On September 23, the DEA proposed placing five tryptamines in Schedule I: 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT. Scheduling is a formal rulemaking “on the record,” and a final rule is reviewed for substantial evidence. So I read the notice for what it concedes:
- The evidence is pooled across five substances. For 4-OH-DiPT it is one multi-substance poison-center case. For DiPT it is two.
- The DEA says diversion “is not applicable” and that dependence liability cannot be determined.
- Human effects rest on “anecdotal reports usually on internet forums.”
- The finding that people use these substances without medical advice is assumed because the substances are unapproved, which is circular.
- The small-business analysis divides by entire industries, and its own footnote says 0.02% where the text says 0.18%.
The comments are due October 23 at regulations.gov under docket DEA1715. You don’t need standing or evidence to file.
Here is the comment I filed.
Full text
COMMENT IN OPPOSITION
I am a member of the public and I oppose the proposed rule. It lacks the substantial evidence that 21 U.S.C. 811(a), 812(b)(1), and 877 require, and its reasoning is circular or admittedly incomplete. I ask DEA to withdraw it or, at minimum, to respond to each numbered point below in any final rule. I incorporate by reference all other comments and hearing requests in this docket and in the 2022 proceeding on the same substances (87 FR 2376; 87 FR 40167; 87 FR 45076).
- DEA made no findings for each substance.
Sections 811(a) and 812(b) require findings “with respect to such drug or other substance.” The notice instead pools all five, reporting 65 poison-center exposures and 518 law enforcement encounters in aggregate, with no per-substance breakdown. By the notice’s own account, the only poison-center evidence for 4-OH-DiPT is “one multi-substance case,” and for DiPT it is two single-substance cases. No single-substance exposure to any of the five resulted in death, and the one cited death (5-MeO-AMT, 2004) involved alcohol and bupropion. The notice cannot support a finding of high abuse potential for 4-OH-DiPT or DiPT on one or two exposures over two decades. It also describes the exposure period inconsistently (“2000-2021” at 60341, “January 1, 2003, to December 31, 2021” at 60343).
- DEA concedes most indicators of abuse are absent or unknown.
DEA states that diversion “is not applicable,” that it “is not possible to determine” whether the substances produce physiological dependence, and that psychological dependence assessment was “limited due to lack of available data.” No formal clinical studies exist for three of the five, and human effects rest on “anecdotal reports usually on internet forums.” The claimed risk to motor vehicle operation cites no incident. A finding of “high potential for abuse” cannot rest on this record.
- The “own initiative” finding is circular.
DEA reasons that because the substances are unapproved, people must be taking them without medical advice, and then says “it is assumed” this is so. Legal status is not evidence of abuse. The same reasoning would justify Schedule I placement for any unapproved compound and would make the statutory criteria meaningless.
- Structural analogy does not replace evidence.
The notice relies largely on resemblance to DMT, DET, DOM, and LSD, while conceding the five “may differ by potency,” onset, and duration. After Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), DEA’s reading of the undefined term “abuse” gets no deference, and its four criteria come from a 1970 House report and not the statute. DEA must explain why resemblance satisfies the statute when its own evidence on the other criteria is negative or unknown.
- “Safety not determined” is not “lack of accepted safety.”
The notice finds that safety “is not determined” and concludes there is “a lack of accepted safety.” Missing data shows that a question is unanswered, not that experts reject safety. Section 812(b)(1)(C) requires an affirmative finding, and DEA must explain why it treats the two as equivalent.
- The data are stale and the reversal is unexplained.
The poison-center data end in 2021. The notice explains withdrawing the 2022 proposal and hearing only as “upon further consideration.” DEA should explain what changed and why the record remains reliable (Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29 (1983)).
- The Regulatory Flexibility Act certification is defective.
DEA compares 25 suppliers to every firm in three entire NAICS industries and not to the entities the rule regulates. Its arithmetic is inconsistent: the text says 0.18 percent and footnote 20 says 0.02 percent for the same calculation. Its claim about researchers rests on an unsupported expectation that they “probably” already hold registrations. Section 605(b) requires a factual basis for certification, and the notice offers only conclusions.
- Procedural requests.
Please place in the docket every document DEA relied upon, including per-substance NFLIS data and the complete NPDS extract, and extend the comment period to allow review. Please respond in any final rule to each numbered objection and every other significant comment (Ohio v. EPA, 603 U.S. 279 (2024)).
Conclusion
DEA has not shown, substance by substance, the findings Congress requires for Schedule I. I ask DEA to withdraw the proposed rule.
