National Cannabis Industry Association’s Response to the U.S. Food and Drug Administration’s Request for Public Comments on Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds May 2019 National Cannabis Industry Association INDUS ABIS TR N Y N AS A S C O L C A I N A T O I I O T N ADVOCACY. EDUCATION. COMMUNITY. A N T h g e r C .o an try nabisIndus May 31, 2019 INDUS ABIS TR N Y N AS A S Food and Drug Administration C O L C A I Division of Dockets Management N A T O I I O Docket FDA-2019-N-1482 T N A HFA-305 N 5630 Fishers Lane T h g Room 1061 e r C .o Rockville, MD 20852 an try nabisIndus Re: Public Comments Submission (Docket FDA-2019-N-1482) Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds Dear Sir/Madam: On behalf of the National Cannabis Industry Association (“NCIA”), and in response to the U.S. Food and Drug Administration’s (“FDA”) request for comments on Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds, published in the April 3, 2019 edition of the Federal Register, we hereby submit the attached public comments and relevant prior work. In addition to our specific expertise, and on behalf of our Association members and the cannabis and CBD/hemp industries at large, we have formed a coalition of cannabidiol (“CBD”)/hemp entrepreneurs, scientists, medical professionals, and food and drug lawyers to provide public comment to FDA and to answer specific questions posed by FDA, to provide general context about the industry, and to highlight work that we have previously done on packaging, labeling, and lab testing that could inform FDA rulemaking. This coalition was formed for the sole purpose of providing public comments to FDA. Coalition ​ ​ members have collaborated for weeks to prepare this submission and are listed below. We are grateful that FDA is accepting public comments from the CBD/hemp industry and interested parties. As leading advocates for this nascent industry, NCIA looks forward to providing useful information to help inform FDA in their rulemaking process. Today, NCIA represents nearly 2,000 members, including CBD-related commercial manufacturers, as well as cannabis and ancillary business leaders, legal professionals, specialized researchers and scientists, and public health experts throughout the United States. Because of our diverse membership, NCIA is uniquely positioned to provide recommendations to FDA that address potential benefits and industry standards for regulatory oversight of products containing cannabis or cannabis-derived compounds. Given the substantial interest in this topic and the need for regulations and standardization throughout the industry, NCIA and this coalition are providing specific insight into all facets FDA would like to examine, including health and safety risks, manufacturing and product quality, and marketing, labeling, and sales. Additionally, NCIA and our coalition have expert 2 knowledge and access to relevant information to inform FDA as it considers proper regulations overseeing cannabis-derived compounds to ensure product quality and consistency. As consumption of CBD and the popularity of other hemp-related materials has dramatically increased in recent years, NCIA is the leading organization to inform appropriate regulators about cannabis-derived products under the purview of FDA. We are committed to continuing to work with Federal regulators, Congress, and State and local stakeholders to implement effective regulations supported by in-depth research, analysis, and input from diverse stakeholders and experts. NCIA and our coalition appreciate the opportunity to provide written comments to FDA on such an important topic and we thank you in advance for considering our expert views. We look forward to working with FDA to implement regulations and improve public safety for the cannabis and cannabis-derived products marketplace. If you have any questions regarding our submission or would like further information, please feel to contact NCIA’s Director of Public Policy, Andrew Kline, at (720) 547-6218 or ​ ​ [email protected]. Sincerely, Aaron Smith Andrew Kline Executive Director Director of Public Policy National Cannabis Industry Association National Cannabis Industry Association Khurshid Khoja Henry G. Wykowski, Esq. Principal, Greenbridge Corporate Counsel Wykowski Law Board Vice Chair, National Cannabis Industry General Counsel to the National Cannabis Association Industry Association Alena Rodriguez Jonathan Havens Managing Director Partner | Co-Chair, Cannabis Law | Chair, Rm3 Labs Food & Beverage 3 Saul Ewing Arnstein & Lehr LLP Dr. Paul Muchowski Andrew Livingston CEO and Founder Vice President, Research and Analysis Dr. Paul’s VS Strategies Étienne Fontán Jessica Billingsley Vice President Co-Founder & CEO Berkeley Patients Group MJ Freeway AC Braddock Steve DeAngelo CEO Chairman Emeritus Eden Labs LLC Harborside / FLRish, Inc. Eduardo Provencio Jeremy Riggle, Ph.D. General Counsel Chief Science Officer Mary’s Medicinals Mary’s Medicinals Douglas Fischer Joseph W. Hickey Sr. General Counsel Founding Board Member Greenlane Holdings Kentucky Hemp Industries Association Chris Elawar Vanessa Marquez Co-founder Co-founder CBD Care Garden CBD Care Garden 4 Adam Orens Alex Berger Economist - Founder Attorney Marijuana Policy Group Emerge Law Group James Schwartz BSN, LNC Stuart Bennett CEO Chief Revenue Officer Cascade High Organics Gabriella’s Kitchen, Global Lab Analytics Jessica Wasserman. Esq. Michael Scherr Partner CEO & Founder Greenspoon Marder LLP Aria Brands Richard Y. Cheng, JD, CHC Ian Stewart Partner, Health Care Industry Sector Wilson Elser Moskowitz Edelman & Dicker DLA Piper, LLP LLP Dr. Theodore Search Tyler Williams Medical Advisor VP of Operations GoFire ASI Cannabis Safety and Quality Jason Winkler Ramon Alarcon President CEO Novium Wellness Insight Technologies, Inc 5 Jarett Burke Gregg Steinberg CEO CEO Jade House Midwest GrowCentia Susan Ameel Josh Levine Global Regulatory Risk Advisors, LLC Global Regulatory Risk Advisors, LLC Christina Sasser Randy Miles CEO Total Cannabis Solutions Vital Leaf Michael Cooper Tom Downey Managing Member Attorney MadisonJay Solutions LLC Ireland Stapleton Pryor and Pascoe, PC Daniel Smith Dylan C. Summers Vice President, State and Federal Policy Chief Marketing Officer VS Strategies Lazarus Naturals Steven Hawkins Herrick Fox Executive Director CEO and Co-Founder Marijuana Policy Project Meristem Farms, LLC 6 Robert Gold Steve Goldner Managing Attorney CEO and Founder AEGIS Law Pure Green Colte Koen Arnaud Dumas de Rauly CEO Co-CEO of The Blinc Group Hempsun Farms Products Chairman of the ISO Standards on Vaping Thomas Caristo Joshua Awad TEQ Analytical Labs Co-Founder and COO Honest Paws Corey Pease Mike LeBlanc CEO Chief of Brand Development Holistic Hemp Healing Chae Manufacturing Elisa J. Stewart, Esq. Andrew Schwartz, Ph.D. Chief Compliance Officer Co-Founder Greenbrier Holdings, LLC Mokiobi Tess Melody Taylor Jillian Hishaw TAYLOR + tess Founder/Director, Family Agriculture Resource Management Service (F.A.R.M.S.) 7 Gregory Candelario Alex Buscher CEO & Founder Founding Attorney Tissue Culture Research & Development Buscher Law LLC Mark Caredda Hillary King Bucklin Chief Operating Officer Owner Hemp Hydrate International Holdings Ltd. H. King & Co. Simon Dufour Susan Agostinelli Principal President & CEO Hall & Company Certified Public Accountants Pure Hermosa Shira Adler Crystal A. Banse Founder & CEO Founder & CEO Synergy by Shira Adler Banse Law Group Elisa J. Stewart, Esq. Pamela N. Epstein Chief Compliance Officer CEO Greenbrier Holdings, LLC Green Wise Consulting Daniel D. Waite Bryna Dahlin CEO/Founder Partner Live Well Organix, LLC Flener IP & Business Law 8 Susan Ameel Josh Levine Founder and Partner Founder and Partner Global Regulatory Risk Advisors, LLC Global Regulatory Risk Advisors, LLC Jessica Passman, Esq. Bryan Passman Founder and COO Founder and CEO Hunter + Esquire Hunter + Esquire Nathan Howard Peter Belsito Co-founder & President CEO & Co-Founder East Fork Cultivars 3BC LLC Alan Hofman Matt Locati COO Managing Member GreenRx-id Cannalytics Capital LLC Mark Passerini Manndie Tingler, M.S. Co-Founder Chief Executive Officer The Om of Medicine Silver Leaf Events Kimberly Ross, PhD Chief Compliance Officer Peak Compliance 9 National Cannabis Industry Association (NCIA) FDA Public Comments Submission (Docket FDA-2019-N-1482) TABLE OF CONTENTS Introduction ........................................................................ 11 Questions Posed by FDA ........................................................................ 15 Health and Safety Risks ........................................................................ 15 Question 1 ........................................................................ 15 Question 2 ........................................................................ 21 Question 3 ........................................................................ 22 Question 4 ........................................................................ 23 Question 5 ........................................................................ 24 Question 6 ........................................................................ 25 Manufacturing and Product Quality ........................................................................ 27 Question 1 ........................................................................ 27 Question