The question of what to do with marijuana that is not approved for medical use by the FDA or a state licensing authority is the subject of a public hearing beginning June 29th at the DEA headquarters. The hearing will be presided over by an administrative law judge (ALJ) whose nonbinding findings and recommendations will be given to the DEA Administrator, who then must decide in the public interest whether to maintain marijuana in Schedule I of the Controlled Substances Act (CSA) or move it to Schedule III of the Act.
On April 28, 2026, a Final Rule was issued by the DEA and the Acting Attorney General to comply with the President’s Executive Order No. 14370, issued December 18, 2025, and to reschedule FDA-approved marijuana and marijuana products approved by a state licensing authority to Schedule III. Thus, what to do about marijuana that is not covered by this Final Rule, that is, marijuana that is not FDA-approved or approved by a state licensing authority, is what the witnesses at the DEA’s hearing are expected to testify about.
On June 24, 2026, I, John J. Coleman, PhD, a retired special agent and former Assistant Administrator of the DEA, offered an Amicus Curiae brief that, among other things, described legislation signed into law by President Bill Clinton in 2000, and titled “Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000 (Act).” The Act was named for two teenage girls who died after being given gamma hydroxybutyric acid (GHB), considered a “date-rape” drug, surreptitiously in their soft drinks by male companions.
GHB was described in the Act as a behavioral depressant and a hypnotic. It is illicitly produced from industrial chemicals and sold by traffickers in the U.S. and elsewhere. The Act to control it had broad bipartisan support, passing in the House by a vote of 339 to 2.
The Act directed the Attorney General, through the DEA Administrator, to place GHB in Schedule I of the CSA using the CSA’s emergency scheduling provision. Prior to this, the Food and Drug Administration (FDA) had approved an Investigational New Drug application for a medicinal product containing a GHB salt that was under development. To allow for this, the Act authorized the placement of GHB in Schedule III if and when an FDA-approved version became available.
Less than a month later, on March 13, 2000, the DEA published a Final Rule “placing gamma-hydroxybutyric acid (GHB) and its salts, isomers, and salts of isomers into Schedule I of the Controlled Substances Act (CSA) pursuant to Public Law 106–172.” The same Final Rule placed “FDA-approved products containing GHB into Schedule III, if or when they are approved.” Subsequently, the FDA approved Xyrem® (Jazz Pharm.), a GHB drug, and the DEA placed it in Schedule III of the CSA.
GHB provides us with an important precedent for what should be done with marijuana that is not approved for medical use by the FDA or a state licensing authority. As with GHB, marijuana that is not approved must remain in Schedule I, whereas marijuana approved for medical use by the FDA or a state-licensing authority, like Xyrem, can remain in Schedule III.
An important takeaway message from the GHB story is that Congress did not schedule the drug itself, as it could have done and did, for example, in 1990, with anabolic steroids, but, instead, it directed the Attorney General and the DEA to do so using the scheduling provisions of the CSA.
The second issue addressed in my Amicus brief addressed U.S. treaty obligations under the Single Convention on Narcotic Drugs, a UN treaty adopted in 1961 and ratified by the U.S. Senate in 1967. Compliance with this 65-year-old treaty appears to be the driving force behind the current and previous administrations’ desire to reschedule marijuana.
According to the Single Convention, cultivation of marijuana by signatories is permitted for medical and scientific purposes only. To show this, the Amicus brief cites seven provisions in the Single Convention in which signatories agreed to prohibit the cultivation and wholesale trade in covered drugs, including cannabis, except for medical and scientific purposes.
For example, Article 2 of the treaty states:
A Party shall … prohibit the production, manufacture, export and import of, trade in, possession or use of any such drug except for amounts which may be necessary for medical and scientific research only…. [Article 2, paragraph 5b]
Acknowledging that it might take some parties longer to implement their obligations, Article 49 of the treaty states:
The use of cannabis for other than medical and scientific purposes must be discontinued as soon as possible, but in any case within twenty-five years from the coming into force of this Convention. The Single Convention came into force on December 13, 1964 (and was ratified by the U.S. Senate in 1967).
By rescheduling marijuana approved for medical use to Schedule III to comply with the Single Convention, the U.S. has a corresponding treaty obligation to prohibit marijuana that is not approved for medical use. Thus, as in the example presented in the GHB matter, marijuana that is not approved for medical use, according to the same reasoning, must remain in CSA Schedule I.