The Drug Enforcement Administration (DEA) is proposing a massive increase in the production quotas of cannabis, psilocin, and psilocybin (“magic mushrooms”) for research purposes, with the intent of aiding in the development of new federally approved therapeutic medications. The proposal highlights the growing acceptance that Schedule I substances like marijuana and psilocybin may hold great medical promise as therapeutics.

What Is Psilocybin?

Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi. Psilocybin and other psychedelics are on Schedule 1 of the federal Controlled Substances Act (CSA), just like cannabis. The designation is given to substances having “no currently accepted medical use and a high potential for abuse.”

Nonetheless, studies have shown that psilocybin has the potential to treat a variety of psychiatric and behavioral disorders, including depression, obsessive-compulsive disorder, smoking cessation, alcohol and drug addiction, cluster headaches, and cancer-related or other end-of-life psychological distress. Cancer-related psilocybin therapy is widely regarded as the most promising areas of research for the drug.

Given its potential benefits, efforts are underway to decriminalize the drug and make it easier to pursue further medical research. Decriminalization of psychedelics via local/municipal legislation is already gaining momentum.  Notably, New Jersey Gov. Phil Murphy signed legislation in February reducing penalties for possession of up to an ounce of psilocybin mushrooms by reclassifying the infraction to a disorderly person's offense.

DEA Proposed Adjustments to Aggregate Production Quotas

Section 306 of the CSA requires the Attorney General to establish aggregate production quotas (APQs) for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of DEA.

The DEA’s recent proposal calls for significant increases to the APQs of the schedule I substances psilocybin, psilocin, marihuana, and marihuana extract. According to the DEA, the proposed increases are “directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes.” The proposal further states: “DEA firmly believes in supporting regulated research of schedule I controlled substances. Therefore, the APQ increases reflect the need to fulfill research and development requirements in the production of new drug products, and the study of marijuana effects in particular, as necessary steps toward potential Food and Drug Administration (FDA) approval of new drug products.”

While the DEA regularly adjusts APQs, the language used by the DEA is notable, as it expressly highlights the prospect of new drug products using the substances. The extent of the increases is also significant. The DEA is proposing to increase production of marijuana to 2 million grams (approximately 4,400 pounds), which represents a 500,000-gram increase from its initial APQ for 2021. The DEA is also seeking to manufacture 500,000 grams of cannabis extract, which is more than twice its original APQ. With regard to psilocybin and psilocin, production will also expand significantly under the DEA proposal. The APQ for psilocybin would increase to 1,500 grams, which is a 2,900 percent increase. The DEA is proposing to produce 1,000 grams of psilocin, up from its initial 2021 proposal of 50 grams.

What’s Next?

The DEA proposal was published in the Federal Register on September 2, 2021, and interested parties had 30 days to submit comments. Based on comments received in response to the proposal, the DEA Administrator may hold a public hearing on one or more issues raised.

While cannabis legalization continues to dominate headlines, psychedelics have the potential to be cannabis 2.0 – not because of their recreational use, but for their increasingly confirmed efficacy in medical treatment of mental health issues like PTSD, depression, anxiety (including end-of-life anxiety), and addiction, which may result in inevitable legalization. Scarinci Hollenbeck’s Cannabis Law Group is closely monitoring this rapidly evolving area of law.

If you have questions, please contact us

If you have any questions or if you would like to discuss the matter further, please contact Dan McKillop or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.