CTP should actively integrate the relationship between cannabis and tobacco use into its tobacco regulation and proactively identify regulatory approaches from tobacco product regulation that can be applied to cannabis

We submitted this comment to the FDA on August 25, 2023. The Regulations.gov tracking number is : llr-ce58-0gi0. A PDF copy is available for download here.

 

CTP should actively integrate the relationship between cannabis and tobacco use into its tobacco regulation and proactively identify regulatory approaches from tobacco product regulation that can be applied to cannabis

 

 

 

Docket No. FDA–2023–N–2873

 Developing FDA’s Center for Tobacco Products’ Strategic Plan

 

 

Pamela M. Ling, MD, MPH; Nhung Nguyen, PhD; Neal L. Benowitz, MD;

Lauren Kass Lempert, JD, MPH; Stanton A. Glantz, PhD; Matthew L. Springer, PhD;

Leila Mohammadi, MD, PhD; Bonnie Halpern-Felsher, PhD;

Benjamin W. Chaffee, DDS MPH PhD; Sabrina Islam, PhD;

Vira Pravosud, PhD; Hai-Yen Sung, PhD; Dorie Apollonio, PhD, MPP;

Stella Aguinaga Bialous, DrPH; Wendy Max, PhD; Janet Wojcicki, PhD, MPH;

Karla Llanes, PhD; Yingning Wang, PhD; Michael A. Matthay, MD; Minji Kim, PhD*; 

 

UCSF TCORS

*University of South Carolina

 

August 25, 2023

 

FDA announced[1] a Public Meeting and Listening Session and an opportunity to submit written public comments to obtain feedback on five proposed strategic goals it is using to develop a strategic plan for FDA’s Center for Tobacco Products’ (CTP) comprehensive Strategic Plan. In addition, CTP asked for comment on the question, “Are there any important features, activities, or initiatives not encapsulated by these proposed goal areas that you believe CTP should consider as part of its strategic plan?”  One important activity not included in the proposed goals is to integrate impact of cannabis and cannabis-tobacco co-use on tobacco product regulation, and conversely, to apply best practices from tobacco regulation and lessons learned from tobacco regulatory science to inform future cannabis regulation.

 

1. The Center for Tobacco Products must consider the individual and additive health effects of tobacco and cannabis co-use in all its decision-making, and

 

2. The Center for Tobacco Product strategic plan should include proactive identification of best practices from tobacco regulatory science that can inform cannabis regulation.  

 

While cannabis is not included under CTP’s current regulatory authority, the FDA requested scientific data and information about cannabis in 2019, and CTP should proactively integrate the interaction between cannabis and tobacco and identify best practices from tobacco product regulation that can 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 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 it 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]  FDA needs 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 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.  CTP’s experience in this area is well suited to apply to cannabis products.
6. On the following pages we present examples of cannabis products 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

 

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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.  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., delta-8-THC-O acetate) that hold similar health risks.[29] FDA should leverage this opportunity to address tobacco and cannabis co-use.
8. Lessons learned from tobacco product regulation that can be readily applied to cannabis include:
   1. Prohibition of unsubstantiated health claims
   2. Limitations on advertising and packaging that appeal to youth
   3. Implementing effective warning labels
   4. Prohibiting product formulations that increase health risks
   5. Prohibiting menthol and other flavors in combustible and vaporized products
   6. Recognizing problem of conflicts of interest and acting to prevent regulators and public employees from having conflicts of interest in the cannabis industry.
   7. Establish product standards to regulate manufacturing, marketing, and sale of products.

 

3. Regardless of which division or agency ultimately obtains regulatory authority over cannabis, FDA should translate evidence-based and effective tobacco control principles and practices to inform cannabis regulation.

 

As part of its strategic plan, FDA CTP should identify best practices from tobacco control and tobacco regulation to inform a comprehensive regulatory regime for cannabis.  To protect public health, if cannabis becomes legal 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 and associated health problems.[30]