Drug Control: DEA Should Improve Its Religious Exemptions Petition Process for Psilocybin (Mushrooms) and Other Controlled Substances

What GAO Found

Psilocybin is a naturally occurring hallucinogenic substance found in certain types of mushrooms. Generally, it is a federal crime for any person to possess, manufacture or distribute this controlled substance. However, numbers of investigations and seizures for psilocybin are small compared to other Schedule I controlled substances. During fiscal years 2018 through 2023, psilocybin cases (identified as the harshest or primary drug of concern) represented less than 1 percent of all cases the Drug Enforcement Administration (DEA) investigated and closed. Over the same period, psilocybin accounted for about 2 percent of all the U.S. Customs and Border Protection's drug seizures.

Depiction of Various Forms of Psilocybin (Mushrooms)

Selected stakeholders reported several barriers to the legal access and use of psilocybin for religious practices under the Religious Freedom Restoration Act. For example, DEA established a process for parties to petition for a religious exemption from the Controlled Substances Act to use controlled substances for religious purposes. However, DEA's guidance does not inform petitioners on its timeframes to make determinations on completed petitions. DEA officials stated the agency is aware of public concerns on the need to better understand its policies and processes that impact the petitions for religious exemptions. In 2019, DEA initiated a draft notice of proposed rulemaking related to its process for petitioning for religious exemptions. The draft notice was submitted to DEA's Office of the Administrator, according to DEA officials; but there is no timeframe for issuance of the notice or final regulations.

Over an 8-year period—from fiscal year 2016 through January 2024—DEA reported that 24 petitioners requested a religious exemption for various controlled substances. As of January 2024, DEA reported that none of these petitions had been granted an exemption and of the 6 for psilocybin, three were withdrawn and three were pending a DEA determination. The three pending religious exemption petitions related to psilocybin ranged from about 8 months to over 3 years from the date of receipt. DEA's information also showed instances where finalized actions regarding exemption petitions related to other controlled substances have been pending a determination for an extensive period—one almost 5 years and one almost 8 years.

Including timeframes to make determinations about religious exemption petitions in DEA's guidance will provide better transparency about the agency's process.

Why GAO Did This Study

DEA is responsible for investigating and enforcing violations of the Controlled Substances Act; overseeing, and coordinating with the Food and Drug Administration (FDA), on the process to study controlled substances; and reviewing petitions for religious exemptions to the Controlled Substances Act. Historically, psilocybin has been used in Indigenous cultures for spiritual ceremonies. Some states have taken steps to legalize the adult use of psilocybin or establish programs to study psilocybin for therapeutic applications.

The Joint Explanatory Statement accompanying the Consolidated Appropriations Act, 2023, includes a provision for GAO to review the use of psilocybin. Among other objectives, this report addresses (1) what federal data show on psilocybin's enforcement; and (2) reported barriers to the legal access and use of psilocybin for religious practices under the Religious Freedom Restoration Act.

GAO analyzed data from DEA related to enforcement and religious exemption processes, and interviewed officials at DEA, FDA, research institutions, selected individuals from law firms and advocacy organizations; and officials from two states that legalized psilocybin use.