A Framework for Regulating the Promotion of Psychedelics in a Fully Legalized Context

As many readers of this Bulletin will know, psychedelics are increasingly entering mainstream consciousness because of their documented positive effects. As most readers will also know, to date, most public education and communication around psychedelics have been focused on prohibition and abstinence. Given this uptick in interest and the historic state of psychedelics education and communication, there is a need for new policy around psychedelic promotion and education to help users maximize potential benefits and minimize potential risks, especially outside of a therapeutic context. Policy research on psychedelics use and regulation has been limited, given these are controlled substances and research focuses mostly on the medical model. 

In the academic year 2022/23, I conducted research on psychedelic policy in partial fulfillment of the requirements for my degree of Master in Public Policy at the Harvard Kennedy sSchool. The research was as a policy analysis exercise with MAPS as my client and the full report is available at the Harvard Library. It addressed the following problem statement: In a fully legalized setting, how should a government entity regulate the promotion of psychedelics by private sector actors to minimize risk and maximize potential benefits for consumers? This project focused on psychedelic promotion for the general public. Its goal was not advocacy for full legalization of psychedelics. Rather, it attempted to look down the road and provide analysis that could inform regulatory policies in the case of a full legalization scenario. 

My research methodology involved qualitative findings, based on interviews with psychedelic experts and other drug experts, as well as a review of psychedelic products sold legally in Canada and the Netherlands, cannabis products, ketamine services, dietary supplements, and a proposed FDA framework for over-the-counter versions of prescription drugs. Noting that these substances are markedly different from psychedelics in their effects and outcomes, the aim of this exercise was to help provide examples on how different products are regulated, and a spectrum of different approaches that could be suitable for psychedelic promotion regulation. 

Most individuals interviewed for this project believe that psychedelic advertising and branding should be heavily regulated, unlike current regulations in the United States on the promotion of substances such as alcohol, tobacco, dietary supplements, cannabis, and ketamine. A concern shared by most interviewees is the inherent tension between the same companies profiting from psychedelics and then educating people about their use. One potential pushback recognized by interviewees is that the potential safety of psychedelics may provide space for less strict regulation on promotion, but these interviewees emphasized that public education is a much more effective tool for maximizing benefits and minimizing risks than promotion by private sector actors. While all interviewees recommended substantive regulation on psychedelic promotion, recommendations ranged from a complete ban on branding and advertising to certain controls on what to advertise, who to advertise to, and how to brand. 

As there has been interest in how state-level cannabis legalization can inform psychedelic policy, I will highlight some of my specific findings on cannabis in this article. One interviewee for this project highlighted that cannabis companies “are making all sorts of claims based on fuzzy science,” catering to people’s growing interest in wellness and self-help by offering products that they claim can help with increased sleep or libido, decreased anxiety, and more. This interviewee and others provided some best practices for regulating the promotion of psychedelics based on experiences with cannabis, which were: 

  • A public health-informed process that determines what the most important claims and risks to be shared with potential users are, similar to the process in Canada that ensured potential mental health effects or risks to pregnant women were included on product labels. 
  • A system where key education and its delivery is coming from a source that is not motivated by profits, such as an independent standard setting organization funded by the industry or a quasi-governmental organization. 
  • Regulation that is not based on a consumers’ packaged goods precedence. For example, banning the type of lifestyle branding currently employed by cannabis companies in the U.S., which one expert felt was “determinantal to public health and meaningful education.” Experts referenced examples from Canada and the Netherlands, where branding, advertising, and even the use of cannabis symbolism is very limited. 

Capturing these opinions and insights from the regulation of other substances, I developed a list of design principles that regulators could consider and then assessed the different examples considered in this project against them:

  • “Just say know”: A more informed psychedelic “culture” is required so that the public can develop critical thinking skills about promotional material they may see. Given the harm reduction point of view, the potential safety of psychedelics, and the thousands of years of their usage in many cultures, “even-handed” information on both their potential benefits and risks are needed so that potential users can make informed choices. 
  • “Designing situated policy”: As one expert mentioned, providing corrective information requires an understanding of where people are, especially given the wide range of narratives the population holds when it comes to psychedelics. There is much misinformation on psychedelics, including on dosage, potential harmful effects, potential beneficial effects, and more. Both this misinformation and who a regulator is regulating for needs to be understood prior to designing specific policies on promotion.
  • “Cultivating respect”: Psychedelics have a history of thousands of years of use in spiritual practices among Indigenous cultures. They also have a history of being condemned in the West for decades. Now that psychedelics are beginning to reenter the legal framework (e.g. psilocybin and Oregon), cultivating respect among potential users and regulators can help design more thoughtful policy.
  • “Breaking the allure”: Psychedelics are used therapeutically and socially, however, they are not panaceas or silver bullets and contain potential risks in any setting. Policy can focus on “breaking the allure” through designing regulations that restrict private sector actors from glorifying these substances, while also ensuring regulation does not villainize them.
  • “Emphasizing set and setting”: Any individual experience is a result of drug, set, and setting. Thus, any claims made on product packaging or in product advertising taken from clinical trials results can be misleading. Regulators can ensure that potential users understand the variability of experiences based on external and internal factors as well as methods of ensuring more effective set and setting (e.g., having a trusted companion or professionally trained guide around for the experience). 
  • “Protecting those who have a lot to gain and lose”: Regulators must consider the variability of each individual experience in evaluating claims or in considering whether to permit certain advertising techniques (e.g., targeted advertising, patient testimonials).
  • “Incentivizing science”: Similarly to cannabis, there will be a risk with psychedelics that the science is behind the marketing claims. However, in contrast to cannabis, psychedelic science is already rich with data from clinical trials. This may provide a challenge in the context of full legalization, as a clinical trial is a controlled environment with a specific set and setting. More research will be needed on the use of these substances outside of these controlled environments, which regulators can work to incentivize. 

I then provided recommendations on what an “ideal” advertising regulatory framework would look like, and discussed how the general risks of private sector advertising of psychedelics in a fully legalized context could be mitigated by regulators – mainly through comprehensive public education and public investment into psychedelic research. In the conclusion of my report, I considered that policymakers may choose other less “ideal” regulatory frameworks, such as a model based on cannabis promotion in some places within the U.S. I then provided ideas on how the risks of these models may be mitigated. A key message I hope to convey from this framing is that there are political, economic, and cultural forces that will shape psychedelics policy, sometimes in contrast to expert consensus. If regulators are to make these choices, I believe they must understand why they are making them, take their risks seriously, and develop mitigation strategies.

Dana Karout is an Adaptive Leadership Teaching Fellow at the Harvard Kennedy School (HKS). She graduated with a Master in Public Policy from HKS in May 2022, where she completed her capstone project on psychedelic policy. She has worked with dozens of leaders on complex challenges in government and other sectors. Her work draws on psychology, philosophy, and contemplative modalities to create possibilities for individual and systemic transformation.