FINAL 12/13/2017. The ACT 230 Medical Cannabis Oversight Working Group: Sub-Committee Report on Products. Members:

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1 The ACT 230 Medical Cannabis Oversight Working Group: Sub-Committee Report on Products Members: Senator Rosalyn H. Baker, Act 230 Working Group Chair, Senate Committee on Commerce, Consumer Protection, and Health Michael Takano, Chair, Pono Life Sciences Maui, LLC, Dispensary Industry Representative (Maui County) Bill Jarvis, Qualifying Patient over the age of 18, Patient advocate Jon-Paul Bingham, College of Tropical Agriculture, University of Hawaii Karen Kahikina, Highway Safety Specialist, Hawaii Department of Transportation John McAuliffe, Highway Safety Specialist, Hawaii Department of Transportation Christopher Garth, Executive Director, Hawaii Dispensary Alliance Racquel Bueno, MD, FACS, Chief Scientific Officer, Pono Life Sciences, LLC Recommendations: 1. Per HRS 329D-10 (Act 230 Section 17): The types of medical marijuana products that may be manufactured and distributed pursuant to this chapter shall be limited to: Capsules; (2 ) Lozenges ; (3) Pills; (4) Oils and oil extracts; (5) Tinctures; (6) Ointments and skin lotions, (7) Transdermal [patches] devices; (8) Pre-filled and sealed containers used to aerosolize and deliver marijuana orally, such as with an inhaler or nebulizer; (9) Cannabinoid suppositories; and Other products as specified by the department Limitation to patch vs. device was unintentional. The technical flaw impedes viable products and innovation.1 2. Per HRS 329D-10 (a) (Act 230 Section 17): The types of medical marijuana products that may be manufactured and distributed pursuant to this chapter shall be limited to: Capsules; (2 ) Lozenges ; (3) Pills; (4) Oils and oil extracts; (5) Tinctures; (6) Ointments and skin lotions, (7) Transdermal patches; (8) Pre-filled and sealed containers used to aerosolize and deliver marijuana orally, such as with an inhaler or nebulizer; (9) Cannabinoid suppositories; and Other products as specified by the department. Like transdermal devices, suppository delivery is an advantageous form of drug administration because it avoids the first-pass metabolic effects of oral ingestion and can ensure stable blood levels of the administered drug over long periods of time, which can reduce side effects.2 Suppository administration is a favorable option for patients who have difficulty with oral administration. Act 230 LOWG Subcommittee Report on Products

2 See Oregon section for Definition: Cannabinoid suppository means a small soluble container designed to melt at body temperature within a body cavity other than the mouth, especially the rectum or vagina, containing a cannabinoid product, concentrate or extract 3. Allow for stationary at home (non-portable? non-handheld) medical-grade volatilization devices that are regulated to prevent the combustion of cannabis (i.e. heat convection or conduction).3 Offering smoke-free delivery options for flower and oils align with Hawaii s smoke free campaign and expand patient choice to administration with fewer undesirable sideeffects.4 Provided below are examples of stationary volatilization devices that do not utilize combustion: Example 1 Example 2 Example 3 4. Consider creating a legislative pathway for Edibles (Medical Cannabis-infused foods Exhibit A). The Act 230 Legislative Oversight Working group is tasked with addressing issues related to the medical maruana dispensary program in the State, including operations, edibles. 5 Currently, cardholders may purchase oil extracts from dispensaries. Obtaining oil extracts allow cardholders to make edibles at home. Creating a pathway for statelicensed dispensaries to produce edibles promotes safe consumption of quality assured products produced under Hawaii Food Safety Code (HAR 11-50). Americans for Safe Access provides an annual patient-focused to analyze State medical cannabis laws. The report grades states on access to product other than dried product: Edibles are important, as this form of administration is ideal or preferred for certain ailments and can offer ease of use for certain patients. States without this explicit right but that allow for availability of these products in practice were eligible for partial points. While tolerance is better than denying access to alternative forms, clear guidance is optimal, and ASA encourages states to protect and regulate the manufacturing, use, and distribution of edible and concentrated medical cannabis products. 6 Two-thirds of the 29 states and the District of Columbia that have legal medical cannabis programs, permit edibles.7 Model legislation includes: Florida s Title XXIX, Chapter 381 provision to allow for edible products, subject to DOH rulemaking. This approach could create a pathway for the future expansion, while establishing certain priorities: not geared for children, THC/CBD and portion control limits, food establishment license and food safety standards. The Department of Agriculture and Consumer Services will Act 230 LOWG Subcommittee Report on Products 2

3 assist the DOH in developing the testing requirements for contaminants that are unsafe for human consumption in edibles. Arizona Revised Statutes Title 36 Chapter 28.1 requires that: Dispensaries apply for an additional Food Establishment License for Potentially Hazardous Food Before preparing, selling, or dispensing cannabis-infused edible food product, to obtain written authorization from the Department to prepare, sell, or dispense marijuana-infused edible food products. If the dispensary prepares the marijuana-infused edible food products, ensure that the cannabis-infused edible food products are prepared according to the applicable requirements. Illinois Compassionate Use of Medical Cannabis Pilot Program Act: Concerns Prohibits cannabis infused products requiring refrigeration or hotholding shall be manufactured for sale or distribution at a dispensary due to the potential for food-borne illness. Requires that all items shall be individually wrapped at the original point of preparation. The packaging of the medical cannabis infused product shall conform to the labeling requirements of the Illinois Food, Drug and Cosmetic Act. Includes pathway for The Department of Public Health to adopt rules for the manufacture of medical cannabis-infused products for sale, storage, sale, distribution or transportation of medical cannabis edible products, to inspect the premises and all utensils, fixtures, furniture, and machinery used for the preparation of these products. 1. The current market for volatilization devices features a variety of handheld, portable products that mimic ecigarette products. Such devices induce risks of (1) Enforcement of public cannabis vs. ecigarette usage (2) Diversion of legal medical cannabis product (3) Increased gateway to cigarette or tobacco use by medical cannabis program patients; (4) Potentially dangerous technology present in ecigarette technology 2. Overconsumption of cannabis is frequently linked to the consumption of cannabisinfused foods, as the effects of the product are delayed when the ingested orally. Further, unlike capsules or pills, users may be prone to consume multiple doses in one sitting, particularly if the cannabis-infused food is a candy, such as gummies or chocolates. Candies and other non-functional foods also pose a greater risk of diversion to unauthorized users and minors. Act 230 LOWG Subcommittee Report on Products 3

4 References 1. For recent developments in transdermal delivery mechanisms including chemical penetration enhancers, physical permeabilization (sonophoresis, iontophoresis and microneedles) and novel nanocarriers. See: 1) Zhang H. et. al. Breaking the skin barrier: achievements and future directions. Curr Pharm Des. 2015;21(20): httpsi/ 2) Prausnitz MR, Langer R. Transdermal drug delivery. Nature biqtechnology. 2008;26(1 1): doi: /nbt Suppositories bypass the first-pass effect and led to sustained elevation of drug plasma levels. Higher, more sustained plasma drug levels should enhance antiemetic efficacy (Mattes RD et. a11993). (Larry A. Walker et. al. 1999) Administration of the THC-HS via suppositories resulted in excellent bioavailability, sustained plasma levels of THC, and improved efficacy as compared to the oral formulations. 3. Volatilization through heat convection or conduction reduce the risk of product combustion, through allowing the device to heat at a lower temperature. 4. A survey of 6883 cannabis users found that volatilization, compared with smoking, causes fewer respiratory symptoms (coughing, wheezing, shortness of breath, mucus production) (Earlywine and Barnwell 2007). Because of the tars and gases produced during the combustion process, cannabis smoke is toxic to airway tissue, and probably carcinogenic (Fung et. al. 1999), whereas volatilization may significantly reduces Toxins (Pyrenes and Polynuclear Aromatic Hydrocarbons) in cannabis smoke (Gieringer. St. Laurent, and Goodrich 2004) 5. Act 230 Medical Cannabis Legislative Oversight Working Group: 6. Americans for Safe Access Medical Marijuana Access in the United States, 2017 Annual Report. maruuana access in the usa. 7. States with legislation that permits edibles include: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Illinois, Maine, Maryland, Massachusetts, Michigan, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Washington. Act 230 LOWG Subcommittee Report on Products 4

5 Exhibit A Amend 329D-10 to include (c) The department shall establish standards with respect to the manufacture of medical cannabis-infused foods for sale, provided that the standards, at a minimum shall require that: (1) A dispensary licensee that produces medical cannabis-infused foods shall hold a permit to operate as a food establishment pursuant to HAR1 1-50, Hawaii Food Code, and must comply with all the requirements for food establishments pursuant to and any rules adopted thereunder; (2) Medical cannabis infused foods may not be attractive to children; be manufactured in the shape of humans, cartoons, or animals; be manufactured in a form that bears any reasonable resemblance to products available for consumption as commercially available candy; or contain any color additives. To discourage consumption of edibles by children, the department shall determine by rule any shapes, forms, and ingredients allowed and prohibited for edibles. (d) Medical cannabis-infused foods means commercially produced food items made with cannabis oil, but no other form of cannabis, that are produced and dispensed by a medical cannabis dispensary. Act 230 LOWG Subcommittee Report on Products 5