The DEA published a new document in the Federal Register on September 2 requesting an increase in production for certain Schedule I and Schedule II substances so that it can initiate more research studies.
Titled “Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2021,” the article specifically includes some major changes for cannabis and psilocybin.
In the document’s section dedicated to explaining adjustments for 2021, it begins with mentioning the changes to cannabis and psilocybin. “DEA is proposing significant increases to the APQs of the schedule I substances psilocybin, psilocin, marihuana, and marihuana extract, which are directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes,” the DEA writes.
“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.”
Among many scheduled substances listed in a chart, no changes were noted between the “established 2021 quotas” and “proposed revised 2021 quotas.” For the entries that did include a change, most were increased by only 30 grams, with a few exceptions. However, the listing for psilocybin received a proposed increase from 30 grams to 1,500 grams, and psilocyn received an increase from 50 grams to 1,000 grams. Likewise, “marihuana” received a bump from 1,500,000 grams to 2,000,000 grams, and the “marihuana extract” quota increased from 200,000 grams to 500,000 grams.
The DEA does not go into detail regarding why it is suddenly so interested in studying psilocybin and psilocyn in large quantities, but the substance has received a good amount of attention over the past year. The state of Oregon will soon be voting on psilocybin legalization initiative called IP-34 this November. California residents will be voting on the California Psilocybin Decriminalization Initiative 2022 in November as well.
Canada is embracing psilocybin as medicine for four terminally ill patients. Many new studies are exploring the medical properties of the substance, and finding that it’s helpful in treating conditions like depression. Some states in the U.S. have lessened penalties for possession of psilocybin, and others have fully embraced it, such as Ann Arbor, Michigan making September “Entheogenic and Fungi Awareness Month.”
For cannabis, the ongoing restriction as a Schedule I substance will eventually come to an end. A petition led by Dr. Sue Sisley, whose work on medical cannabis to treat conditions such as PTSD, sought to force the DEA to reschedule cannabis. While the case in the United States Court of Appeals for the Ninth Circuit was dismissed on August 30, 2021, Circuit Judge Paul Watford wrote a statement as a part of his ruling that cannabis reclassification could be a possibility in the future.
“I agree that the petitioners in this case failed to exhaust their administrative remedies and therefore join the court’s opinion dismissing their petition for review,” Watford wrote. “I write separately to note that, in an appropriate case, the Drug Enforcement Administration may well be obliged to initiate a reclassification proceeding for marijuana, given the strength of petitioners’ arguments that the agency has misinterpreted the controlling statute by concluding that marijuana ‘has no currently accepted medical use in treatment in the United States.’”
Comments for the DEA’s most recent article can be submitted between now and October 4.