Approximately two weeks after the Department of Justice confirmed it was circulating a proposal to reschedule cannabis to Schedule III of the Controlled Substances Act, Attorney General Merrick Garland submitted the proposed rule to the Federal Register today.
The 92-page draft rule initiates a formal rulemaking process. The public will have 60 days to submit comments on the rule and 30 days to request a hearing by an Administrative Law Judge.
President Joe Biden and Vice President Kamala Harris announced the move in social media videos.
“This is monumental. Today my administration took a major step to reclassify marijuana from a Schedule I to a Schedule III drug. It’s an important move towards reversing longstanding inequities,” Biden said.
“So currently marijuana is classified on the same level as heroin and more dangerous than fentanyl,” Harris said in a separate video. “We are finally changing that. But I want to thank all of the advocates and everyone out there for helping to make this possible. And we are on the road to getting it done.”
DEA seeks more information beyond FDA recommendation
On Oct. 6, 2022, Biden asked Garland and the Secretary of Health and Human Services Xavier Becerra to reconsider marijuana’s placement as a Schedule I drug. Since 1970, it has been in the most restrictive category, making it illegal to possess, manufacture and sell because it has been deemed to have no accepted medical use and a high potential for abuse.
Despite that, 38 states, Washington, D.C., and four U.S. territories have legalized it for medical use. And since 2015, Congress has passed riders prohibiting the DOJ from using funds to enforce federal drug laws in states with legal cannabis programs.
In August, HHS recommended that cannabis be rescheduled to Schedule III, which puts it on the same level as less than 90 mg of codeine, ketamine and anabolic steroids.
The proposed rule, notably signed by Garland himself and not DEA Administrator Anne Milgram, provides an overview of the HHS study and how the findings apply to an eight-factor analysis to determine whether a drug should be controlled.
For a few factors, the DEA noted the need for more information beyond HHS’ findings, such as diversion from legal markets, driving while high, and psychic and physical dependency. It also mentioned opposing federal opinions during previous petitions for scheduling review and other research.
“In addition to HHS’s scientific and medical determinations, which are binding until the issuance of this NPRM [Notice of Proposed Rulemaking] and which must be accorded significant deference throughout the rulemaking, DEA believes that factual evidence (including scientific data) and expert opinions, including additional data regarding different forms, formulations, and delivery methods for marijuana, as well as evidence regarding the effects of marijuana at various dosages or concentrations, may be relevant,” the proposed rule states.
DEA will still be in control
A particular wrinkle is the U.S.’ participation in international drug treaties. Garland sought the opinion of the Office of Legal Counsel, which concluded rescheduling would be allowable.
“OLC has concluded that both the Single Convention and the CSA allow the Attorney General to satisfy the treaty obligations of the United States with respect to marijuana by supplementing scheduling decisions with additional controls under the CSA,” the proposed rule said.
If it is rescheduled, the DEA would continue its existing regulations governing the “registration of manufacturers seeking to plant, grow, cultivate, or harvest marijuana.”
Additionally, the “DEA will consider the marijuana-specific controls” necessary to meet U.S. obligations under the Single Convention and Convention on Psychotropic Substances and, “to the extent they are needed if marijuana is rescheduled, will seek to finalize any such regulations as soon as possible.”
Finally, the proposed rule makes clear that the “manufacture, distribution, dispensing, and possession of marijuana would also remain subject to applicable criminal prohibitions.”
Drugs containing marijuana would still need FDA approval to be lawfully introduced in interstate commerce, unless an Investigational New Drug (IND) application is in effect. While there have been INDs for drugs containing marijuana, no such drugs have been approved by the FDA.
Hilary Bricken, partner at Husch Blackwell law firm who has worked in the cannabis space for 14 years, said in an email that she’s most interested in how the DOJ will handle state-licensed businesses while the DEA claims Schedule III rules still apply.
“Lots to get through in that NPRM, but it’s basically the DOJ/DEA’s defense to administrative challenges on the substance behind the move to S3,” she said. “Will be interesting to see how prohibitionists mount their challenges accordingly.”
