Decriminalization vs. Legalization vs. Regulation: What's the Difference?

One can be forgiven for struggling to keep up with the legal status of different drugs and medicinal compounds in the United States. Knowing what drugs fall under what classification these days, depending where you are in the country can be tricky to navigate.

Cannabis, for example, has come a long way since it was subjected to the “Reefer Madness” treatment of the 1930s. Once a vilified and criminalized substance, marijuana is now legal, either medically or recreationally, in a majority of states in the U.S. That monumental shift is currently underway for certain psychedelic drugs, like psilocybin (mushrooms) and MDMA, which are proving to have promising results when treating the effects of certain mental health conditions, along with already legal ketamine.

Mark Haden is an adjunct professor at the University of British Columbia and Director of Clinical Health at Psydin, a psychedelics and clinical trials company. He spoke to Mindbloom about the differences between decriminalization, legalization and regulation when it comes to the statuses of psychedelic medicines across local, state, and federal jurisdictions in the U.S.

Decriminalization

When a substance is decriminalized, it means that the substance is not criminalized and there are no criminal penalties for drug law violations. But Haden explains that there’s degrees of decriminalization, which could apply to the amount of possession before the law kicks in, as well as severity of punishment.

“With decriminalization, there might not be a criminal penalty, but civic ones, like a fine, could still apply,” he says. “Decriminalization is a scale, really, of the amount of civil and legal sanctions that apply to possession or sale of a substance.”

In February, Oregon became the first U.S. state to decriminalize possession of small amounts of “hard” drugs, a decision that was made by ballot measure. That means anyone in the state caught with small amounts of psilocybin, LSD, MDMA, heroin, methamphetamine or other drugs can no longer be arrested by police. They can, however, still face a civil citation, the equivalent to a traffic ticket.

In 2019, Denver, Colorado, became the first city in the U.S. to decriminalize hallucinogenic mushrooms, in an effort to cut back on city spending. The purpose and intent of the Denver Psilocybin Mushroom Initiative was to deprioritize “spending resources on imposing criminal penalties” for the personal use and personal possession of psilocybin mushrooms.

Legalization

Legalization sits within the context of federal or state regulatory structure. In contrast, within the decriminalization structure, access to the substance is generally through illegal markets.

With legalization, the substance becomes a regulated legal product and access comes from legal markets. However, the way legalization works varies widely.

Oregon is the only state where psilocybin mushrooms are both decriminalized and legal, the latter of which is only designated for use in controlled therapeutic settings.

You won’t be able to buy them in a corner store or grow them at home, since it’s the legalization of a service, rather than the legalization of the product. The only legal means of accessing psilocybin mushrooms in the state of Oregon is through a licensed professional. It is currently in a two-year development plan to hammer out the rules and regulations for the first-ever psilocybin therapy program in the country.

And while the legalization and decriminalization of psilocybin is recognized in the state of Oregon, federally, the substance is still considered a Schedule I substance under the Controlled Substances Act.

“There's a variety of legal portholes that are opened up through the process of legalization so it’s brought within the context of government in terms of how it’s accessed,” explains Haden. “Which government arm makes it available varies based on country and state.”

Regulation

When a drug is legalized, an important part of the process is determining how it will be regulated. Rules and directives are established largely by government agencies that outline how a substance will be legalized, distributed, and/or administered.

For example the U.S.’ Food and Drug Administration (FDA) determines which substances are available for on-label medicinal use — the use it’s specifically approved for. But Haden explains the word “regulation” is broader than that for institutions like Canada’s College of Physicians and Surgeons, and the professions that make it available, such as licensed clinicians.

“In the [Canadian] context of psychedelics, if there’s a regulated body, discipline, or profession that makes these things available, the profession that makes them available, like the psychedelic supervisors, the psychedelic guides, and the psychedelic therapists report to their College for oversight and training, and that’s also regulation,” he says.

Ketamine, for example, is a drug that is currently legal to be prescribed for multiple on and off-label uses. While its initial FDA-approved application being as an anesthetic, it’s also used off-label for pain management and mental health treatment.

Ketamine has been observed to be useful at a lower dosage for depression and other mental health conditions. Its use in those contexts, such as major depressive disorder (MDD), post-traumatic stress disorder (PTSD), and suicidal ideation, has only gone through Phase 1 and 2 clinical trials in the FDA approval process to prove its effectiveness, so it’s currently used off-label.

Only esketamine, a low dose ketamine nasal spray that’s sold under the brand name Spravato, is available in the US as an on-label prescription specifically for treatment resistant depression, as it has passed Phase 3 clinical trials and FDA approval.

Eskatmine is the s-isomer of racemic ketamine. Racemic ketamine has both the r-isomer & s-isomer. Isomers mean they have the same chemical compound and makeup but are arranged differently. While ketamine’s use in all situations hasn’t been approved by the FDA, it’s still able to be used off-label given its legal status.

Another compound that’s currently in the midst of being regulated for legalization in the U.S. is MDMA —also known as “ecstacy” or “molly.” The drug has been found to have a positive effect for those with PTSD, when used along with talk therapy. Phase 3 clinical trials are complete, with recently published data set to be reviewed by the Federal Drug Administration. Its approval for therapeutic use could come as early as 2023.