Policy Council Conversations | 7.20.21 | The Medicine and Research of Cannabis
In this edition of our Policy Council Conversations series originally aired on Tuesday, July 20, 2021 we were joined by the six primary authors of NCIA’s recently released whitepaper on the Medicine of Cannabis for an overview designed to help inform and guide policymakers and medical professionals on the science, history, and uses of medical cannabis.
The Medicine of Cannabis: An Overview for Medical Professionals and Policymakers – https://bit.ly/3Bn1UBy
This publication was developed by scientists and doctors working with NCIA’s Policy Council and Scientific Advisory Committee, and promotes policies that facilitate further research and fair, legal access. On this webinar you’ll hear from the writing team itself, including physicians, veterinarians, and a PhD researcher as they discuss their paper and summarize what your doctor and policy maker needs to know.
Learning Objectives:
• Overview the history of medical cannabis and its prohibition in the United States
• Brief intro to the Endocannabinoid System
• Explore the cannabis plant
• Learn about different conditions cannabis can treat and the research that backs it up
• Discuss policy implications for cannabis including the need to deschedule
Speakers:
• Dr. Stephen Dahmer MD, Chief Medical Officer, Vireo Health
• Dr. Paloma Lehfeldt MD, Director of Medical Education, Vireo Health
• Dr. Paul Muchowski PhD, Founder/CEO/CSO, Defined Research
• Dr. Lynn Parodneck MD, Medical Practitioner
• Dr. Tim Shu DVM, CEO, VETCBD
• Dr. Casara Andre DVM, Founder, Veterinary Cannabis Education & Consulting
U.S. Supreme Court Refuses to Hear Landmark Cannabis Case
On Tuesday, the U.S. Supreme Court refused to hear a prominent case, Washington v. Barr, which argued that cannabis prohibition is unconstitutional. This action in effect upholds an earlier district court ruling which said that the plaintiffs – who included a former NFL player, a veteran, pediatric cannabis patients and advocacy organizations – had not exhausted all administrative remedies available to them to change the schedule of cannabis in the Controlled Substances Act.
Last month, the law firm of Wilson Elser filed an amicus brief on behalf of NCIA and Arcview which argued that the court should proceed with the case because the historical behavior of the Drug Enforcement Administration made pursuing the remedies sought in the case through administrative means practically impossible. You can read the full brief here.
“We were disappointed that the Supreme Court declined the opportunity to address this critical issue,” said amicus contributor Michael Cooper with MadisonJay Solutions, who is the co-chair of NCIA’s Policy Council and chair emeritus of its State Regulations Committee. “As the leading non-profit trade association for the cannabis industry, we urged the Supreme Court to protect the countless Americans who rely on state-regulated cannabis programs and the small businesses that support them. We will continue to work on behalf of our members to end prohibition, whether by continuing to support crucial impact litigation such as this or through NCIA’s team of full-time government relations professionals who continue tirelessly to advocate for reform through Congress and the Executive.”
Politicoreports that the lead attorney for the plaintiffs, Michael Hiller, is continuing to explore options for appeal.
Webinar: Policy Council Conversations: Just Say No – Keep the DEA out of Cannabis Research
NCIA’s #IndustryEssentials educational webinar series is our new digital platform featuring a variety of programs to provide you timely, engaging, and essential education when & where you need it most!
The Policy Council Conversations series features insights & invaluable content directly from members of NCIA’s Policy Council, the preeminent “Think Tank” for the cannabis industry.
The Drug Enforcement Administration recently issued a notice of proposed rulemaking on cannabis research. If adopted, this rule would fundamentally change how cannabis research is conducted. NCIA recently submitted public comments, rejecting the DEA’s power grab and strongly suggesting that a public health agency (i.e. Health and Human Services, National Institutes of Health, etc.) lead on cannabis research. Simultaneously, lawyers at Yetter Coleman filed a Freedom of Information Act lawsuit against DOJ, demanding the release of an OLC memo relied upon by DEA in their rulemaking. That successful suit was brought on behalf of Scottsdale Research Institute.
This panel will discuss the critical importance of cannabis research, the DEA rulemaking and NCIA’s numerous objections, and the lawsuit against DEA and the resulting disclosure of the DOJ policy memo.
Register now to join us on Wednesday, June 3 at 12:00 PM MT.
Jodi Avergun
Chair, White Collar and Criminal Defense and Investigations Group
Cadwalader, Wickersham & Taft LLP
&
Former Chief of Staff
Drug Enforcement Administration (DEA)
Andrew Kline
Director of Public Policy
National Cannabis Industry Association
Sue Sisley, MD
Principal Investigator
Scottsdale Research Institute
Matt Zorn
Associate
Yetter Coleman
Shane Pennington
Associate
Yetter Coleman
How Will The Federal Government Regulate Cannabis? We Have a Plan.
by Andrew Kline, NCIA’s Director of Public Policy
NCIA could not be more proud of the collective efforts of the cannabis industry in passing SAFE Banking legislation in the House. Last week was a truly historic moment for the industry. Now, on to the Senate!
While we always relish in victories, we can’t lose momentum, and we need to start thinking about what comes next. As luck (and a bit of hard work) would have it, NCIA has a plan. While NCIA has been fully supportive of incremental steps like SAFE Banking, we believe that the only long-term viable path forward for this industry is descheduling. It’s the only way to solve social equity, it’s the best way to fix 280E, it’s the way that we start looking at cannabis through a public health lens (instead of a criminal enforcement lens), it fixes issues around interstate commerce, and it’s the only way to end the unsustainable federalism clash.
In addition to de-scheduling, our plan calls for cannabis products, like other highly regulated consumables, to be regulated by the government agencies that currently regulate most food and drugs, primarily the Food and Drug Administration (FDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB) within the U.S. Department of the Treasury.
Under our plan, cannabis products would be divided into four categories, based on chemical components, safety, intended use, and consumption method. Each of these groups would be regulated through a separate regulatory “lane” tailored to the public policy issues raised by that particular classification. The four lanes are:
Lane #1 — Pharmaceutical drugs (e.g., Epidiolex; Marinol)
(Regulated Like Prescription/OTC Drugs; Lead Federal Regulator: FDA)
Lane #2 — Ingested, inhaled, or topically applied products with more than de minimis amounts of THC (+0.3%)
(Regulated Like Alcohol; Lead Federal Regulator: TTB)
Lane #3 — Ingested and inhaled products with de minimis amounts of THC (<0.3% THC) (e.g., CBD, CBN, and CBG)
(Regulated Like Food/Dietary Supplements; Lead Regulator: FDA)
Lane #4 — Topically applied products with de minimis amounts of THC (<0.3% THC) (e.g., CBD, CBN, and CBG topicals)
(Regulated Like Cosmetics; Lead Federal Regulator: FDA)
Photo By CannabisCamera.com
We firmly believe that our plan sets the stage for the weeks and months ahead. We hope that lawmakers will heed our call for de-scheduling and federal regulation. There is no other viable option for the burgeoning cannabis industry. As always, NCIA stands ready to provide technical assistance to lawmakers and to the Executive Branch as we forge ahead. There is no stopping us now.
If you’re interested in working on public policy issues like this one, please reach out to me to inquire about the Policy Council. We are the think tank for cannabis and we’re just getting started.
In April of 2019, the National Cannabis Industry Association (NCIA) formed a coalition of more than 100 CBD/Hemp entrepreneurs, scientists, medical doctors, and FDA lawyers to inform and influence FDA rulemaking on cannabis and cannabis-derived compounds. Over the past two months, coalition members worked tirelessly to draft public comments. Our goal was to answer all of the questions posed by FDA (including scientific questions), to be helpful to FDA by informing their rule-making process, and to influence the direction of their rule-making.
NCIA Files Public Comment And Testimony
On May 30, 2019, we filed 60 pages of formal comments which can be found here. I’m really grateful for the coalition’s collaborative work and quite proud of our final product. I’m also extremely grateful to the authors, including Alena Rodriguez of RM3 Labs, Dr. Paul Murchowski of Dr. Pauls, Khurshid Khoja of Greenbridge Corporate Counsel, Vanessa Marquez and Chris Elawar of CBD Care Garden, Jonathan Havens from Saul Ewing, Andrew Livingston from VS Strategies, and many others who devoted time to produce a great submission.
On May 31, I testified before the FDA and listened intently as dozens of others spoke. My takeaways were that most of the industry echoed our sentiment – that CBD is generally safe, but that safety issues do arise with adulterated products and with irresponsible manufacturing and marketing practices. I spoke about the need for consensus-driven industry standards, to include marketing and labeling practices, and for mandated lab testing. These practices will go a long way toward making certain that the industry is safe for consumers.
Concerns And Misinformation
I am genuinely concerned that there is currently great confusion in the market. People seem to think that CBD is federally legal as a result of passage of the Farm Bill of 2019. But, that is only partially true. While CBD was de-scheduled, the FDA still retains the authority to regulate the industry as a result of their prior approval of a prescription drug for epilepsy, Epidiolex. In the absence of clear regulatory guidance, people are making health claims that violate federal law. And banks and payment processors are shutting off accounts for CBD businesses because they are having difficulty assessing whether a particular business is operating lawfully.
We hope that FDA will act with deliberate speed in drafting regulations for the industry. If FDA takes its time in crafting regulations, there is danger that many CBD companies will shudder because of a lack of banking and payment processing. And we will inevitably lose market share to Canada and other international players. As always, NCIA stands ready to help.
Learning objectives for the panel include, (1) what the FDA was interested in learning about and why, (2) understanding how our industry coalition responded to the FDA’s scientific questions, (3) predictions for how the FDA will regulate CBD/Hemp and what it might mean for cannabis regulation in the future. Panelists will include members of the coalition who drafted our public comments to FDA.
In the coming weeks, NCIA will be releasing some new policy papers via NCIA’s Policy Council – the think tank for the state-legal cannabis industry. As always, if you’re interested in joining the Policy Council or have any thoughts about how we can propel this industry, please reach out me at andrew@thecannabisindustry.org.
Policy Council: The Little-Known – And Critical – Exception To Federal Paraphernalia Laws
This paper was generated by NCIA’s Policy Council. Steve Fox, Policy Council Director, says “the mission of NCIA’s Policy Council is to inform lawmakers and other stakeholders about policy-related matter affecting the cannabis industry. This short paper is an excellent example of that type of work. It is important that we raise awareness about the critical exception to federal paraphernalia laws, under which state-authorized activity is exempt from the provisions of the law. We can debate how that exemption should be interpreted, but we must acknowledge that it exists. This paper furthers that goal.”
Policy Council: IRC Section 280E – An Unjust Burden on State-Legal Cannabis Businesses
NCIA’s Policy Council, comprised of industry leaders selected by NCIA’s Board of Directors, play a critical role in the development of cannabis policy at the federal level. The Policy Council recently produced a white paper titled “IRC Section 280E: An Unjust Burden on State-Legal Cannabis Businesses” which is now available in an easy-to-read design with the intention of utilizing this in conversations with policymakers, the media, and the industry.
“Fixing Section 280E of the Internal Revenue Code has been a policy priority for NCIA since its founding in 2010,” said Steve Fox, co-founder of NCIA and director of the Policy Council. “It is therefore appropriate that the fist Policy Council paper is focused on this issue. The information contained in this paper will be useful in lobbying efforts as Congress continues to debate tax reform. In particular, the projections contained in the paper, showing that reforming 280E could actually result in a net increase in tax revenue for the federal government, should be especially eye-opening.”
