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From: International Research Center on Cannabis and Mental Health 1115 Broadway, 11Th Floor New York, NY 10010 (917) 565-9046

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From: International Research Center on Cannabis and Mental Health 1115 Broadway, 11Th Floor New York, NY 10010 (917) 565-9046 From: International Research Center on Cannabis and Mental Health 1115 Broadway, 11th floor New York, NY 10010 (917) 565-9046 To: Division of Dockets Management (HF A-305) Food and Drug Administration 5630 Fishers Lane, Room I030 Rockville, MD 20852 Re: Dietary Supplement Products Containing Cannabis or Cannabis Derived Compounds Docket FDA-2019-N-1482 Dear Madam/Sir, My name is Jahan Marcu, Ph.D, Chief Science Officer at the International Research Center on Cannabis and Mental Health (IRCCMH). My colleague and IRCCMH Co-founder and CEO, Dr. Jan Roberts, LCSW, and I concur with the FDA’s consistent focus on protecting the public health. We believe our respective backgrounds can be helpful to the FDA’s deliberations on Cannabis and Hemp-Derived Compounds. We are accordingly submitting this comment for consideration (in regard to the FDA’s Working Group on Cannabis Containing Products) and would be pleased to be a resource (as deemed appropriate) for the FDA in its deliberations around this important topic. If useful, this could include collaboration on the topic broadly as well as providing data from IRCCMH safety studies; or conducting additional safety studies if needed. In order to provide useful context, the International Research Center on Cannabis and Mental Health is a community-based research institute based in New York City. IRCCMH was founded with a center grant from New York University where Dr. Roberts. IRCCMH leverages a strong industry network, collaborating with universities, researchers, foundations, state institutions, and others to leverage the highest caliber talent in the field. In addition to being a Co-Founder of IRCCMH, I have over 15 years of experience in the cannabis industry, stemming back to when I initially volunteered for Americans for Safe Access and was Director of their Patient Focused Certification program (an organization and program that also emphasized public health and safety). I am also fortunate to have earned a Ph.D. focused on the endocannabinoid system (with research on the structure and function of cannabinoid receptors, molecular pharmacology of the endocannabinoid system, and the role of the ECS in bone). That education was extremely instructive about the potential medical benefits worthy of significant research (and support). My professional roles have included the CSO role at Americans for Safe Access, as well as chairmanships at the Cannabis Chemistry Sub-division of the American Chemical Society, American Herbal Products Association, ASTM D37 Cannabis Committee, and have served on other expert government advisory, trade association committees, and scientific organizations. I am currently an advisor to the State of Delaware’s Medical Marijuana Program. Attached to this letter are resources, research articles, and white papers we have authored or contributed to. This includes topics ranging from cannabinoid receptor pharmacology, drug development, CBD & THC cancer research, mental health research, and a guidance document that maybe particularly useful for your current deliberations (an FDA style 8-factor analysis of cannabis). Jan Roberts, LCSW, DSW provides IRCCMH with invaluable insights when it comes to direct clinical experience with patients. She owns and operates one of the largest collaborative care practices in the mid-Atlantic region, Partners in Health and Wellbeing. She is also one of the founders for the first integrative care center in Delaware, Integrative Health Delaware – A Center for Health & Research. Additionally, Dr. Roberts teaches at NYU Silver School of Social Work and is also working on a study of Mental Health Clinicians’ and Knowledge & Attitudes on Cannabis. Dr. Roberts was guest-editor for a special issue on Cannabis and Mental Health for the Clinical Social Work Journal. Her decision to create IRCCMH stemmed from her dedication to provide patients with the latest objective research at the therapeutic use of cannabis in mood regulation and the treatment of other mental health conditions. Dr. Roberts’ focus is on the clinical application of cannabis in mental health settings and focusing on maladaptive coping strategies rather than a substance-based approach to treating addictions. She is dedicated to educating fellow mental health clinicians on current research findings to ensure more physicians and other healthcare providers are knowledgeable about cannabis, the endocannabinoid system and the impact on mental health outcomes. In addition to her research and education endeavors, Dr. Roberts continues to treat patients. This has resulted in her firsthand knowledge of the patient safety and concern issues related to CBD products. As a result, she keenly believes that research should influence policy and not vice-versa – an important driver for IRCCMH to help contribute to informed policy decisions. Dr. Roberts is also on Governor’s appointee to the State of Delaware’s Medical Marijuana Advisory committee. The IRCCMH and I have conducted small studies aimed at assisting policymakers to make the most informed decisions. We have also advised states adopting or revising cannabis regulations. Additionally, our prior experience includes contributions to the first national standards (adopted by 19 States) for the cannabis industry with the American Herbal Products Association’s Cannabis Committee. I was also a core contributor of the American Herbal Pharmacopoeia Cannabis Monograph and co-author of a CBD Labeling study published in JAMA; this study demonstrated inaccurate labeling among the majority of tested products. Insights gained from work in these areas demonstrate the many areas warranting substantial medical research. It has also highlighted the need for clear regulations, consistent industry standards, and oversight driven by an emphasis on the public health. We urge the FDA to consider simple guidelines for hemp products, and to encourage more funding and legitimate pathways to study products that are commercially available, in the NIH or USDA budgets to fully understand and appreciate the use of cannabinoids in health and disease. We appreciate that the FDA is expediting its work to address the many questions about CBD. This is a vital national issue that directly impacts the public health. While public health must always be the driver, decisions surrounding regulations on CBD also affect multiple agencies and constituents. In the case of CBD, regulations that are holistic in their approach can certainly accomplish the FDA’s goal to protect the public health. We concur with many submitted comments provided by the public and suggest the inclusion of core guidelines in the FDA’s deliberations. These could include: 1. A pathway and guidance documents should be created for basic clinical study for any Hemp-CBD or CBD product being distributed to be on the market. 2. Education and trainings need to be available through accredited or approved organizations to help inform doctors, law enforcement, and all sectors of the cannabis and hemp industry. ISO accreditation for certifying bodies would be a simple requirement for organizations providing education or training services regarding hemp and CBD. 3. All other botanical additives should be GRAS per FDA or have safety data to support the use or inclusion in formulation 4. The product should be tested for quality, potency, and shelf-life stability according to existing standards; incorporating existing standards such as pharmacopoeias and industry consensus standards 5. The product should be tested for pesticides, heavy metals, and contaminants at laboratory with accredited methods. Thank you for the opportunity to offer our submission on this critical topic. Timely, informed and appropriate regulations can serve the public interest while requiring reasonable industry regulations to be followed. If we can be of assistance in efforts to protect the public health when it comes to cannabis, please do not hesitate to contact us as appropriate. Respectfully, Jahan Marcu, Ph.D. Chief Science Officer International Research Center on Cannabis and Mental Health 1115 Broadway, 11th Floor New York, NY 10010 Office: 917-565-9046 Selected Resources and Bibliography 1. Marcu, J. P. & Phifer, R. Alternatives to Address Cannabis Intoxication in the Workplace and Clinical Trials. The 256th American Chemical Society National Meeting Exposition (2018). 2. Russo, E. B. & Marcu, J. Cannabis Pharmacology: The Usual Suspects and a Few Promising Leads. Adv Pharmacol 80, 67–134 (2017). (Attached) 3. Bonn-Miller, M. O. et al. Labeling Accuracy of Cannabidiol Extracts Sold Online. Jama 318, 1708–1709 (2017). (Attached) 4. Marcu, J. P. An Overview of Major and Minor Phytocannabinoids. Neuropathology of Drug Addiction and Substance Misuse 672 678 (2016). doi:10.1016/b978-0-12-800213-1.00062-6 5. Marcu, J. P. Scheduling Cannabis: A Preparatory Document For FDA’S 8 Factor Analysis On Cannabis. (2016). (Attached) 6. Shore, D. et al. Allosteric modulation of a cannabinoid G protein-coupled receptor: binding site elucidation and relationship to G protein signaling. J Biol Chem 289, 5828 5845 (2014). 7. Marcu, J. et al. Novel Insights into CB1 Cannabinoid Receptor Signaling: A Key Interaction Identified between the Extracellular-3 Loop and Transmembrane Helix 2. J Pharmacol Exp Ther 345, 189–197 (2013). 8. Marcu, J. P. et al. Cannabidiol enhances the inhibitory effects of delta9-tetrahydrocannabinol on human glioblastoma cell proliferation and survival. Mol Cancer Ther 9, 180 189 (2010). 9. Marcu, J., Console-Bram, L. & Abood, M. E. Current
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