Understanding the Regulatory Environment Around Psychedelics

Oregon’s trailblazing legalization of the use of psilocybin in 2020 sparked nationwide interest, hinting that public and political taboo around these psychedelic substances could finally be lifted.?

How did we get here? Here’s everything you need to know about the regulatory environment around psychedelics:

State of current regulations

“Psychedelic” is a broad term that includes mushrooms, LSD, MDMA, and ketamine. Regulations differ depending on the type of substance, with certain ones allowed more legal leeway than others.

Ketamine, for example, has been an FDA-approved anesthetic since 1970. This dissociative drug is currently listed as a “Schedule III” compound under DEA guidelines, which means that it is recognized to have medical value for specific purposes, such as treating mental health issues. Licensed providers and registered practitioners can legally use ketamine in assisted therapy to help patients suffering from depression and PTSD. In addition to off-label ketamine prescriptions, the FDA recently approved derivatives such as esketamine for treatments of adults with treatment-resistant depression.

MDMA is another substance that has a good chance of becoming more accepted. In 2017, the FDA designated MDMA-assisted psychotherapy as a breakthrough therapy. This designation is intended to “expedite the development and review of drugs for serious or life-threatening conditions.” Expanded access status for MDMA was granted in 2020.

Other types of psychedelics such as mushrooms, LSD, and DMT are still considered “Schedule 1 substances” by the federal government and are therefore “illegal to produce, sell, possess, or consume without special government authorization.” While most states still forbid the use of psychedelics, even for therapeutic purposes, there are exceptions in certain localities:

Oregon became the first state to legalize the use of mushrooms and psilocybin. Colorado, California, Massachusetts, and Michigan partially decriminalized these substances, which are now legal in specific cities.

Why do these regulations exist?

There are several obstacles to the legalization of psychoactive substances, whether legal or political. Strict regulations first stem from the decade-long scientific aversion to psychedelic research, which began in the 1970s. This aversion accompanied a strong negative public opinion on psychedelics, reinforced by the media painting these substances as dangerous drugs that could induce “bad trips” and destroy a person’s life.

For many years, psychedelics were considered taboo, and the promising studies and interest of the early ‘60s were suddenly halted. Deep stigmas still linger, with these “party” drugs widely seen as dangerous and harmful. Thanks to the recent psychedelic revival we’ve seen a new wave of interest and research.?

What’s coming up?

Since 2016, the discussions around psychedelics have become more open, and there have been promising steps toward understanding these substances.?

• On Jan. 5, 2022, Washington State legislators proposed “Senate Bill 5660,” which would legalize psilocybin for “supported use” among adults 21 and older.?
• In Sept. 2021, California State Sen. Scott Wiener introduced “Bill 519” to decriminalize personal possession of small amounts of psychedelic substances in the state. This bill is set to be discussed this year.?
• MDMA’s breakthrough therapy status could lead to FDA approval by 2023, leading the way for other treatment drugs.

What could the future look like?

In the future, psychedelics could follow the footsteps of cannabis legalization, which has been gaining support at the federal level. With this new revival, we can already see that public opinion is slowly but surely changing: psychedelics are becoming more destigmatized and there seems to be a real discussion about their therapeutic benefits. As scientific research and mental health awareness become more prominent, these psychoactive substances could also become politically embraced.