Industry Insights
Aug 2, 2023
Courtney Stough

Navigating the FDA's Shifting Stance on Cannabis & Psychedelics

The world of cannabis and psychedelics is changing fast, with new research and attitudes driving the evolution.  We talked in a recent Insight about how HHS Secretary Becerra might present a review of cannabis as a Schedule I substance by year-end and that the FDA faces a tricky task regulating cannabis because of its diverse therapeutic molecules. We’ve made the claim before (that some see as bold) that psychedelics in this country will be federally legal prior to cannabis due to the fact the FDA is set up to regulate single molecules for single therapies, and because cannabis isn’t that, cannabis will take longer.

In fact, the HHS’s review of cannabis potentially getting reclassified (which would then turn into a recommendation made to the White House) is still so nebulous that Congressional Representatives including Matt Gaetz pressed DEA Administrator Anne Milgram last week on the timing of the review which she does not control (and is not undertaking at the current moment) in a hearing last week.

But guess what? The FDA (in guidance published at the end of June and open for public comment until August 25th) has already dropped new guidelines on psychedelics research, highlighting how the agency’s evolving stance on mono-molecule psychedelics might pave a smoother path to regulation.

Are psychedelics going to leapfrog cannabis and get legalized sooner? Seems like they're gaining momentum with the FDA’s “Breakthrough Therapy” designation and shifting public opinion. The signs are there that psychedelics will be mainstream more quickly.

Cannabis Regulation: A Delicate Balance

The FDA has traditionally approached cannabis with caution, maintaining its classification as a Schedule I substance at the federal level, despite its widespread state legalization. Acknowledging the need for evidence-based research, as discussed in our prior Insight, the FDA has focused on individual components of cannabis, such as CBD, exemplified by the approval of Epidiolex, an FDA-approved CBD-based medication, for specific medical conditions. This measured approach aims to strike a balance between therapeutic potential and public safety, ensuring that any future regulatory changes are grounded in science.

A Paradigm Shift: FDA and Mono-Molecule Psychedelics

Contrasting its cautious approach to cannabis, the FDA has taken significant strides in recognizing the potential therapeutic benefits of mono-molecule psychedelics. Emerging research demonstrates the efficacy of substances like psilocybin, MDMA, 5-MeO-DMT, and ketamine in treating mental health disorders. To facilitate further research, the FDA has granted certain psychedelic-assisted therapies the prestigious "Breakthrough Therapy" designation. This designation expedites the approval process, offering a clear pathway for the development of these innovative treatments. That's drawing a lot of interest from people who see a future where psychedelics might revolutionize mental health care.

Safety Considerations & Public Opinion: Cannabis vs. Psychedelics

Safety's always a big deal, no matter the substance. Cannabis use has its risks, like affecting how we think and drive. They're still researching the long-term effects. But the FDA seems to believe the mono-molecule psychedelics have a better safety profile when used responsibly and under supervision. The public seems to share that perception. Psychedelics have been gradually shedding their countercultural image, supported by mounting evidence of their therapeutic potential, while cannabis is still seen as a recreational drug, sometimes used without much control. While medical cannabis is gaining acceptance, recreational use continues to face social stigma. As we know, public perception plays a pivotal role in shaping regulatory decisions so that should also accelerate regulation of psychedelics.


While we watch the slow burn on the cannabis side, eagerly awaiting the next news from the FDA on cannabis by the end of year, the FDA's recent guidance on psychedelics is a spark for psychedelic medicine. Research is unfolding, and we're learning more about the potential of both cannabis and psychedelics. The way the FDA deals with these mono-molecule psychedelics might pave an easier path for their regulation, and we hope it also provides momentum on the cannabis side as social acceptance and trust continue to grow.

Here at Frontier Risk, we're right in the thick of things, and we’ve got your back if you’re in the cannabis or psychedelics biz. We know you're taking big risks, and we'll help you get the right insurance to keep your business safe and sound. As we look to the future of cannabis and psychedelics, we'll be here, supporting you and the whole industry in this ever-changing regulatory landscape.

Courtney Stough
Chief Legal Officer & COO
Chief Operating Officer, Chief Legal Officer & Secretary at Frontier Risk with an extensive experience in corporate governance, capital-raising, and a variety of transactional matters.

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