What Appeared as a Not Unusual Entry in the Federal Register
It appears to have been a fairly routine administrative publication, today, September 17, 2024, on temporary scheduling of yet another set of opioid-like New Psychoactive Substances (NPSs) which Enthereal’s founder previously covered when NPS surveillance revealed the emergence of nitazenes; mainstream media coverage of nitazenes appeared at CBS, among other news outlets, back in December. The DEA, today, scheduled 2 more of these opioid-like substances: September 17, 2024, Federal Register entry on Temporary Scheduling of 2 more Nitazenes:
And, sometimes, it’s worth reading the fine print, because in those footnotes:
DEA brass, for the first time acknowledged, “On April 11, 2024, the Department of Justice’s Office of Legal Counsel (OLC) issued an opinion, which, among other things, concluded that HHS’s two-part test would be sufficient to establish that a drug has a currently accepted medical use,” in the notice’s footnote.
Wider Implications of New 2-part Test
This may have more broad implications for rescheduling of other substances besides cannabis-associated ones.
The newer 2-part test from DEA – which we should all be parsing for how it pertains to other Schedule substances that do have medical use and satisfy the elements of the new test:
“(1) whether there exists widespread, current experience with medical use of the substance by licensed health care providers operating in accordance with implemented jurisdiction-authorized programs, where medical use is recognized by entities that regulate the practice of medicine, and, if so, (2) whether there exists some credible scientific support for at least one of the medical conditions for which part (1) is satisfied.”
Marijuana Moment: “Some legal observers see DEA’s acknowledgement of the two-part test as a tacit acceptance by the agency of OLC’s looser standard for currently accepted medical use.”
Shane Pennington, an attorney in the Washington, D.C. office of Porter Wright Morris & Arthur LLP who specializes in federal administrative law, told Marijuana Moment that the new memo shows that “DEA is bound by OLC on legal issue, because OLC speaks with authority to the entire executive branch unless it’s overruled by the attorney general or the president.”
Shane contextualized: “it means that they recognize that they’re bound by a higher authority” and must accept the two-part review. “It’s something. It’s not nothing,” Pennington said. “To me, it was significant because it’s the first time they’ve acknowledged that test.”
As written in the footnote, the previous test included five elements:
“i. The drug’s chemistry must be known and reproducible; ii. there must be adequate safety studies; iii. there must be adequate and well-controlled studies proving efficacy; iv. the drug must be accepted by qualified experts; and v. the scientific evidence must be widely available.”
Implications for Other Substances than Cannabis
Enthereal does not provide legal advice! However, seems from the statements by the legal observers quoted above and their analysis, there is now — until OLC issues another opinion or courts modify that policy — a pathway for rescheduling not only cannabis but other Schedule I or potentially-scheduled substances to be placed somewhere other than Schedule I, if they meet the new 2-part test.
Enthereal is a pre-seed stage startup focused on sustainability and accessibility of wellness and health empowerment with models that inherently include more people.
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