Denver Decriminalizes Psilocybin

On Wednesday, May 8, 2019, Denver, Colorado announced a pass result for Initiated Ordinance 301, becoming the first U.S. jurisdiction to decriminalize psilocybin-containing mushrooms. The ballot title reads as follows:

Shall the voters of the City and County of Denver adopt an ordinance to the Denver Revised Municipal Code that would make the personal use and personal possession of psilocybin mushrooms by persons twenty-one (21) years of age and older the city’s lowest law-enforcement priority, prohibit the city from spending resources to impose criminal penalties for the personal use and personal possession of psilocybin mushrooms by persons twenty-one (21) years of age and older, and establish the psilocybin mushroom policy review panel to assess and report on the effects of the ordinance?

Again, this is the first time a U.S. jurisdiction has actually approved of the decriminalization of psilocybin, and this could have major effects throughout the nation. Let’s break down exactly what this law does and doesn’t do.

psilocybin denver legalFirst, the law doesn’t “legalize” psilocybin to the same extent that cannabis has been “legalized” in many states. Decriminalization is a very different concept. The law will effectively make it the lowest possible enforcement priority and prohibit the expenditure of resources to arrest adults ages 21+ from consuming or possessing psilocybin mushrooms only. For now, manufacturing psilocybin-containing products or selling them remains completely illegal—and so does consumption in public places.

Second, the law obviously changes nothing about the Controlled Substances Act or state law. Psilocybin is still a Schedule I substance per the federal Controlled Substances Act and Colorado law. Theoretically, nothing’s stopping the feds or state police in Colorado from arresting users or possessors of psilocybin, and only time will tell how that will play out.

Third, the law only decriminalizes psilocybin-containing mushrooms, defined as “fungal matter containing psilocybin, psilocin, baeocystin, or nor-baeocystin.” The law does not expressly allow for the manufacture of food or other products out of mushrooms.

Fourth, the fact that this is only a decriminalization measure means that it won’t move the needle forward on creating a market for these products. Decriminalization just will protect some users from facing jail time. In order to establish a lawful market for psilocybin products, a jurisdiction would need to “legalize” it (like with cannabis) and create regulations for the harvesting, production, sale, labeling, testing, advertising, and marketing of psilocybin. That probably won’t happen in the near future, but decriminalization is a step in that direction.

Moreover, though Denver was the first place to decriminalize, it’s not the only effort underway to expand access to psilocybin. We wrote previously about an Oregon measure to decriminalize psilocybin and other states may similarly follow suit (apparently, activists have already started trying to organize a ballot initiative in California).

One big potential snag for psilocybin activists is the  FDA-approved drug trial for psilocybin that we wrote about previously. If we’ve learned anything from the FDA’s cannabidiol (“CBD”) policy, it’s that the FDA’s approval of Epidiolex (a CBD containing drug) has caused the FDA to largely take a contra-CBD position:

…If a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.

In other words, if the FDA ever approves of a drug containing psilocybin, then that may serve as a bar to future non-FDA approved sales, similarly to what we are now seeing with CBD.

Again, the world of potentially lawful psychedelics is very new and the next few years are likely to see major updates. Even though this is the Canna Law Blog, we’ll continue to provide updates on the state of psilocybin law as it evolves.

Read More

Colorado, FDA, Legal Issues