DEA Proposed Rule • Docket DEA1596
Stop Tianeptine From Going Into Schedule I
DEA is proposing permanent Schedule I placement for tianeptine. That would impose the nation's strictest controlled-substance restrictions on a medication prescribed in other countries, create new barriers to research, and expose possession to federal criminal sanctions. Tell DEA to choose an evidence-based and proportionate path.
Creating a comment takes approximately five minutes. You will review and edit every word before submitting it through the official federal docket.
- Comment deadline
- 11:59 p.m. Eastern Time on August 7, 2026
- Federal Register
- 91 FR 42150 • Doc. 2026-13821
- Comment document ID
- DEA-2026-1091-0002
What DEA is proposing
In a notice of proposed rulemaking published on July 8, 2026, the Drug Enforcement Administration, Department of Justice proposed to place tianeptine permanently in Schedule I of the Controlled Substances Act. The proposal covers tianeptine and its specified isomers, esters, ethers, salts, and related salts.
This is not a proposal to restrict retail sales, require a prescription, set manufacturing standards, or impose age limits. Schedule I is the most restrictive federal category, reserved for substances treated as having no currently accepted medical use in the United States.
If finalized, Schedule I controls and sanctions would apply to activities including manufacture, distribution, import, export, research, chemical analysis, and possession.
Why Schedule I matters
Patients and the public
A Schedule I rule would not distinguish between problematic commercial products and the underlying molecule.
Science and research
Researchers handling Schedule I substances face additional registrations, controls, storage requirements, and administrative burdens.
Medical evidence
The proposal concerns a substance that has been used as a prescription medication outside the United States and has been studied in humans.
What the campaign is asking for
Regulation is not the same as prohibition.
- Do not finalize Schedule I placement
- Distinguish the risks of unapproved retail products from the medical and scientific status of tianeptine itself
- Fully consider international prescription experience and human clinical evidence
- Evaluate less restrictive and more proportionate regulatory alternatives
- Preserve lawful medical and scientific research
- Address unsafe products through targeted FDA enforcement, manufacturing standards, labeling, age restrictions, and other proportionate controls
- Consider patient safety, withdrawal risk, and an orderly transition rather than abrupt criminalization
Three ways to act
Submit a Public Comment
Build a substantive, personalized comment and file it in the official docket before the deadline.
Submit a Public CommentContact Congress
Send a short message to your representative and senators, or use a call script.
Contact CongressShare Your Story
Patients, caregivers, clinicians, and researchers can submit an experience for campaign review.
Share Your StoryCampaign activity
Anonymous counters showing how the campaign is being used.
0
Comments generated
0
Comments copied
0
Official comment-form clicks
0
Users confirming submission
0
Congressional letters generated
0
Call scripts generated
0
Stories submitted
0
States represented
0
Campaign shares
These counters are anonymous and contain no comment text, story text, or personal information. A comment generated means someone built a draft on this site. A submission confirmed means someone returned from Regulations.gov and affirmatively confirmed they submitted. This site cannot verify federal submissions. During the MVP phase, counts reflect activity recorded in your own browser only.
Opposing Schedule I Does Not Mean Ignoring Risk
Tianeptine can be misused, and products sold with inaccurate labels or unsupported medical claims can cause serious harm. The question before DEA is not whether risks exist. The question is whether permanent Schedule I prohibition is scientifically justified, proportionate, and protective of patients and research. This campaign supports enforceable product regulation and public-health safeguards—not an unregulated market.
Your experience belongs in the public record.
Federal regulatory comments are generally public. Do not include information you do not want publicly displayed. This website does not provide medical or legal advice.
Write My Comment