana. ANALYSIS In Indiana, the primary goal of a court when construing a statute is to ascertain the legislative intent.? ?To discern that intent, [an Indiana court will] look ?rst to the statutory language itself and give effect to the plain and ordinary meaning of statutory terms.?18 Our Indiana Supreme Court summarized the starting point for statutory interpretation as follows: a statute is unambiguous, that is, susceptible to but one meaning, we must give the statute its clear and plain meaning. However, if a statute admits of more than one interpretation, then it is ambiguous; and we thus resort to rules of statutory interpretation so as to give effect to the legislature?s intent.?19 1? House Enrolled Act 1148 15 Ind. Code 16 Ind. Code Under Ind. Code l6?42?28.6?6, ?treatment resistant epilepsy? is de?ned to include: (1) Dravet (2) Lennox-Gastaut or (3) another form of epilepsy in a patient who has not responded to at least two (2) other epilepsy treatment option that have been provided in good faith. 17 Adams 12. State, 960 793, 798 (Ind. 2012). ?3 Pierce v. State, 29 1258, 1265 (Ind. 2015) - ?9 Suggs v. State, 51 1190, 1193m94 (Ind. 2016) (internal citations omitted). Page 4 of 14 The language of HEA 1148, ?rst and foremost, authorizes the limited use and possession of a substance containing cannabidiol by caregivers and patients properly registered with the ISDH.20 In doing so, the legislature enacted an af?rmative defense for possession and use of these substances for properly registered individuals. Accordingly, this permitted use must be understood in the context of existing statutes regulating and prohibiting the use of controlled substances in Indiana, as codi?ed in Ind. Code 35-48-1-2 to Ind. Code 35~48~7~14. The analysis below demonstrates that ?cannabidiol? and ?substance containing cannabidiol? are prohibited by the Indiana Controlled Substances Act with a limited exception for those permitted under HEA 1148. In considering the implications of the Indiana Controlled Substances Act, it is necessary to examine the application of Indiana?s industrial hemp exception as it relates to ?substance containing cannabidiol.? But the analysis cannot stop there. It is also prudent to consider the impact of federal law and regulations concerning marijuana and industrial hemp given the federal government?s authority to enforce the federal Controlled Substances Act (CSA), 21 U.S.C. 801, et seq. I. HEA 1148 Created a Limited Affirmative Defense. Pursuant to Ind. Code 16-42-286-1, ?cannabidiol? is de?ned as Additionally, Ind. Code de?nes ?substance containing cannabidiol? as follows: Ind. Code ?Substance containing cannabidiol? a product that contains: (1) not more than three-tenths percent total tetrahydrocannabinol (THC) by weight, including its precursors and derivatives; (2) at least ?ve percent cannabidiol by weight; and (3) no other controlled substances. Despite Ind. Code 16-42-286 et seq. authorizing the use and possession of a substance containing cannabidiol by caregivers and patients properly registered with the ISDH, it does not exclude these substances from other regulations and classi?cations related to narcotic and nonnarcotic drugs. In fact, HEA 1148 only authorized an af?rmative defense to certain offenses and conditions. In relevant part, HEA 1148 authorized the following af?rmative defense to Ind. Code 35?48?441 (possession of marijuana, hash oil, hashish, or salvia): It is a defense to a prosecution under subsection based on the possession of a substance containing cannabidiol that: the person is a patient or caregiver registered under IC 1642?286 for the use of a substance containing cannabidiol; (2) the person reasonably believed that the substance possessed by the person was a substance containing cannabidiol; and (3) the substance containing cannabidiol is packaged in a container labeled with the origin, volume, and concentration by weight of total THC, including its precursors and derivatives, and cannabidiol.[21] 2? Ind. Code 16?42-286 et seq. 2* Ind. Code 35-48?4-11 Page 5 of 14 As such, it is presumed under Indiana law that anyone claiming to possess these items has an af?rmative duty to prove they are in compliance with the law.22 To the extent that a substance does not satisfy the de?nition of ?cannabidiol? or ?substance containing cannabidiol,? it is not permissible under Ind. Code 16-42-286 ez? seq. and no affirmative defense could be proven. For example, the provisions of Ind. Code 16-42-286 et seq. are not implicated when a Substance contains more than three~tenths percent total Tetrahydrocannabinol (THC) by weight or contains less than ?ve percent cannabidiol by weight. II. Apart from the limited exception in HEA 1148, ?cannabidiol? and ?substance containing cannabidiol? are prohibited by the Indiana Controlled Substances Act. Given that a ?substance containing cannabidiol??as de?ned to include Tetrahydrocannabinolwwould not be excluded from the de?nition of ?marijuana? under Ind. Code 35~48~l ~19, individuals in possession of these substances without meeting the proper conditions are in violation of both state and federal law. Under the Indiana Controlled Substances Act,23 the legislature has determined that substances listed in statutory Schedules I through are considered controlled substances.24 The Indiana Controlled Substances Act further provides that a ?controlled substance? is de?ned to include a drug, substance, or immediate precursor of a drug listed in those schedules and penalty groups.25 The Schedule I classi?cation includes certain hallucinogenic substances.26 For these hallucinogenic substances, Ind. Code 35-48-2-4(d) speci?es that any material, compound, mixture, or preparation containing any quantity of the substance listed under Subsection their salts, isomers, and salts of isomers?are considered a Schedule I controlled substance. This list of substances includes ?Tetrahydrocannabinols? which is a potential ingredient for ?substance containing cannabidiol? under HEA 1148. ?Tetrahydrocannabinols? is de?ned in the list of Schedule I controlled substances under Ind. Code 35?48~2~4 as the following: Ind. Code 35-48-2?4 Schedule I (31) Tetrahydrocannabinols (7370), including equivalents of the substances contained in the plant, or in the resinous extractives of Cannabis, sp.[27] and substances, derivatives, and their isomers with similar chemical structure and pharmacological activity such as: Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions are covered. Other name: THC. 22 See, Newson v. State, 785 1155, 1157 (Ind. Ct. App. 2003). 23 Ind. Code 35~48~1~2 to Ind. Code 35?48-7?14. 2? Ind. Code 35?48?1?9. 25 Ind. Code 35?48?1-9. 26 Ind. Code 35?48?2401). 2? ?Cannabis, Sp.? means any species of the plant genus Cannabis, including Cannabis sativa and Cannabis indica. Page 6 of 14 Based on the statutory de?nition, a ?substance containing cannabidiol? may contain Tetrahydrocannabinol, which results in it being a Schedule I controlled substance that contains equivalents or resinous extractives from the Cannabis plant for purposes of the Indiana Controlled Substances Act. What is more, by specifying that these substances contain material that is derived from non?exempt parts of the Cannabis plant?namely cannabidiol?the legislature classi?ed these substances within the realm of offenses related to marijuana. Regardless of the presence of any THC, cannabidiol is prohibited by the Indiana Controlled Substances Act since it is included in the de?nition of marijuana. Although neither the de?nition of ?cannabidiol? nor ?substance containing cannabidiol? directly reference marijuana or the Cannabis plant, the new statutory provisions contemplate cannabidiol as it relates to marijuana given that cannabidiol is derived from non~exenipt parts of the plant genus Cannabis.28 For purposes of the Indiana Controlled Substances Act, the term ?marijuana? is de?ned in Ind. Code 35-48-1-19 as follows (emphasis supplied): Sec. 19. ?Marijuana? means any part of the plant genus Cannabis whether growing or not; the seeds thereof; the resin extracted ??om any part of the plant, including hashish and hash oil; any compound, manufacture, salt derivative, mixture, or preparation of the plant, its seeds or resin. The term. does not include: (1) the mature stalks of the plant; (2) ?ber produced from the stalks; (3) oil or cake made from the seeds of the plant; (4) any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom); (5) the sterilized seed of the plant which is incapable of germination; or (6) industrial hemp (as de?ned by IC Because ?cannabidiol? is derived from non-exempt parts of the plant genus Cannabis, it squarely falls under the statutory de?nition of marijuana.30 Moreover, given that a ?substance containing cannabidiol? is de?ned to contain Tetrahydrocannabinols which contain equivalents or resinous extractives of the Cannabis plant, any substance containing cannabidiol would also fall under the statutory definition of marijuana. Yet, the statute also provides exceptions to the de?nition of ?marijuana? under Subsections through To determine whether any of these exceptions apply to a substance containing cannabidiol, it is 28 Ind. Code 16?42?2866; see also H. Melleken H. Hussrnan, Cannabinoid in seed extracts of Cannabis sativa cultivars, J. INT. HEMP ASSOC. 73?79 (1997); S. Ross et al., GC-MS Analysis of?ie Total A 9- THC Content of Both Drug? and iber-T ype Cannabis Seeds, 24 J. ANAL. TOXIC. 715?71 7 (2000). 29 (Emphasis added). 30 H. Melleken H. Hussman, Cannabinoid in seed extracts of Cannabis sativa cultivars, 5. INT. HEMP ASSOC. 73~79 (1997); S. Ross et al., Analysis ofthe Totai A9-THC Content ofBoth Drug? and Fiber-Type Cannabis Seeds, 24 J. ANAL. TOXIC. 715?717 (2000). Page 7 of 14 necessary to consider which part of the Cannabis plant these substances are derived from most commonly. The chemical compounds of cannabidiol?de?ned as in Ind. Code Tetrahydrocannabinol are most commonly derived from the resinous ?oral bracts and leaves of the Cannabis plant.? In fact, it is well established that cannabidiol cannot be meaningfully produced from the plants? seeds or stalks.3'2 While small amounts of the cannabinoid may be found on the stalk of certain varieties of the Cannabis plant, the greatest concentrations of cannabidiol are found in the ?oral bracts and leaves of the plant.33 This understanding is consistent with the analysis that ?cannabinoids are not found in the parts of the Cannabis plant that are excluded from the [federal] CSA de?nition of marijuana, except for trace amounts (typically, only parts per million)? and ?based on the scienti?c literature, it is not practical to produce extracts that contain more than trace amounts of cannabinoids using only the parts of the Cannabis plant that are excluded from the [federal] CSA de?nition of As such, the only possible exception to exclude cannabidiol from the de?nition of ?marijuana? would be based on whether either substance could be considered ?industrial hemp? as de?ned by Ind. Code 15?15~13?6. a. Indiana?s industrial hemp exception does not apply to ?cannabr'diol? or ?substance containing cannabidiol. In 2014, the Honorable Governor Michael R. Pence signed SEA 35735 into law, authorizing the Indiana State Seed Commissioner (?Commissioner?) to license the cultivation and production of industrial hemp under Indiana?s Industrial Hemp Law Additionally, the legislation required the Commissioner to apply for any necessary permissions, waivers, or other forms of legal status by the DEA before January 1, 2015, in order to implement the new statutory provisions regarding industrial hemp.? Until permission is granted from federal authorities, neither individuals nor companies are permitted to grow industrial hemp or possess its seeds in Indiana.38 As discussed in further detail in?a, federal authorities have only granted limited authorization of industrial hemp as of the date of this opinion. In fact, Section 7606 of the 2014 federal Farm provided federal legal framework for Indiana?s 31 Galovski, Austin. Marijuana ?3 Impact on CaZg'fornia High Intensity Drug Tra?icking Report 2016. United States: Smart Approaches to Marijuana (SAM, 2016), p. 53.; see also Karl W. Hillig Paul G. Mahlberg, A chemotaxonomic of cannabinoid variation in Cannabis (Cannabaceae), American Journal of Botany, June 2004, vol. 91 no. 6, 966-975. 32 Id. 33 Id. 34 DEA Diversion Control Division, Clara?ication of the New Drug Code 7350f0r Marijuana Extract, available at extract 73 50.html (last visited November 20, 2017). 35 Senate Enrolled Act 357 36 (SEA 357). 371nd. Code 15?15?13?15. 38 Id. Page 8 of 14 Industrial Hemp Law39~wclearly limits the cultivation of hemp for research purposes to institutions of higher education and state departments of agriculture.40 For purposes of licensing the cultivation and production of industrial hemp, the term ?industrial hemp? is de?ned in Ind. Code 15~15~13~6 as follows: Sec. 6. As used in this chapter, ?industrial hemp? means: (1) all nonseed parts and varieties of the Cannabis sativa plant, whether growing or not, that contain a crop wide average tetrahydrocannabinol (THC) concentration that does not exceed the lesser of: (A) three-tenths of one percent on a dry weight basis; or (B) the percent based on a dry weight basis determined by the federal Controlled Substances Act (21 U.S.C. 801 et seq); or (2) any Cannabis sativa seed that is: (A) part of a growing crop; (B) retained by a grower for future planting; or (C) for processing into, or use as, agricultural hemp seed. The term does not include industrial hemp commodities or products. [41] Based on Subsection (1) of this de?nition, it is possible that a substance containing cannabidiol could be considered a substance that contains ?industrial hemp.? Both de?nitions include either a direct or indirect reference to substances derived from a Cannabis plant, and both de?nitions limit the amount of Tetrahydrocannabinol in the substance to not more than three- tenths percent by weight. However, the last line of Ind. Code 15?15?136 speci?es that ?industrial hemp? is not de?ned to include the commodities or products of industrial hemp. The term ?industrial hemp commodities? as used in Ind. Code 15?15?1 3?6 is not de?ned, and the more generic term ?commodity?42 is also not de?ned anywhere under Title 15. Black?s Law Dictionary de?nes ?commodity? broadly as article of trade or commerce.?43 It is plausible that one could argue that the limitation on the amount of Tetrahydrocannabinol in both Ind. Code and Ind. Code means that, by de?nition, a ?substance containing cannabidiol? could be derived from ?industrial 39 Ind. Code 15?15?13?1 (?Nothing in this chapter authorizes any person to violate any federal law or regulation?) ?0 7606 ofthe 2014 Farm Act, Agricultural Act of2014, Pub. L. No. 113-79, 128 Stat. 912-13, (codi?ed, as amended, at 7 U.S.C.A. 5940 (2017)). ?1 (Emphasis added). ?2 However, Ind. Code 15?16?5-1 does de?ne the term ?agricultural commodity? to mean ?any plant or part of a plant and animals or animal products produced primarily for sale, consumption, propagation, or other use by humans or animals.? While other provisionsmsuch as under Ind. Code 15-15?13?7? further specify that industrial hemp is an agricultural product, the exception under the Indiana Controlled Substances Act for the de?nition of ?marijuana? is speci?c only to the provisions under Ind. Code 15- 15-13-6. 43 LAW DICTIONARY (10th ed. 2014). Page 9 of 14 hemp,? and therefore it could be considered an industrial hemp product or commodity. Yet, that conclusion provides little utility here. Even if a substance containing cannabidiol would be considered derived from industrial hemp, it is not covered under Indiana?s Industrial Hemp Law due to the express exclusion of ?industrial hemp commodities or products. ?44 Accordingly, it is not exempt from the de?nition of ?marijuana? under the Indiana Controlled Substances Act. The language of the HEA 1148 is very speci?c and limited. Any argument of a contrary legislative intent is without merit. First, the legislature created a very speci?c limited exception to cannabidiol, in which it is an af?rmative defense to the possession of cannabidiol. The fact that the legislature made it an af?rmative defense and not an exception under the de?nition of marijuana evinces the legislature?s choice to de?ne a substance containing cannabidiol as ?marijuana? and make it a defense if the individual possessing the substance satis?ed certain conditions. If the legislature had intended to legalize cannabidiol under the then the recent law would not have been necessary. Furthermore, one cannot reasonably argue that cannabidiol was intended to be available for all children regardless of any medical condition and completely without regulation. The plain and ordinary meaning of the language simply does not support that expansive understanding. Recognizing that it is unnecessary to the conclusions above, the current status of federal law and regulations over marijuana and industrial hemp further informs this analysis of HEA 1148. HEA 1148 does not a?ect enforcement of the federal Controlled Substances Act (CSA), 21 U.S.C. 801, et seq. The provisions under Ind. Code 16?42?286, et seq. do not diminish the federal authority to enforce federal laws relating to marijuana regardless of state law. The DEA is the federal agency in charge of enforcing the federal Controlled Substances Act (CSA), 21 U.S.C. 801, et sea.45 The CSA creates ?ve schedules of substances. Numerous natural and substances are placed on one of these ?ve schedules based upon assessments of the substances? medical uses, abuse potential, safety issues or tendency toward causing dependence on the part of the user. Generally speaking, a substance and a product that can be derived from that substance are listed in the same schedule.46 a. The de?nition of ?marijuana? under the federal CSA includes ?cannabidiol? and ?substance containing cannabidiol? as de?ned by Indiana. The CSA de?nition of ?marijuana? speci?cally includes ?all parts of the plant Cannabis sativa L, whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin?? As one advances through the process of de?nition, a series of exclusions and exemptions come into play under the statutes; these will be discussed in greater detail, in??a. 4? Ind. Code 15-15-86 45 The rules and regulations enforcing the CSA are located under 21 CPR. Part 1308. 46 21 U.S.C. 812(c), Schedules 47 21 U.S.C. 802(a)(16). Page 10 of 14 Plants grown to produce marijuana as a drug and plants grown to produce hemp products both derive from plants belonging to the genus Cannabis.48 The government?s long~held View is that Cannabis is a single, polytrophic genus that can manifest differing characteristics. Varieties can therefore be developed through hybridization to exhibit desired attributes, such as low? Tetrahydrocannabinol forms or high~cannabidiol forms. This is why the United States Congress, federal enforcement authorities, and courts traditionally have held fast to the botanical characterization of all parts of the Cannabis plant identified in the definition under the CSA as marijuana.49 In December 2016, the DEA promulgated a final rule establishing a new drug code 7350 for ?Marihuana extract? under Schedule I of the CSA.50 Since cannabidiol is extracted from the prohibited parts of the Cannabis plant~specifically, the buds, leaves, and resins extracted from non-sterile seedsmcannabidiol is a prohibited marijuana extract.51 The described approach delivers us squarely to the conclusion that cannabidiol is illegal under federal law, and under the application of state law.52 For purposes of the DEA classi?cation system of illicit drugs, botany is the distinction. The issue is not whether cannabidiol, standing alone, creates a effect in the user. The issue for purposes of the CSA classi?cation comes down to whether the substance is derived from the genus Cannabis and parts of the plant that are within the CSA definition of ?marijuana.? b. he federal exemption for ?industrial hemp? is not applicable for ?cannabidiol? and ?substance containing cannabidiol? as de?ned by Indiana. On February 4, 2014, the US. Congress approved the Agricultural Act of 20 1 4,53 otherwise known as the ?2014 Farm Bill.? 48 The scienti?cally accepted means of classifying all life forms is tied to the notion of ?binomial nomenclature.? Under this convention, all life is classi?ed by the organism?s membership in narrowing categories known as Kingdom, Phylum, Class, Order, Family, Genus, and Species. Cannabis is the genus common to all marijuana and hemp plants, though the species may vary between them. 49 See, US. v. Sanapaw, 366 F.3d 492, 495 (7th Cir. 2004) (citing to numerous other courts and stating that is absurd to believe that Congress intended to ban the euphoric effect of one species of marijuana but not the exact same euphoric effect of other species of marijuana . . 5? Establishment of a New Drug Codefor Marihuana (sic) Extract, 80 Fed. Reg. 90,194-196 (Dec. 14, 2016), codi?ed at 21 C.F.R. 5? DEA Diversion Control Division, Clarification of the New Drug Code 7350 for Marijuana Extract, available at (last visited November 20, 2017). 52 The United States Food and Drug Administration (FDA) which is authorized to regulate and support scienti?c research on the potential therapeutic uses of marijuana compounds, 21 U.S.C. 301, et sea, as amended, also determined that ?products containing [cannabidiol] are outside the de?nition of a dietary supplement.? FDA Inspections, Compliance, Enforcement, and Criminal Investigations, Warning Letter, Sana Te 2/4/16, EnforcementActions/ Warn in gLetters/ZO 6/uc1n484987.htm (last visited September 11, 2017). No cannabidiol-related product has received FDA approval. Id. 53 Agricultural Act of2014, Pub. L. No. 113?79, 128 Stat. 912-13, (codi?ed, as amended, at 7 U.S.C.A. 5940 (2017)). Page 11 of 14 The 2014 Farm Bill de?nes ?industrial hemp? as: ?[T]he piant Cannabis sativa L. and any part of such plant, whether growing or not, with a THC concentration of not more than 0.3 percent on a dry weight basis.?54 Section 7606 amounts to an exception to the CSA for the limited growth, cultivation and marketing research experimentation for industrial hemp by an institution of higher education or a state department of agriculture, if such activities are conducted within federal legal boundaries. Furthermore, Section 7606 authorized state departments of agriculture to promulgate regulations necessary to carry out these pilot programs; however, it did not provide speci?c delegation to the USDA or any other agency to implement the program. On August 12, 2016, the USDA, in consultation with the DEA and the FDA published a Statement of Principles on Industria! Hemp (?Statement of Principles?) in the Federal Register to inform the public about how federal law applies to activities associated with industrial hemp grown and cultivated in accordance with Section 7606. The Statement of Principles reiterate that Section 7606 did not remove industrial hemp from the controlled substances list: .. Federal law continues to restrict hemp-related activities, to the extent that those activities have not been legalized under Section 7606.?55 Additionally, the Statement of Principles outlines nine principles to inform educational institutions and state governments that want to participate in industrial hemp agricultural pilot programs in accordance with federal law. One of these principles specifies that for purposes of marketing research (including distribution of marketing materials) under Section 7606, industrial hemp products may only be sold in a state with an agricultural pilot program; however, these products may not be sold or exchanged in states where sales are otherwise prohibiteds? Notably, the IHL expressly excludes ?industrial hemp commodities or products? from its de?nition of ?industrial hemp?? Moreover, marketing research may not be for the purpose of general commercial activity, and industrial hemp plants and seeds may not be transported across state lines. In a statement to the public,58 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 de?ned 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 the Cannabis plant. This is a direct example of ajoint af?rmation of federal policy, promulgated by three separate federal agencies, af?rming that no industrial hemp pilot program, state or federal, is intended to encompass products for immediate human consumption as food, a food supplement, or a drug. 5? 7606 ofthe 2014 Farm Act, Agricultural Act of2014, Pub. L. No. 113?79, 128 Stat. 912?13, (codi?ed as ariiended, at '7 U.S.C.A. 5940 (2017)). 55 81 Fed. Reg. 53,395 (Aug. 12, 2016). 561d. 57 Ind. Code 15-15-13?6 58 DEA Statement on CBD, Hemp and ?Farm. Bill (Aug. 2015) (on ?le with the authors). Page 12 of 14 For all of the reasons stated above, possession of cannabidiol remains prohibited under federal law, regardless of the circumstances, and is therefore potentially subject to seizure by any law enforcement agency. IV. Seizures are permissible when a substance containing cannabidiol is in plain view. In View of the foregoing analysis, which concludes that a substance containing cannabidiol is legally categorized under state and federal law as marijuana, questions arise as to the what appropriate actions may be taken by responsible law enforcement officials. The Fourth Amendment of the Constitution of the United States allows the warrantless seizure of contraband when three factors are met: 1) the officer must be rightfully occupying the location; 2) the item must be in plain View; and, 3) the incriminating nature of the evidence must be immediately apparent.59 Under this standard, the rationale is that if contraband is left in open view and is observed by a police of?cer from a lawful vantage point, there has been no search within the meaning of the Fourth Amendment.60 Article 1, Section 11 of the Indiana Constitution requires a different analysis that focuses on the reasonableness of police conduct, which is analyzed by balancing: l) the degree of concern, suspicion, or knowledge that a violation has occurred; 2) the degree of intrusion the method of the search or seizure imposes on the citizens? ordinary activities; and (3) the extent of law enforcement needs.61 Illegal cannabidiol products, openly for sale at a number of traditional retail stores and by other commercial channels throughout the state, can be characterized as illegal contraband, subject to warrantless seizure under the Fourth Amendment of the Constitution of the United States and Article 1, Section 11 of the Indiana Constitution. Especially since no one is authorized to distribute or sell cannabidiol in Indiana under either federal or state law. An entire stock or inventory of products clearly labeled as containing cannabidiol, that are lawfully in the plain view of a police officer, are subject to warrantless seizure. Testing of the products is not a precondition to the seizure. If subsequent testing should find that products were mislabeled as to the ingredients contained therein, or that they actually contain no cannabidiol whatsoever, Ind. Code 3548?4?45, 35-48-446, and 35484?5 provide for the prosecution of certain offenses related to substances that are represented to be a controlled substance. 59 See, Wilkinson v. State, 70 392, 402 (Ind. Ct. App. 2017) (citing Jones v. State, 783 1132, 1137 (Ind. 2003)). 60 See, Minnesota v. Dickerson, 508 US. 366, 375 (1993). 61 See, Wilkinson, 70 at 405. Page 13 of 14 CONCLUSION We understand that cannabidiol is a substance about which we know very little, and about which many hold out a good deal of hope that it may be that elusive cure for any number and kind of disease. One hopes, for the sake of those who are suffering any of these maladies, that it can be so. But hoping and wishing are not the proper role of government. Our job is to place our fellow citizens fairly on notice about what the laws passed by their representatives really mean. As the analysis represented by this opinion has shown, the legal conclusion is that cannabidiol is illegal to buy, sell, possess or use in the State of Indiana. Yes, a narrowly drawn exception exists in the form of an affirmative defense for properly registered caregivers and children sufferingifrom treatment-resistant epilepsy. This affirmative defense would only apply to prosecutions under state law. However, they may still be subject to federal prosecution. Therefore, anyone possessing a substance containing cannabidiol, or anything packaged as such, in plain View of a law enforcement of?cer is subject to having that property seized. Only upon a Showing that said individual meets the limited conditions under Indiana law, could that individual not be prosecuted under state law. Furthermore, no one in Indiana is authorized to sell cannabidiol under either federal or state law, and therefore, any retail establishment selling anything that contains cannabidiol is in violation of the law. SUBMITTED, and Scott C. Newman Chief Counsel, Advisory Division Page 14 of 14