The Department of Justice and Drug Enforcement Agency should reclassify marijuana from Schedule I to Schedule III to allow consideration of the health, safety, and abuse liability impacts of cannabis and tobacco co-use along with cannabis use alone

On July 22, 2024 the CTCRE submitted the following public comment. The Regulations.gov Comment Tracking Number is lyx-czau-7oaf. A PDF of the comment can be downloaded here.

The Department of Justice and Drug Enforcement Agency should reclassify marijuana from Schedule I to Schedule III to allow consideration of the health, safety, and abuse liability impacts of cannabis and tobacco co-use along with cannabis use alone and proactively identify regulatory approaches from tobacco product regulation that can be applied to cannabis regulations

Docket Number DEA-1362

Pamela M. Ling, MD, MPH; Stanton A. Glantz, PhD; Lauren K. Lempert, JD, MPH; 
Stella Aguinaga Bialous, DrPH, FAAN; Bonnie Halpern-Felsher, PhD*; 
Matthew L. Springer, PhD; Nhung Nguyen, PhD;  
Benjamin W. Chaffee, DDS MPH PhD; Neal L. Benowitz, MD; Dorie E. Apollonio, PhD, MPP

University of California San Francisco

*UCSF and Stanford University    

July 22, 2024 

 

We support the Department of Justice proposal to transfer “marijuana” (we prefer to use the term “cannabis”) from Schedule I to Schedule III of the Controlled Substances Act to allow better definition of evidence-based medical usages.  The current assignment of marijuana to Schedule I makes it exceptionally difficult to conduct meaningful medical research about the health effects (both positive and negative) of cannabis use.[1]  This situation allows unsubstantiated health claims for cannabis use to go unchallenged and makes it exceptionally difficult to identify specific therapeutic uses for cannabis, appropriate indications, and dosing.  This evidence vacuum supports widespread use of cannabis for perceived health indications without a scientific basis. In addition, moving cannabis to Schedule III will facilitate development of effective regulatory strategies, which should take into account the interactions between cannabis and tobacco.

The cannabis/tobacco cross-over

Our research has shown that cannabis and cannabis-tobacco co-use is a significant public health issue that must be addressed at the federal level. Therefore, we believe that as part of the regulatory decision-making process, DEA, DOJ, FDA, HHS, and other federal agencies should consider cannabis and tobacco co-use along with cannabis use alone when weighing the potential for therapeutic benefits against the potential for health, safety, and abuse liability harms. Further, our own research supports the view that all federal agencies should apply best practices from tobacco regulation and lessons learned from tobacco regulatory science to inform future cannabis regulation.

1. DEA, DOJ, HHS, FDA, and other federal agencies must consider the individual and additive health effects of tobacco and cannabis co-use in all its decision-making, and
2. DEA and DOJ should proactively identify best practices from tobacco regulatory science that can inform cannabis regulation.  

Moving cannabis from Schedule I to Schedule III will facilitate coordination among DEA, DOJ, HHS, FDA, and other federal agencies in order to proactively evaluate the interaction between cannabis and tobacco, identify best practices from tobacco product regulation, and determine what can and should be applied to cannabis regulation.

1. While cigarette smoking rates are falling,[2] cannabis use rates are increasing among adults and youth.[3]^,[4]Tobacco and cannabis co-use is common, with Wave 2 of FDA’s PATH study showing more than 21% of all young adults reported currently using both cannabis and tobacco in the past month.[5] In Wave 4 of the PATH study, 28%-48% of those who use tobacco were also using cannabis.[6] E-cigarette use more than triples the odds of cannabis use.[7] In addition to THC-containing products, in 2022 more than 1 in 5 adolescent e-cigarette users reported current past-month CBD vaping, with higher rates among Hispanic and sexual and gender minority youth.[8]  
2. Tobacco and cannabis co-users are more likely to use tobacco (and cannabis) products heavily, develop dependence, have greater nicotine dependence^,[9] exhibit problem behaviors related to cannabis use, and poorer cessation outcomes for tobacco and cannabis[10] than single product users.[11] Co-use also presents additive psychiatric, psychosocial, mental health disorders, and toxicological risks^{.[12],[13],[14],[15],[16]}
3. Cannabis use and exposure to cannabis smoke are increasingly perceived as safe.[17] However, tobacco and cannabis smoke share many chemical compounds that are known carcinogens, and smoking cannabis is associated with increased risk of head/neck cancers and other cancers.[18] Though less research has been done on cannabis, studies have found combustion of cannabis, whether through smoking or vaping, produces a greater amount of particulate matter than tobacco, raising concerns that exposure to cannabis smoke or aerosols could have similar health consequences.[19]^{,[20],[21],[22],[23],[24]}  
4. The evolving tobacco marketplace affects the cannabis market. The exploding popularity of nicotine vaping[25]was accompanied by a parallel increase in cannabis vaping among youth.[26] Furthermore, tobacco product regulations such as prohibition of flavored products open market opportunities for cannabis products such as flavored CBD vapes, which have begun to appear in nicotine vape shops.[27] DEA, DOJ, FDA, and other federal agencies need to take into account the increases in cannabis and CBD use as a (unintended) consequence of tobacco product regulation. 
5. On August 23, 2023 FDA’s Center for Tobacco Products (CTP) issued warning letters[28] to 15 online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like youth-appealing characters, school supplies, toys, and drinks. Simple web searching revealed it was not difficult to find examples of cannabis products closely matching the images from the FDA’s announcement. This suggests that the youth-targeted marketing for e-cigarettes is also happening for cannabis products. DEA and DOJ should leverage CTP’s experience in this area to inform regulations related to cannabis products.
6. On the following pages we present examples of cannabis products that use images that closely match the images of e-cigarettes products that were the target of FDA’s announcement. On the left are the images from the FDA announcement, and on the right we present cannabis products with similar packaging.  Sources for these images are listed below the chart:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Image Sources:

 

https://www.eater.com/2016/10/25/13402724/starbucks-bong-lawsuit-trademark

https://www.dhgate.com/product/jack-in-the-box-burger-king-glass-mcdonalds/371720809.html

https://pilotdiarystore.com/products/poto-water-bottle-bong?variant=39747209396324

https://inhalco.com/blogs/guides/8-best-spongebob-bongs

https://hazebongshop.com/products/11-5-adorable-fuzzy-bear-bong

https://www.eightcig.com/wizvapor-stoned-boy-alternative-vaporizer/

https://www.elementvape.com/canna-river-d8-d10-disposable

https://delta8resellers.com/product/flying-monkey-heavy-hitter-disposable-2g/

https://www.luvbrite.com/product/mario-carts-strawberry-pie-1g

 

7. In addition, FDA’s experience with tobacco regulatory science including safety assessment and health impact of product use is highly relevant to these crossover and co-used products, so DEA and DOJ should use these experiences to help inform their own regulatory decision-makin Many studies of tobacco perceptions (including the PATH study) and health effects already include cannabis measures or can be adapted to cannabis products. Lessons learned from the EVALI outbreak can be applied to address cannabis vaping products (e.g., delta-8-THC-O acetate) that hold similar health risks.[29] DEA and DOJ should leverage this opportunity to address tobacco and cannabis co-use.
8. Best practices from tobacco control should be applied to cannabis regulation because tobacco companies are entering the cannabis marketplace.  The cannabis industry seeks to influence policy to increase cannabis consumption similar to past tobacco industry efforts.[30] In 2019, Philip Morris bought a 45% stake in Cronos, which sells loose-leaf cannabis, joints, flavored cannabis oils, vape pens, edibles, tinctures, and lotions,[31] and in 2021 its parent company Altria registered to lobby on cannabis issues.[32] In 2021, British American Tobacco (parent of Reynolds American in the US) began selling a flavored CBD vape (Vuse CBD, formerly Vype) as its formal entry into the cannabis market.[33]  Marketing cannabis products allows tobacco companies to integrate cannabis into existing tobacco corporate social responsibility and “harm reduction” platforms, building on the perception of cannabis as a medical product,[34] and facilitates cannabis industry use of tobacco industry tactics to influence policy.[35]

1. Lessons learned from tobacco product regulation that can be readily applied to cannabis include:
   • Prohibition of unsubstantiated health claims
   • Limitations on advertising and packaging that appeal to youth
   • Implementing effective warning labels
   • Prohibiting product formulations that increase health risks
   • Prohibiting flavors, including menthol, in combustible and vaporized products
   • Recognizing the problem of conflicts of interest and acting to prevent regulators and public employees from having conflicts of interest with the cannabis industry.
   • Establish product standards to regulate manufacturing, marketing, and sale of products.
2. DEA and DOJ should translate the evidence-based and effective tobacco control principles and practices to inform cannabis regulation. 

 

As part of the process to reschedule cannabis, DEA and DOJ should identify best practices from tobacco control and tobacco regulation to inform a comprehensive regulatory regime for cannabis. To protect public health, if cannabis is rescheduled from Schedule I to Schedule III, it should be subject to a robust demand reduction program modeled on successful evidence-based tobacco control programs. A key goal of the public health framework would be to make it harder for a new, wealthy, and powerful cannabis industry to manipulate the policy environment and thwart public health efforts to minimize use, exposure, and associated health problems.[36]