Dr. Willie McKinney spoke at the Cannabis Science Conference.

Thank you for the warm introduction. I’d like to start by expressing my gratitude to the organizers of the Cannabis Science Conference for inviting me to speak today. I must mention that I woke up this morning with my voice not quite at its best, so we’ve been arguing all day, but I hope you can hear and understand me clearly. I may not be as animated as usual.

Regarding the presentation, if you’ve read the abstract, you’ll notice that what I’ll be discussing is slightly different. I’ve prepared an agenda, but my primary focus will be on the similarities between the tobacco and nicotine industries and how the cannabis industry can leverage learnings from these sectors.

Let’s begin with the products. There are many similarities between tobacco and cannabis products. For example, both industries have inhalable, combustible, and oil-based products. Cannabis has ingestibles, while nicotine does not, and both have pharmaceutical applications. However, I won’t discuss pharmaceuticals as there’s a clear regulatory pathway for those, regardless of whether it’s for cannabis or tobacco products.

I’d also like to make a controversial statement: there’s no such thing as medical cannabis. We can discuss this further, and I encourage you to read an article on this topic on our website.

Firstly, let’s talk about policy. One important aspect to understand is that policy can be influenced by the actions of a few companies, creating what we call a moral panic. Looking at the nicotine industry, we saw a significant increase in middle and high school students using e-vapor products around 2017-2018. This led to public outcry, prompting local congress members and the FDA to act. The result was a de facto ban on flavored pods, as these were identified as products primarily used by minors.

This reaction by the FDA was effective, but it also triggered state governments to take action. Unlike the federal government, states acted quickly and often implemented broader bans on flavored e-vapes. This ongoing situation is an important lesson for the cannabis industry.

In the cannabis space, there’s been a notable increase in calls to poison control centers regarding children being exposed to cannabis products, particularly edibles. Although this hasn’t reached the level of a moral panic yet, it’s something to watch closely. The FDA has already sent warning letters to companies illegally selling copycat food products containing delta-8 THC. The industry should learn from the tobacco sector and avoid creating a moral panic.

Regulators have many questions about cannabis products, similar to their initial concerns with nicotine. These include understanding the potential harms, side effects, exposure levels, usage patterns, and the impact of high THC concentrations. Questions also cover addiction, lung health, and the presence of contaminants. Nicotine products required extensive testing before being authorized, and similar rigorous standards are likely to be applied to cannabis products.

When it comes to generating scientific data for regulatory submissions, consider the nicotine industry. Companies were given two years to prepare their applications, including comprehensive data on chemical characterization, toxicology, risk assessments, human studies, and behavioral impacts. Many companies underestimated the time and resources required, leading to a high percentage of applications being refused or denied.

To illustrate, out of 26 million products submitted, 74% were refused to accept, meaning those products had to be removed from the market. Only 31 marketing orders were granted, all to major tobacco companies. This highlights the importance of being prepared and generating robust, reliable scientific data.

In conclusion, the cannabis industry should anticipate similar regulatory scrutiny and start preparing now. By learning from the nicotine sector, cannabis companies can ensure they have the necessary data to defend their products and remain compliant with future regulations.

Thank you for your attention. I’ve delivered my message in 30 minutes, as promised. If you have any questions, I’ll be happy to answer them now.