## Facts

- Marijuana was classified by DEA as a Schedule I controlled substance under the Controlled Substances Act (CSA), which requires, among other things, a finding of “no currently accepted medical use in treatment in the United States.”
- The CSA permits “interested parties” to petition DEA to initiate proceedings to reschedule a controlled substance.
- In October 2002, the Coalition to Reschedule Cannabis petitioned DEA to reschedule marijuana to Schedule III, IV, or V.
- DEA denied the petition in a July 8, 2011 Federal Register notice, concluding there was no currently accepted medical use for marijuana in the United States and that existing clinical evidence was inadequate to warrant rescheduling.
- Americans for Safe Access and other advocacy organizations and individual patients sought judicial review in the D.C. Circuit on July 22, 2011, arguing DEA improperly discounted scientific studies supporting medical use.

## Issues

1. Whether at least one petitioner had Article III standing to seek judicial review of DEA’s final order denying initiation of rescheduling proceedings.
2. Whether DEA’s denial of the rescheduling petition was arbitrary and capricious under the Administrative Procedure Act (APA), including DEA’s interpretation and application of the “currently accepted medical use” requirement.

## Decision

- The court held at least one petitioner had standing, defeating the government’s jurisdictional challenge.
- The court denied the petition for review and upheld DEA’s final order.
- Applying deferential arbitrary-and-capricious review, the court concluded DEA reasonably required “adequate and well-controlled studies proving efficacy” to establish “currently accepted medical use.”
- The court found substantial evidence supported DEA’s determination that the record did not contain such studies sufficient to satisfy DEA’s criteria.

## Legal Principles

- Under the CSA, a substance may not be moved out of Schedule I unless it has a “currently accepted medical use in treatment in the United States.”
- Under the APA, a court must uphold an agency’s action unless it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.
- Courts give substantial deference to an agency’s scientific and technical judgments within its delegated authority, including reasonable interpretations of regulatory criteria used to assess medical acceptance and efficacy.

## Conclusion

The D.C. Circuit upheld DEA’s refusal to initiate proceedings to reschedule marijuana, ruling that DEA’s insistence on adequate, well-controlled efficacy studies as a prerequisite for “currently accepted medical use” was reasonable and that the agency’s evidentiary assessment survived arbitrary-and-capricious review.


Americans for Safe Access v. Drug Enf't Admin., 706 F.3d 438 (D.C. Cir. 2013)