PSILOCYBIN
Psilocybin, the primary psychoactive ingredient in many varieties of mushrooms (also known as magic mushrooms, or shrooms), is considered to be the most well-known naturally occurring psychedelic substance. Despite being scheduled by the federal government as a Schedule I controlled substance, psilocybin is currently being studied clinically and may become a psychiatric medication in the next few years, making it the most notable since Prozac according to The New York Times.
As the acceptance of psychedelic therapies have gained a traction across the medical community, our firm is once again at the forefront in representing clients in this growing area of treatment. Similar to the emerging days of the medical cannabis movement, psychedelic drugs such as MDMA, psilocybin, LSD, ketamine and DMT are being used in new ways while still operating in a complex legal and regulatory environment. The Firm guides researchers, manufacturers, investors, clinicians and other participants around and through the myriad obstacles that result from the patchwork of state and federal laws regulating Schedule I controlled substances. We assist entrepreneurs in forming ventures and developing structures best suited for operation in the psychedelic industry. Once established, clients turn to our regulatory and finance lawyers to assist with operationalizing and funding the enterprise. Our clients benefit from our attorneys’ comprehensive experience in compliance with current good manufacturing practice (cGMP) requirements applicable to cannabis and hemp products and their application to best practices in psychedelic therapies.
History of the psilocybin industry in the US
Psilocybin has been used for thousands of years already by indigenous peoples throughout the world. Westerners, on the other hand, didn’t start ingesting magic mushrooms until the late 1950s. Thanks to R. Gordon Wasson’s 1957 LIFE Magazine picture story on his religious experience in Mexico, psilocybin experienced a re-popularization.
Wasson submitted a sample to Albert Hofmann, the Swiss chemist who had discovered LSD. His group at Sandoz Pharmaceuticals started making 2 mg tablets for research purposes after Hofmann isolated psilocybin. Thousands of psilocybin dosages were given in clinical trials during the next two decades.
Despite its extensive history and current therapeutic and medical study, authorities believed psilocybin was being misused and wanted to suppress the counterculture it facilitated. The US had deemed ‘magic mushrooms’ illegal by 1968, and they were listed as a Schedule I narcotic under the Controlled Substances Act in 1970.
Psilocybin began to be liberalized when the Food and Drug Administration gave psilocybin Breakthrough Therapy Designation for research purposes in October 2018. This designation enables researchers to accelerate the development of medications that have early promise in treating certain illnesses. States have also liberalized laws against psilocybin. In May 2019, Denver, Colorado became the first city to decriminalize psilocybin. In June 2019 and January 2020, Oakland and Santa Cruz, California, decriminalized the drug. Washington DC followed in November 2020, then Somerville, Massachusetts in January 2021, and Cambridge, Massachusetts in February 2021.
Psilocybin’s medicinal benefits are being researched in more depth. As controlled substance policies liberalize for study and medical/recreational use, a promising development is the legalization of psilocybin. As of late, the nation’s leading institutions are rushing to open psychedelic research centers, and investors are flooding millions into the market.
Is psilocybin legal in the United States?
To address the question, the most basic response is no. In accordance with the Controlled Substances Act, psilocybin is still considered a Schedule I prohibited substance, making it unlawful to cultivate or possess psilocybin-producing mushrooms for either personal use or distribution. In the United States, there are no places where psilocybin is legal to purchase or use for recreational reasons in any form. A license from the Drug Enforcement Administration (DEA), on the other hand, allows them to be used for scientific research under highly controlled conditions.
While there is still a long way to go before psilocybin is completely decriminalized throughout the country, interest in the substance is growing at a quick pace and activists in certain jurisdictions are pressing for broader decriminalization.
In November 2020, voters passed Oregon Ballot Measure 109, making Oregon the first state to decriminalize psilocybin. Measure 109 will allow for the legal access of psilocybin for the treatment of mental illnesses in supervised conditions.
The legality of psilocybin is still rather limited. While the use and possession of psilocybin have been decriminalized in Oregon and portions of Colorado, California, the District of Columbia, and Massachusetts, federal law prohibits the use, sale, and possession of the compound throughout the United States.
Psilocybin Opportunities: The DEA is increasing the amount of psilocybin that can be legally produced
The usage of schedule I substances for research and clinical trials has increased significantly, and the DEA is showing its support as indicated by the quota increase for 2022 in comparison to previous years. The DEA establishes an Aggregate Production Quota limiting the amount of psilocybin that can be produced lawfully. To give you an idea of how much has been or will be allowed over the years:
- 2019: 30g established quota
- 2020: 30g established quota
- 2021: 30g established quota, 1500g proposed revised quota
- 2022: 3000g proposed quota
Initially, the Aggregate Production Quota (APQ) for psilocybin that could be legally produced in 2021 was set at 50 grams in November 2020. However, on September 2nd, 2021, the DEA stated plans to dramatically increase psilocybin production in 2021, which is linked to a rise in DEA registrants’ interest in using schedule I substances for research and therapeutic trials. The APQ for research-grade psilocybin has been increased to 1,500 grams, representing a 2,900 percent increase over the previous 50-gram limit.
While the DEA has already increased its proposed psilocybin quota for 2021, it is now seeking a wider range of psychedelics to be manufactured and wants to further increase the quantity of psilocybin from 1,500 to 3,000 grams in the following year, 2022.
The APQ increase reflects the necessity to complete research and development requirements for new drug products prior to FDA clearance. The increase in the quota also implies a progressive view of the substance’s medical potential as more jurisdictions continue to modify their restrictions around it.
Psilocybin Research
Psilocybin levels in these mushrooms are typically between 0.2 and 0.4 percent. Psilocybin is deemed active at doses of 3-4 mg, however, the most typical dose utilized in clinical research settings is between 14 and 30 mg.
If you plan to study schedule I controlled substances like psilocybin, you must:
- IRB Clearance – First, obtain Institutional Review Board (IRB) clearance. That’s where you show the public the advantages of psilocybin research.
- DEA Approval – Following IRB clearance, you need Drug Enforcement Agency (DEA) permission. You need to fill out a ton of paperwork on how and why you want to research psilocybin, how much you’ll have, and how to store it properly, among other things. For more information on the DEA registration procedure, you may call 1-800-882-9539 or contact the Local Diversion Field Office.
- NIDA Approval – You will also apply to the National Institute of Drug Abuse (NIDA) for the actual drugs. This process will take several years and conclude with a site inspection by a federal law enforcement agency.
As further studies into psilocybin’s medical advantages are carried out, the legal position of this substance may progressively change in the United States. The approval of research use of psilocybin is a rigorous process. Moriconi Flowers has successfully assisted clients in approvals with the DEA and other government organizations.