DEA Acknowledges New Two-Step Test For Marijuana’s Accepted Medical Use Is Legitimate

Even as some opponents of marijuana reform attack the review process that led federal health officials to recommend rescheduling cannabis, the Drug Enforcement Administration (DEA) is now acknowledging the legitimacy of the new two-part test used to determine a substance’s accepted medical use.

The agency’s admission came in a footnote tucked into a Tuesday notice about an unrelated move to place a pair of synthetic opioid drugs under Schedule I of the Controlled Substances Act (CSA).

Under federal law, a Schedule I drug is one that has no currently accepted medical use (CAMU). In the past, the government has relied on a five-part test to determine whether a substance meets that standard—one that looks at a drug’s chemistry, available health data and other details. But earlier this year, when considering the proposed rescheduling of marijuana, the Department of Health and Human Services (HHS) introduced a new, simplified two-step analysis that led it to conclude cannabis belongs in Schedule III.

In May, the Department of Justice’s (DOJ) Office of Legal Counsel (OLC) said the prior five-part test was “impermissibly narrow” and said the two-part review “is sufficient to establish that a drug has CAMU even if the drug has not been approved by FDA and would not satisfy DEA’s five-part test.”

It also determined that HHS’s rescheduling recommendation is binding on DEA, even as the agency has expressed that it is not necessarily on board with the reform—but only until a formal rulemaking process is initiated. But even after that point, “DEA must continue to accord HHS’s scientific and medical determinations significant deference.”

Many who oppose marijuana rescheduling have attacked the two-part analysis as unjustified, tailored for political reasons to prop up the cannabis reform. The prohibitionist group Smart Approaches to Marijuana (SAM), for example, has called the two-part standard a “novel test” that was “recently invented by HHS and embraced” as a means to the predetermined end of moving marijuana to Schedule III.

Some observers have suggested that going after the revised analysis method could be a line of attack in a potential legal challenge to the rescheduling recommendation.

But in DEA’s new scheduling notice for the two synthetic benzimidazole-opioid substances—N-pyrrolidino metonitazene and N-pyrrolidino protonitazene—the agency seems to recognize the two-part test as sufficient.

“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,” DEA officials wrote in a footnote in the document.

As the agency describes in the footnote, the earlier test hinged on five factors:

“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.”

The two-part analysis, by contrast, rests on just two questions, as DEA explained:

“(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.”

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 and 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.”

In other words, he added, “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.”

“It doesn’t mean that DEA doesn’t, deep in its heart, oppose that standard and think it’s wrong,” the lawyer added. But the acknowledgement still stands: “They’re citing OLC. They seem to recognize it’s a standard.”

Pennington noted that because the government’s marijuana rescheduling proposal is still pending—and could still be challenged in court—the matter isn’t quite settled. But for now, throwing out the two-part test would require action by “OLC, the attorney general, the president, a federal court or Congress—you know, like somebody way up.”

“Other than that,” he continued, “it would be very, very bizarre and probably indefensible for them to change their position.”

That, in turn, could even have implications for future drug scheduling reviews, Pennington said, such as those concerning psychedelics.

“Say psilocybin’s up for rescheduling,” Pennington explained. “They would have to apply the same standard.”

Meanwhile this week, President Joe Biden (D) himself recognized explicitly that the rescheduling process he initiated isn’t a done deal just yet.

Following a public comment period, the Drug Enforcement Administration (DEA) last month announced that it has scheduled an administrative hearing in December to gain additional input before potentially finalizing the rule. It’s possible that rulemaking could extend into January, meaning there’s a chance that the next presidential administration could influence the final outcome.

While the current president has repeatedly taken credit for the marijuana pardon actions he’s taken, it’s relatively rare to hear him speak about the rescheduling push. He addressed it when the proposed rule was released and in a proclamation this year designating April as “Second Chance Month,” but he’s generally focused on separate clemency work in recent years.

Biden’s latest comments reflect a reality about the current status of the rescheduling process that was missed in a post by the Democratic National Committee (DNC) in July. DNC played up the Biden-Harris administration’s marijuana reform platform, but it got some pushback after suggesting that cannabis had already been rescheduled and that the country’s “failed approach” to marijuana had ended.

Harris also faced criticism from advocates in February after she similarly claimed that the administration had “changed federal marijuana policy” in a video meant to appeal to young voters.

While the campaign seems willing to call out Trump on his marijuana platform, it’s been notably silent on the 2024 Democratic nominee’s own position—even though she privately reaffirmed her support for legalization during a roundtable event at the White House event with marijuana pardon recipients in March and also sponsored a bill to end federal prohibition during her time in the Senate.

Advocates have also taken notice that a new, long-awaited issues page launched by the Harris campaign omits any mention of marijuana policy reform despite her record promoting comprehensive legalization.

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