Groundhog Day: DOI/DOC-->Schedule I?
Long time readers of On Drugs know about 2022’s Five Tryptamines proceeding.1 The best write up about it is here, courtesy of Psychedelic Alpha. In brief:
In January 2022, DEA proposed a rule to put five tryptamine substances into Schedule I based on data evaluated in 2012.
A handful of persons—Mindstate/Tactogen, Panacea Plant Sciences, and Jason Wallach/Hamilton Morris (as to DiPT)—sought a hearing to contest the rule.
After six months of “formal rulemaking” proceedings, bogged down by procedural guffaws, DEA abandoned the proposal to obtain an updated scientific/medical evaluation and scheduling recommendation from HHS.
This withdrawal was unprecedented. Before it, over the past 50 years, DEA had backed off a Schedule I proposal just once, under different circumstances involving the temporary rulemaking of kratom. This was the first time DEA had backed off of a publicly announced Schedule I rulemaking proposal outside of temporary scheduling.
Weeks after the Five Tryptamines retreat, a second withdrawal came. Months before, in April 2022, DEA had similarly announced placing DOI/DOC into Schedule I. This proposal also drew objections. DOI, in particular, is useful in research because it has a high affinity for the 5-HT2A serotonin receptors—regarded as the key classic psychedelic receptor. In the DOI/DOC withdrawal, DEA said little other than it would return with “a new proposed rule using an amended procedure.”
Many of the issues between the Five Tryptamines and DOI/DOC rulemakings were similar. For example, in both, the data to support “high potential for abuse” with respect to compounds was thin. Importantly, however, there were differences. In the Five Tryptamines rulemaking, DEA had relied on stale HHS data over a decade old. Not so with DOI/DOC.2 In both cases, DEA stated that it could come back with a new rule in both cases—but again, for different reasons.
Now, with DOI/DOC, DEA is back.
The new rule proposing placing DOI/DOC is basically the same as the old rule, except this bit:
Hearing requests: All requests for a hearing and waivers of participation, together with a written statement of position on the matters of fact and law asserted in the hearing, must be filed with the DEA Administrator, who will make the determination of whether a hearing will be needed to address such matters of fact and law in the rulemaking. Such requests must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. For informational purposes, a courtesy copy of requests for hearing and waivers of participation should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152
The bolded part is new.3 And, as the resident lawyer with deep familiarity in these matters, color me skeptical that it is lawful.
The Controlled Substances Act at 21 U.S.C. § 811(a) provides that:
Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of title 5. Proceedings for the issuance, amendment, or repeal of such rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary, or (3) on the petition of any interested party.
The bolded statutory phrase refers to an archaic procedure called “formal rulemaking.” Shane wrote a little about it here. In brief, 99.9% of rulemaking today is informal rulemaking, i.e., no hearing and goes through notice-and-comment process via the Federal Register and regulations.gov. Formal rulemaking is a different beast that is “on the record” and presided over by an administrative law judge. See this.
DEA regulations provide that “[a]ny interested person desiring a hearing on a proposed rulemaking, shall, within 30 days after the date of publication of notice of the proposed rulemaking in the Federal Register, file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter.” The regulation does not mention, as the new procedure states, “a written statement of position on matters of law or fact” let alone that the Administrator gets to decide “whether a hearing will be needed.” The statutory language appears to make the hearing non-discretionary and required—nothing in it suggests DEA can bypass a hearing if the Administrator doesn’t think a hearing would be useful. Therefore, in my view, it is unlawful.
To request a hearing, however, a person must show that one is “interested” — which regulations define as “any person adversely affected or aggrieved” by a proposed rule. This called “Administrative Standing.” What does it mean to be a person “adversely affected or aggrieved”? There’s a lot of case law on this. In fact, DEA challenged “administrative standing” in the Five Tryptamine proceedings,4 and the ALJ issued an order deciding the issue in our favor. Note the following points from that order:
A party is not an “interested” based on concern that a substance has a large potential for abuse.
A party’s statement about “lack of information and inappropriate comparisons to other drugs precluded the scheduling” does not establish legal interest.
Parties requesting a hearing have the burden of proving administrative standing.
A party has administrative standing if they are “within the zone of interests” of the particular agency action being challenged, or if they are considered to be protected by the statute in question.
Panacea Plant Sciences was interested because it had ongoing research and projects involving the five tryptamines.
Mindstate/Tactogen were interested as psychedelic pharmaceutical research companies that would be required to obtain registrations to continue their respective projects.
As you noodle over this rulemaking during the holidays, if you decide to seek a hearing, make sure to explain, up front, how/why you are affected/aggrieved by this rule. Don’t be shy. Be specific. The most straightforward way to show administrative standing is use or planning on using these compounds in research, although other interests may suffice. Also, follow the rules—send five copies to DEA as they require. Clearly, this new discretion-of-the-Administrator requirement is gatekeeping designed to make it harder to request a hearing as the law allows.
On substance, from a legal perspective, the main (if only) issue I see is abuse potential. Does DOI (2,5-Dimethoxy-4-iodoamphetamine) have a “high potential for abuse”? DOI doesn’t have the profile of a drug of abuse, and 40 NFLIS Drug Reports for DOI from 2005 to December 2022 and some anecdotal internet evidence doesn’t strike me as powerful evidence.
As important, even assuming a Schedule I placement could be legally justified, it is bad policy. DOI, which isn’t widely abused, can be effectively regulated as an analogue when sold for human consumption. Even assuming a Schedule I placement could be made with DOI, it shouldn’t be made as a practical matter.
I participated in these proceeding as an attorney representing Mindstate/Tactogen.
Also, the Five Tryptamines involved the company-formerly-known-as-first-Field-Trip-then-Reunion-now-nothing arguing why its compound shouldn’t be scheduled, but concurring with DEA on the other four. In a karmic twist of face, the Five Tryptamines parties are still doing their thing; Field Trip/Reunion is not.
Can DEA create new procedures on-the-fly without notice-and-comment? Probably. But they must still be consistent with the statute.
DEA hasn’t published the filings from the Five Tryptamines and other agency proceedings—that’s one reason why I am suing it. But, as an attorney from the proceedings, I have the filings and posted them in full. I’d definitely read Shane’s declaration, which has some helpful legal points to consider. And, if you find it useful—there are arguments/issues germane to the DOI/DOC proceedings among them—you should consider becoming a paid subscriber.
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