Today is another historic day in the history of cannabis control and regulation. In a much anticipated announcement, the Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking to reschedule marijuana, from Controlled Substances Act (CSA) schedule I to schedule III (the “Proposed Rule”).
We have covered the implications of a Schedule III placement in various posts on this blog, beginning with the Health and Human Services (HHS) recommendation that DEA undertake this rescheduling last August. See:
For now, here are a couple of high-level observations on today’s Proposed Rule.
First, DEA is not proposing an interim final rule. We expected as much, but it would have been nice! Under an interim final rule, an agency finds that it has good cause to issue a final rule without first publishing a proposed rule (as DEA did here). An interim final rule would have gone effect immediately upon publication, and marijuana would have been moved to schedule III today. Instead we’ll have to wait.
Second, the Proposed Rule gives a standard 60-day comment period, from the date the Proposed Rule is published in the Federal Register. That’s a pretty standard window; although, as I’ve explained before, this can always be extended.
Third, the Proposed Rule is clear that “any drugs containing a substance within the CSA’s definition of ‘marijuana’ would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act (“FDCA”).” No, this does not mean FDA enforcement is going to begin; and no, this does not mean Big Pharma is coming to squash state licensed operators. Stop saying that.
Fourth, the Proposed Rule gives very specific protocols for submitting electronic and other types of comments. These protocols are not hard to follow! But if you fail to do so, your comment will not make it into the record, and it will not be considered by DEA.
Fifth, I really like this paragraph:
HHS recommended in August 2023 that marijuana be rescheduled to schedule III. See Letter for Anne Milgram, Administrator, DEA, from Rachel L. Levine, M.D., Assistant Secretary for Health, HHS (Aug. 29, 2023) (“August 2023 Letter”). The Attorney General then sought the legal advice of the Office of Legal Counsel (“OLC”) at DOJ on questions relevant to this rulemaking proceeding. Among other conclusions, OLC concluded that “HHS’s scientific and medical determinations must be binding until issuance of a notice of proposed rulemaking [(‘NPRM’)].” Questions Related to the Potential Rescheduling of Marijuana, 45 Op. O.L.C. __, at *25 (Apr. 11, 2024) (“OLC Op.”).1 After the issuance of a notice of rulemaking proceedings, HHS’s scientific and medical determinations are accorded “significant deference” through the rest of the rulemaking process.2 OLC Op. at *26.
I’ve always argued that HHS’s scientific and medical determinations are binding under the plain language of the CSA itself. But it’s awfully nice to hear confirmation that OLC agreed– especially because there was some consternation among the cognoscenti about what OLC was doing here. It seems that OLC has essentially confirmed to DEA: “you are stuck with Schedule III.”
Sixth, it’s interesting to see the Proposed Rule delve into problematic international law constraints. The Proposed Rule gives a rather cursory analysis here, but OLC seems to have justified marijuana’s placement on Schedule III in the context of public international law obligations, including the 1961 U.N. Singled Convention on Narcotic Drugs (to which the United States is a party). DEA states, however, at Proposed Rule page 86 that:
“[c]oncurrent with this rulemaking, DEA will consider the marijuana-specific controls that would be necessary to meet U.S. obligations under the Single Convention and the Convention on Psychotropic Substances in the event that marijuana is rescheduled to schedule III, and, to the extent they are needed if marijuana is rescheduled, will seek to finalize any such regulations as soon as possible.”
This could get pretty interesting! Expect a lot of fretting here by industry and the general public.
Seventh, it was also interesting to see DEA and HHS justify why it arrived at a Schedule III conclusion, after concluding in 2016 that marijuana should stay in schedule I. I have wondered aloud about the intellectual gymnastics that might be required for this. Take a read at the rationale on the Proposed Rule at pages 11 – 13 and see if you’re convinced.
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OK, that’s it for now. The Proposed Rule is 92 pages and I had less than 30 minutes to read it and write this today. We will follow up as soon as next week with further thoughts on this very significant development.
