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Food and Drug Administration 5630 Fishers Lane, Rm April 23, 2018 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Submitted electronically through www.regulations.gov Re: Docket No. FDA-2018-N-1072 International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9- Tetrahydrocannabinol (THC); Stereoisomers of THC; Cannabidiol; Request for Comments. We are The New York Cannabis Bar Association, a group of New York attorneys seeking to implement a comprehensive adult-use cannabis regulatory program and expand access to medical cannabis in New York. Since our inception we have routinely convened interdisciplinary meetings consisting of our members, doctors, drug policy advocates, and patients who are dedicated to help shape a well-rounded, legal cannabis industry in New York. Our collective expertise spans decades of work in the legal, medical and drug policy fields in New York, California, Oregon, Maryland, New Jersey, Illinois, Michigan, Connecticut, Colorado, Pennsylvania, England, Canada, Jamaica, Argentina, and the Netherlands. Many of us have participated as practitioner, counselor, and/or patient in medical cannabis programs around the world. We offer the following comments in response to The World Health Organization’s (WHO) consideration in deciding whether to recommend a change in international control/de-control of the cannabis plant and cannabis resin; extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), and stereoisomers of THC. Our organization supports de-control of the cannabis plant and cannabis resin; extracts and tinctures of cannabis; THC, CBD, and stereoisomers of THC. The regulatory approach utilized by the United States, and globally, of Cannabis and Cannabis Derivatives has proven to be overly restrictive to medical professionals seeking to provide the best treatment to patients, counter intuitive to documented trends and analytical reports on drug abuse and abuse potential, and chilling to medical research that would benefit the population as a whole. On behalf of the New York Cannabis Bar Association Rebecca Greenberg, Esq. Cristina Buccola, Esq. COMMENTS ON THE MEDICAL USEFULNESS OF CANNABIS AND CANNABIS DERIVATIVES It is irrefutable that overwhelming research evidence supports the medical effectiveness of the cannabis plant1 and cannabis resin,3 extracts4 and tinctures of cannabis,5 THC,6 CBD,7 and stereoisomers of THC ("Cannabis and Cannabis Derivatives”). The WHO has already acknowledged the therapeutic effects of cannabinoids (including THC) for asthma, glaucoma, depression, nausea and vomiting.8 The United States Federal Government long ago acknowledged that Cannabis and Cannabis Derivatives have medical benefit.9 Further, 30 States in the United and at least 31 countries currently recognize Cannabis and Cannabis Derivatives as a legitimate medical treatment modality for medical conditions that include, but are not limited to, Amyotrophic Lateral Sclerosis (ALS),10 Alzheimer’s Disease,11 Chronic Pain and Severe Pain,12 1 See Mark S. Wallace et al., Efficacy of Inhaled Cannabis on Painful Diabetic Neuropathy, 16 J Pain. 616, 616–627 (2015).; See Barth Wilsey et al., Low-dose vaporized cannabis significantly improves neuropathic pain, 14 J Pain. 136, 136–118 (2013); See Mark Ware et al., Smoked cannabis for chronic neuropathic pain: a randomized controlled trial, 182 Canadian Med. Ass’n. J. E694, E694–701 (Oct. 2010); See Ronald Ellis et al., Smoked medicinal cannabis for neuropathic pain in HIV: a randomized crossover clinical trial, 34 Neuropsychopharmacology 672–80 (2009); See also Barth Wilsey et al., A Randomized, Placebo-Controlled, Crossover Trial of Cannabis Cigarettes in Neuropathic Pain. 9 J. Pain 506, 506–21 (2008); Jody Corey-Bloom et al., Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebo-controlled trial, 10 Can. Med. Ass’n. J. 1143, 1143–1150 (2012); Adi Lahat et al., Impact of cannabis treatment on the quality of life, weight and clinical disease activity in inflammatory bowel disease patients: a pilot prospective study, 85 Digestion 1, 1–8 (2012). 3 See Torsten Passie et al., Mitigation of post-traumatic stress symptoms by Cannabis RESIN: A review of the clinical and neurobiological evidence, 4 Drug Test Anal. 7-8, 649-659 (2012). 4 See M. Lynch et al., A double-blind, placebo-controlled, crossover pilot trial with extension using an oral mucosal cannabinoid extract for treatment of chemotherapy-induced neuropathic pain, 47 J. Pain Symptom Mgmt. 166 (2014). 5 EB Russo et al., Cannabis improves night vision: A pilot study of dark adaptometry and scotopic sensitivity in kif smokers of the Rif Mountains of Northern Morocco, 93 J Ethnopharmacol 1 (2004) 6 See M. Serpell et al., A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment, 18 EUR. J. Pain 999, 999–1012 (2014); See Miriam Fishbein et al., Long- term behavioral and biochemical effects of an ultra-low dose of D9-tetrahydrocannabinol (THC): neuroprotection and ERK signaling, 221 Experimental Brain Res. 437, 437–48 (2012); Abir T. El-Alfy et al., Antidepressant-like effect of Δ9-tetrahydrocannabinol and other cannabinoids isolated from Cannabis sativa L, 95 Pharmacology Biochemistry and Behavior 434, 434–42 (2010). 7 Ana Juknat et al., Anti-inflammatory effects of the cannabidiol derivative dimethylheptyl-cannabidiol–studies in BV-2 microglia and encephalitogenic T cells, 27 J. Basic and Clinical Physiology and Pharmacology 289, 289–296 (2016); Ewa Kozela et al., Cannabidiol, a non-psychoactive cannabinoid, leads to EHR2-dependent energy in activated encephalitogenic T cells, 12 J. Neuroinflammation 52 (2015); Ewa Kozela et al., HU-446 and HU-465, Derivatives of the Non-psychoactive Cannabinoid Cannabidiol, Decrease the Activation of Encephalitogenic T Cells, 87 Chemical Biology & Drug Design 143, 143–153 (2016). 8 http://www.who.int/substance_abuse/facts/cannabis/en/ 9 National Commission on Marihuana and Drug Abuse. 1972. Marihuana: A Signal of Misunderstanding. Washington DC: U.S. Government Printing Office. http://www.druglibrary.org/schaffer/library/studies/nc/ncmenu.htm. 10 “legally treatable” condition in Arizona, Connecticut, Delaware, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, New York, and Pennsylvania 11 “legally treatable” condition in Arizona, Delaware, Michigan, New Hampshire, Ohio, and Rhode Island Chronic Traumatic Encephalopathy,13 Complex Regional Pain Syndrome,14 Epilepsy,15 Muscle Spasticity Disorders,16 Neuropathy and Peripheral Neuropathy,17 Nerve Damage involving the Spinal Cord and Traumatic Brain Injury,18 Parkinson’s Disease,19 Post-Laminectomy Syndrome with Chronic Radiculopathy,20 Seizure Disorders,21 Spasmodic Torticollis,22 Tourette’s Syndrome,23 HIV or AIDS,24 Multiple Sclerosis,25 Crohn’s Disease,26 Glaucoma,27 Post-Traumatic Stress Disorder,28 Cachexia or Wasting Syndrome,29 Anorexia,30 and Nausea.31 Cannabis and Cannabis Derivatives have also been shown in medical research to inhibit tumor growth and reduce tumor mass size in breast cancer studies,32 glioma brain tumor studies,33 pancreatic cancer studies,34 leukemia studies.35 12 legal treatment for Chronic Pain and Severe Pain in Alaska, Arizona, California, Colorado, Delaware, Maryland, Massachusetts, Michigan, Montana, Nevada, New Hampshire, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington 13 “legally treatable” condition in Ohio 14 “legally treatable” condition in Connecticut 15 “legally treatable” condition in Alaska, Arizona, California, Colorado, Connecticut, Maine, Michigan, Montana, New Hampshire, New Jersey*, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island 16 “legally treatable” condition in Alaska, Arizona, California, Colorado, District of Columbia, Delaware, Maryland, Michigan, Minnesota, Montana, Nevada, New Hampshire, New Jersey*, New York, New York, Oregon, Pennsylvania, Rhode Island, Washington 17 “legally treatable” condition in New Mexico, New York, Oregon, Pennsylvania, Rhode Island 18 “legally treatable” condition in Connecticut, New Hampshire, New Mexico, New York, Ohio, and Pennsylvania 19 “legally treatable” condition in Connecticut, District of Columbia, Massachusetts, New Hampshire, New Mexico, New York, Ohio, Pennsylvania 20 “legally treatable” condition in Connecticut 21 “legally treatable” condition in Alaska, Arizona, California, Colorado, Delaware, Maine, Michigan, Minnesota, Nevada, New Jersey*, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Washington 22 “legally treatable” condition in New Mexico 23 “legally treatable” condition in Minnesota, Ohio 24 “legally treatable” condition in Alaska, Arizona, Colorado, Connecticut, District of Columbia, Delaware, Maine, Massachusetts, Michigan, Minnesota, Montana, Nevada, New Hampshire, New Jersey*, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Vermont, Washington 25 “legally treatable” condition in Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Maine, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Vermont, Washington 26 “legally treatable” condition in Arizona, Connecticut, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New Mexico, Ohio, Pennsylvania, Rhode Island,
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