A Public Health Framework for Legalized Retail Marijuana: Avoiding a New Tobacco Industry

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A Public Health Framework for Legalized Retail Marijuana: Avoiding a New Tobacco Industry Stanton A.Glantz, PhD Professor of Medicine Director, Center for Tobacco Control Research & Education 9/20/2017

The Irony Tobacco is legal, socially unacceptable, and use is falling Marijuana is illegal, socially sanctioned, and use is increasing So, we want to treat marijuana like tobacco 11/13/2017

Cannabis as Medicine Evidence Conclusive/Substantial Moderate Limited Condition Chronic pain Chemotherapy-induced nausea and vomiting Multiple sclerosis spasticity (patient-reported) Sleep disturbance (various etiologies) HIV/AIDS-associated weight loss Multiple sclerosis spasticity (clinician-measured) Tourette syndrome Anxiety symptoms Posttraumatic stress disorder Traumatic brain injury or intracranial hemorrhage outcomes Source: National Academies of Sciences, Engineering, and Medicine (2017). The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC, The National Academies Press. 4 Regulating Medical Cannabis Manufacturing 9/20/2017

6 Presentation Title and/or Sub Brand Name Here 11/13/2017

Cannabis-Tobacco Policy Overlap Just a few examples: Addiction Adolescent use and initiation Advertising Cardiovascular & respiratory risks Cancer Corporate influence and dominance Co-use and dual use Environmental impact Flavors Packaging/labeling Smokefree environments Social norms key Vaping And more 7 Regulating Medical Cannabis Manufacturing 9/20/2017

Marijuana as a rival product 9 11/13/2017

Cannabis in California Decriminalization civil offense (1975) Reduced to infraction in (2010) Medical legalization (1996 voter initiative) Supplemented by legislation (2003 and 2015) Patchwork of local rules Adult use legalization (2016 voter initiative) MAUCRSA (2017) 10 Regulating Medical Cannabis Manufacturing 9/20/2017

Cannabis in California: MAUCRSA Three agencies regulate medical and adult use Bureau of Cannabis Control Lead agency Retailers; distributors; testing labs; microbusinesses Department of Public Health Manufactured cannabis products Packaging and labeling Department of Food and Agriculture Cultivation Track and trace Significant local control 11 Regulating Medical Cannabis Manufacturing 9/20/2017

12 Cannabis Products

Also All images: Leafly. Products. https://www.leafly.com/products. Accessed Sept. 1, 2017. 13 Regulating Medical Cannabis Manufacturing 9/20/2017

Manufactured Cannabis Products Definition Processed or transformed into more concentrated form Commonly using butane, CO 2, or alcohol Consumed directly (e.g., dabs, extracts, tinctures) Combined with other ingredients (e.g., edibles, topicals) Potency Can be very high THC (over 80%) in concentrates Smoked cannabis current maximum ~30% THC (and a lot lost), more often 10-20% Can be very low THC, high CBD Some not psychoactive at all (most topicals) Method of consumption effect, duration, onset (e.g., edibles) Regulating 14 Medical Cannabis Manufacturing 9/20/2017

Public health framework Legal but discouraged Industry as disease vector Pubic health engagement with policymaking process Marijuana prevention and control program for general population Hard-hitting mass media education campaigns Comprehensive smokefree and other public usage laws Tax revenue for prevention and control program and research Strict marketing and advertising restrictions Plain packaging and state of art graphic warning labels (not current US) 15 11/13/2017

Warning labels 16 11/13/2017

Marijuana Washington Colorado 17 Presentation Title and/or Sub Brand Name Here 11/13/2017

Nevada and California 18 11/13/2017

Protecting the Policy Process The involvement of organizations or individuals with commercial or vested interests in the tobacco industry in public health policies with respect to tobacco control is most likely to have a negative effect [Governments] should not allow any person employed by the tobacco industry or any entity working to further its interests to be a member of any government body, committee or advisory group that sets or implements tobacco control or public health policy.

Advisory Committee Membership

Advisory Committee Membership

State Marijuana Prevention

Tobacco Industry Talk. They ll Listen

Tobacco Control

California: Where we are today Draft rules for medical market issued in April 2017 Withdrawn because of MAUCRSA Give idea of things to come Prop 64 requires agencies to begin licensing by January 2018 Updated rules will be issued on an emergency basis Will take effect immediately, followed by public comment & revision Not usual process of public comment and revision first Problems with draft rules Poor labeling standards High potency limits for manufactured cannabis products 8 ounce daily sale limit for medical cannabis much higher than anywhere else, typically 1 ounce a day or less Allows law enforcement agents to be in cannabis business 25 11/13/2017

Undermines California Smokefree Laws and Norms MAUCRSA allows Smoking, vaping, ingesting in cannabis retailer or microbusiness if age restricted, cannabis not visible from public place, no sale or consumption of alcohol or tobacco on premises. Beer garden style temporary event cannabis consumption at county fairs or agricultural events if consumers admitted are 21+ and the local jurisdiction allows 26 11/13/2017

Labeling: Text Only Static Warnings SCHEDULE I CONTROLLED SUBSTANCE KEEP OUT OF REACH OF CHILDREN AND ANIMALS FOR MEDICAL USE ONLY IF PREGNANT OR BREASTFEEDING, CONSULT A PHYSICIAN PRIOR TO USE THE INTOXICATING EFFECTS OF THIS PRODUCT MAY BE DELAYED BY UP TO TWO HOURS THIS PRODUCT MAY IMPAIR THE ABILITY TO DRIVE OR OPERATE MACHINERY, PLEASE USE EXTREME CAUTION Regulating 27 Medical Cannabis Manufacturing 9/20/2017

Labeling CA proposed regulation ( 40412): universal cannabis product symbol Minimum.5 x.5 size Regardless of package size Printed legibly and conspicuously Vague industry manipulation 28 Regulating Medical Cannabis Manufacturing 9/20/2017

29 Regulating Medical Cannabis Manufacturing 9/20/2017

Labeling Better: Adopt a highly visible and salient cannabis product symbol Colors Black = most visually prominent color Yellow = most effective for gaining and keeping consumer attention, less attractive, signals warning Black + Yellow = danger (e.g., road warnings) Size No direct tobacco control analogue 20% primary panel based on graphic warnings Regulating 30 Medical Cannabis Manufacturing 9/20/2017

Packaging: Abusive Industry Tactics CA Proposed Regulation ( 40410(c)(2)-(c)): prohibits packaging with [c]artoons; [a]ny likeness to images, characters, or phrases that are popularly used to advertise to children; or [a]ny imitation of candy packaging or labeling Should: Eliminate all packaging that appeals to children or imitates any noncannabis product Sources: Chong, O. Cannabis Companies Need to Stop Stealing Intellectual Property. New Cannabis Ventures. Jan. 3, 2017. https://www.newcannabisventures.com/cannabis-companies-need-to-stop-stealing-intellectual-property/. http:/analytical360.com/m/dopecup-2015/383415/, https://www.cannabisreports.com/edible-reports/baked-goods/weetos-crunchy 31 Regulating Medical Cannabis Manufacturing 9/20/2017

Plain packaging for all cannabis products Common for restricted-access medical products (e.g., prescription drugs) Effective for tobacco products Generic labeling and packaging already an option in Oregon Avoid preapproval requirement and fee Source: https://openclipart.org/det ail/190009/prescriptionbottle-and-pills Source: http://www.tobaccolabels.ca/plain-packaging/ Source: http://www.oregon.gov/olcc/marijuana/documen ts/packaging_labeling/checklistandgeneric.pdf 32 Regulating Medical Cannabis Manufacturing 9/20/2017

How Uruguay is doing it Government monopoly on sales Only 2 (low-thc) varieties of product available, and only dried flower Private companies providing the cannabis not permitted to brand packaging Source: http://www.telenoche.com.uy/politica/uruguay-se-convirtio-en-el-laboratorio-del-mundo.html 33 Regulating Medical Cannabis Manufacturing 9/20/2017

Products: Prohibit Harmful Formulations CA proposed regulation ( 40300(b)): prohibits use of additives in cannabis products that would increase potency, toxicity or addictive potential Include but are not limited to nicotine and caffeine Ambiguity: all forms? (e.g., powdered vs. coffee vs. chocolate) BETTER: Prohibit ALL additives that promote addictiveness or initiation, including all nicotine, caffeine, menthol, and characterizing flavors http://www.businessinsider.com/buying-pure-caffeine-powder-off-the-internet-2015-9 34 Regulating Medical Cannabis Manufacturing 9/20/2017

Why prohibit harmful formulations Makes it hard to design more appealing, dangerous products to increase consumption Prohibit menthol as an additive Local anesthetic effect Likely same for inhaled cannabis Conditioned reinforcer for nicotine due to sensory effects Similar effect for cannabis likely (but untested) Menthol cigarette smokers more likely to use cannabis Prohibit all characterizing flavors Known youth appeal for tobacco products, junk food Likely same for cannabis 35 Regulating Medical Cannabis Manufacturing 9/20/2017

Products: Prohibit Harmful Formulations CA proposed regulation ( 40306): limits all nonedible manufactured medical cannabis products to 1000mg THC per unit Too high Non-cannabis topical products are an existing poisoning concern Most cannabis topicals are non-psychoactive on skin, but ingestion is another matter Medical cannabis topicals may resemble commonly encountered products (e.g., lotions or balms) Some look like food (e.g., honey oil) or trade on appeal of food-like flavors Pineapple Dream Concentrate http://www.dopemagazine.com/review-pineappledream-concentrate/ 36 Regulating Medical Cannabis Manufacturing 9/20/2017

Why California Matters History Epicenter of counterculture movement in 1960s First medical legalization state Production Emerald Triangle Humboldt, Mendocino, Trinity Counties Size and influence Largest medical legalization jurisdiction in U.S Will be largest adult use jurisdiction globally Projected 868,000 medical users (currently 1.5M) Projected 4.4M total users in 2018 37 Regulating Medical Cannabis Manufacturing 9/20/2017

Conclusions Absent strong regulation, marijuana industry will increasingly resemble tobacco industry Marketing, product engineering, PR, and political influence to maximize profits Need strong product regulation Attendant health burden Large graphic warnings, rotating warning language, and plain packaging Protect nonusers, smokefree environments Public education modeled on California Tobacco Control Program Taxation to discourage use Strong conflict of interest laws Business interests dominating the policymaking process, by default Once bad policies are put in place, difficult to change Health groups have been silent 38 Presentation Title and/or Sub Brand Name Here 11/13/2017

Acknowledgement Some of the material in this presentation is work I have done in collaboration with my postdoctoral fellows. Daniel Orenstein, JD MPH Candice Bowling, JD MPP 39 Presentation Title and/or Sub Brand Name Here 11/13/2017