The regulation of psychedelic substances in the United States

The Controlled Substances Act (21 U.S.C. 13) prohibits the manufacture, importation, possession, use, and distribution of psychedelic substances as Schedule I substances with ‘no currently accepted medical use.’

Some exceptions are made for religious ceremonies, such as under the Religious Freedom Restoration Act of 1993 and the American Indian Religious Freedom Act Amendments of 1994.

In 2017, the US Federal Drugs Administration (FDA) designated two psychedelics, psilocybin and MDMA, as ‘breakthrough therapies’ which permits the study of psilocybin for depression and MDMA for PTSD in clinical trials. It is anticipated that the FDA will be asked to approve MDMA and psilocybin by mid-2024.

Efforts to remove regulatory barriers that inhibit the use of psychedelics in research and compassionate use cases, such as Senators Cory Booker and Rand Paul’s Breakthrough Therapies Act (S.689) (pending) and Rep. Dan Crenshaw’s Douglas ‘Mike’ Day Psychedelic Therapy to Save Lives Act of 2023 (H.R.3684) (pending), have yet to be passed.

On 22 June 2023, the powerful US Senate Committee on Appropriations encouraged the Department of Veterans Affairs ‘to explore opportunities to assist with privately-funded research programs to evaluate the efficacy of psychedelic therapies in treating PTSD, major depressive disorder, and other serious mental health conditions.’

On 23 June 2023, the FDA released its first draft guidance on clinical trials involving psychedelic drugs. It outlines considerations relating to trial conduct, data collection and subject safety.

House Bill 2489 (enacted): This Act allows for the prescription of MDMA for the treatment of PTSD when it is both FDA-approved and rescheduled by the US Drug Enforcement Administration. It was signed into law by Arizona Governor Katie Hobbs on 28 April 2023. 

House Bill 2486 (pending): Introduced on 19 January 2023, this bill would provide funding for psilocybin research and create a five-person psilocybin research advisory council within the Arizona Health Services Department, which would outline clinical trial criteria and oversee a grant application process. The bill was approved by the House Military Affairs and Public Safety Committee unanimously on 13 February 2023. The bill as yet to be enacted.

Between 2019 and 2023, the cities of Oakland, Santa Cruz, Arcata, and San Francisco have ‘decriminalised’ entheogens (natural psychedelic substances) such as psilocybin by deprioritising the enforcement.  

Senate Bill 58 (pending): This bill would legalise, among other things, the possession of natural psychedelics such as psilocybin, psilocyn, DMT, ibogaine, and mescaline. The bill was passed by the California Senate on 24 May 2023. It was then sent to the California Assembly for consideration and was referred to the Assembly’s Committees on Public Safety and Health on 1 June 2023. On 28 June 2023, the Public Safety Committee approved the legislation with amendments. As of 29 Jun 2023, the bill has yet to be passed the Assembly.

In May 2019, Denver, Colorado became the first city to ‘decriminalise’ psilocybin.

On 8 November 2022, voters approved Proposition 122 that sought to ‘decriminalise’ psychedelic plants and fungi. This led to the signing of Senate Bill 23-290 (enacted) on 23 May 2023. Under the Act, adults may possess and use psilocybin. It also proposes the eventual ‘decriminalisation of the substances DMT, ibogaine and mescaline (excluding peyote). The law creates a framework for regulated centres for the provision of medically supervised psilocybin treatment.

House Bill 5506 (enacted): This Act was signed by the Governor Ned Lamont on 7 May 2022 and specifically earmarked funds for a psychedelic-assisted therapy pilot program. Under the pilot program, veterans, retired first responders, and direct care health care worker could be qualified to receive MDMA-assisted or psilocybin-assisted therapy at an FDA approved treatment site. A Connecticut Psychedelic Treatment Advisory Board would advise the Department of Mental Health and Addiction Services ‘on the design and development of the regulations and infrastructure necessary to safely allow for therapeutic access to psychedelic-assisted therapy upon the legalization of MDMA, psilocybin and any other psychedelic compounds.’

Substituted House Bill 6734 (pending): This bill would ‘decriminalise’ possession of small amounts of psilocybin, punishing the first offense with a $150 civil penalty and subsequent offenses with $200-$500 penalties. It was introduced by the Judiciary Committee on 17 April 2023. The House passed the bill on 10 May 2023, and it has now been sent to the Senate for consideration.

House Bill  6146 (pending): This bill would implement a psychedelic assisted therapy pilot program by appropriating money from the General Fund. It was referred to the Joint Committee on Public Health on 18 January 2023. On 8 February 2023, the bill was referred to the Appropriations Committee. 

House Bill 5102 (pending): This bill would allow the use of psilocybin for medicinal and therapeutic purposes. It was introduced on 9 January 2023. The bill has been referred to the Joint Committee on Public Health.

Entheogenic Plant and Fungus Policy Act of 2020 (enacted): This Act ‘decriminalised’ natural psychedelics such as psilocybin, ayahuasca, and mescaline, by deprioritising prosecution to the lowest level. The Act came into effect on 15 March 2021 following the passing of Initiative Measure No. 81 in November 2020.

Senate Bill 1454 (pending): This bill would create a state research taskforce for psilocybin. The bill was passed by the Senate on 11 April 2023 and has been sent to the state’s House for consideration.

Senate Bill 1531 (pending): This bill would create a Beneficial Treatments Advisory Council studying therapies with psilocybin and MDMA. The bill was passed by the Senate on 11 April 2023 and has been sent to the state’s House for consideration.

House Bill 1340 HD2 SD2 (pending): This bill would create an advisory council within 3 months of breakthrough therapy designation approvals for psilocybin and MDMA by the FDA. It was approved by the Senate with amendments on 11 April 2023. On 13 April 2023, the House disagreed with the Senate’s amendments and the bill has been sent to Conference.

House Bill 0001 (pending): This bill would create a state-regulated psychedelic-assisted therapy program for adults. It was first read on 12 January 2023 and referred to the Rules committee on 10 March 2023.

Senate Bill 2353 (pending): This bill would authorise the distribution and public availability of psilocybin for medical, psychological and scientific studies and research through an amendment to the state’s drug code. The bill received its first reading on 10 February 2023 and was referred to the Assignments Committee on 10 March  2023.

House File 240 (pending): This bill would remove psilocybin and psilocyn from the state’s list of controlled substances. It was referred to the Public Safety Committee on 8 February 2023 and received a recommendation from that Committee for passage on 11 April 2023.  

On 31 May 2023, Kentucky Attorney-General Daniel Cameron announced that the state would take $42 million from its portion of the Opioid Settlement Fund and invest it into researching addiction treatment with ibogaine.

Legislative Document 1914 (pending): This bill was introduced into the Maine Senate on 9 May 2023, to enact the Maine Psilocybin Health Access Act. This bill would follow a model similar to Oregon and allow for the administration of psilocybin from licensed manufacturers, at licensed centres under the supervision of licensed psilocybin facilitators. The act would also ‘decriminalise’ the personal possession, growing, and use of small amounts of psilocybin by persons 21 and older. The bill was tabled by the Committee on Veterans and Legal Affairs on 22 May 2023 and a carryover request was made on 1 June 2023.

House Bill 0927 (pending): This bill was introduced on 10 February 20023 and would ‘decriminalise’ the possession of low levels of certain controlled substances including cocaine, heroin, MDMA, LSD and methadone, changing it from a misdemeanour to a civil fine or a drug education program referral. It was referred to a hearing on 13 February 2023.

In 2021, the City Councils of Somerville, Cambridge, Northampton, and Easthampton, agreed to ‘decriminalise’ the possession of entheogenic plants, including psilocybin mushrooms and ibogaine.

On 11 May 2023, the City Council of Salem voted unanimously to end arrests for psilocybin. The resolution maintains that no city department ‘should use city funds or resources to assist in the enforcement of laws imposing criminal penalties for the use and possession of psilocybin-containing fungi by adults.’ The resolution was vetoed by Salem’s acting mayor due to the resolution (possibly unintentionally) making ‘distribution’ legal. The resolution is intended to be resubmitted. [1]

On 30 March 2023, Massachusetts lawmaker Rep. Nicholas Boldyga (R) filed three psychedelics reform bills including proposals to legalise substances like psilocybin and reschedule MDMA pending federal approval while setting a price cap on therapeutic access:

• House Bill 3589 (pending): concerns the legalisation of certain natural plants and fungi.
• House Bill 3605 (pending): concerns the legal use of the plant medicine known as psilocybin for therapeutic, spiritual, and medicinal purposes.
• House Bill 3574 (pending): concerns the use of a prescription medicine that contains 3,4-methylenedioxymethamphetamine (MDMA).

All three bills have been referred to the Joint Committee on Public Health.

Bill S.1009 (pending): This bill which would ‘decriminalise’ up to 2 grams of psilocybin, psilocyn, DMT, ibogaine, and mescaline for adults over 18, was referred to the Joint Committee on the Judiciary on 16 Feb 2023.

Between 2020 and 2023, Ann Arbor, Washtenaw County, Detroit, Hazel Park, and Ferndale ‘decriminalised’ psychedelic plants and fungi.

On June 8 2023, the Michigan State House introduced concurrent resolution No. 5. The resolution urges Congress, the DoD and the VA to invest in ‘non-technology treatment options for servicemembers and veterans who have psychological trauma as a result of military service.’ The use of psychedelics in clinical settings as a treatment option is referred to specifically. 

Senate File 2995 (enacted): This Act created a psychedelics task force to prepare the state for possible legalisation. It was signed into law by Governor Tim Walz on 24 May 2023.  

House Bill 1154 (pending): This bill supports state research into the use of psilocybin in the treatment of depression, PTSD, substance use disorders, and end-of-life care. It was listed on the House’s Informal Perfection Calendar on 5 May 2023.

On 5 April 2023, Montana lawmakers defeated a House Bill 955 that would have legalised psilocybin therapy for adults with certain medical conditions. However, a more limited measure to study possible psychedelics reforms is being discussed. [2]

SB 242 (enacted): This Act created a new working group to study psychedelics and develop a plan to allow regulated access for therapeutic purposes. It was signed into law by Governor Joe Lombardo on 12 June 2023. 

On 22 December 2020, the New Hampshire Supreme Court vacated the conviction of a man found guilty of possession of psilocybin mushrooms. It held that a lower court failed to properly consider that his use was part of his religious practices, as a member of the Oratory of Mystical Sacraments branch of the Oklevueha Native American Church: The State of New Hampshire v. Mack.

Three recent bills on psychedelic legal reform, House Bill 216, House Bill 328, and House Bill 581 have all been tagged as ‘inexpedient to legislate.’

Bill S2934 (pending): The bill referred to as the ‘Psilocybin Behavioral Health Access and Services Act’ would authorise production and use of psilocybin to promote health and wellness, as well as decriminalising and expunging past offenses involving psilocybin production, possession, use, and distribution. This bill was introduced to the Senate on 23 June 2022 and referred to Senate Health, Human Services and Senior Citizens Committees. 

HB 393 (pending): This bill would establish a ‘Psilocybin Advisory Group’ to be appointed by the Governor, consisting of eight members, responsible for examining the feasibility of creating a mental health focused psilocybin therapy program in New Mexico. It was introduced on 13 February 2023 and referred to the House Health & Human Services Committee (HHHC) and the House Appropriations & Finance Committee (HAFC). On 1 March 2023, the HHHC reported HB 393 with a ‘Do Pass’ recommendation.

House Bill 727 (pending): This bill would establish the Breakthrough Therapies Research Grant Fund with $2.5M in total for qualifying research projects. Grant funds must be used to conduct research in North Carolina on the use of either MDMA or psilocybin, must be concentrated on treating PTSD in veterans, first responders, frontline healthcare professionals, or victims of domestic violence and/or sexual assault, must be concentrated on treating anxiety or depressive disorders, and must also measure pain outcomes. It was introduced on 18 April 2023. 

House Bill 2107 (pending): This bill was approved by the House on 9 March 2023 and sent to the Senate. The Bill promotes a pilot program for research into psilocybin’s therapeutic potential for specific mental health conditions, while also providing legal protections against prosecution for people with eligible conditions. On 29 March 2023, the Senate referred the bill to the Health and Human Services Committee then to the Appropriations Committee.

In November 2020, voters in Oregon passed Ballot Measure 109, allowing the ‘manufacture, delivery and administration’ of psilocybin. This was codified as ORS 475A and directs the Oregon Health Authority to license and regulate the manufacture, transport, delivery, sale, and purchase of psilocybin products.

At the same time, voters also passed Ballot Measure 110 that came into effect on 1 February 2021. It reclassified personal possession of small amounts of drugs as a civil violation with a $100 fine, which can be avoided if the person agrees to seek treatment. For possession of slightly larger amounts of some drugs, the penalty was reduced from a felony to misdemeanour possession.

On 2 January 2023, the Oregon Psilocybin Services Section began accepting applications for licenses.

On 28 March 2023, the Oregon Health Authority (OHA) granted the nation’s first-ever psilocybin production license to Satori Farms PDX LLC for supply to state-supervised psychedelic therapy service facilities.

SB 303 (enacted): This Act was introduced to the Senate on 9 January 2023 and signed into law by Governor Tine Kotek on 6 June 2023. The law allows the collection of aggregate data from licensed psilocybin facilities and provides for the information to be provided to the Oregon Health Authority and Oregon Health and Science University. 

House Bill No. 5923 SUB A (pending): This bill was approved on 12 June 2023 by the House of Representatives. The bill would legalise possession and cultivation of psilocybin mushrooms and take steps to prepare for regulated therapeutic access following federal reform. It has been sent to the Senate Judiciary Committee for consideration.

Senate Bill No. 806: would remove criminal penalties for possessing and cultivating up to one ounce of psilocybin for personal use (including sharing with other adults). It also provides that if the FDA reschedules psilocybin, then the Rhode Island Department of Health ‘shall establish rules and regulations pertaining to cultivation, distribution and medical prescription.’

In March 2023, the following bills were introduced:

• House Bill 4288 (pending): This bill would permit the study of psilocybin, MDMA and ketamine therapy in military veterans with new research partners and over an expanded targeted population.
• House Bill 4423 (pending): This bill aims to create a psilocybin research advisory council and a grants program for clinical trials using whole mushrooms psilocybin for several conditions.
• House Bill 4561 (pending): This bill would create an ‘Alternative Mental Health Therapy Research’ consortium for research into psychedelic assisted therapy for veterans as well as a grants program to establish ketamine clinics for veteran access.

Each bill has been referred to the Public Health Committee.

House Bill 167 (enacted): This Act was signed into law on 22 March 2022 by Governor Spencer Cox and created the Mental Illness Psychotherapy Drug Task Force, tasked with studying and making recommendations on drugs that may assist in treating mental illness. The task force published a report in October 2022 and concluded that MDMA and psilocybin do offer significant benefits to those with mental illness.

Bill H.371 (pending): This bill was introduced on 24 February 2023 and would ‘decriminalise’ psilocybin possession, dispensing and sale and establish a psychedelic therapy advisory working group to study the therapeutic potential of several controlled substances. The bill has been referred to the House Judiciary Committee.

Bill S.114 (pending): This bill was introduced on 1 March 2023 and ‘proposes to make findings regarding the therapeutic benefits of psilocybin, to remove criminal penalties for possession of psilocybin; and to establish the Psychedelic Therapy Advisory Working Group to examine the use of psychedelics to improve physical and mental health’.  The bill also proposes the establishment of a State program similar to Connecticut, Colorado, or Oregon to permit health care providers to administer psychedelics in a therapeutic setting. The bill was referred to the Committee on Health and Welfare.

In January 2022, Seattle City Council approved a resolution to ‘decriminalise’ psilocybin and a wide range of activities relating to psychedelic drugs. The measure extends Seattle’s existing 2021 city policy not to arrest or prosecute personal drug possession relating to ‘religious, spiritual, healing, or personal growth practices.’

On 20 December 2021, Port Townsend followed Seattle’s 2021 policy change and adopted a resolution requesting that ‘investigating, arrest, and prosecution of adults engaging in entheogen-related activities … be a City of Port Townsend low enforcement priority.’

On 2 May 2023, Jefferson County became the first county in the state to ‘decriminalise’ psychedelic plants by making related activities the ‘lowest law-enforcement priority.’

Second Substitute Senate Bill 5263 (enacted): This Act was signed into law by Governor Jay Inslee on 9 May 2023 and provided $1.4 million in pilot project funding for two years. It came into effect on 7 July 2023,  The pilot provides access to psilocybin services to adult veterans and first responders. 

House Bill 2951 (pending): This bill would remove psilocybin, marijuana and THC from the state’s controlled substances list. It was introduced to the House on 24 January 2023 and referred to the Health and Human Resources then Judiciary Committees.