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Marijuana Rescheduling Opponents Slam FDA Process, Saying It Relied On 'Very Bad Studies' - Marijuana Moment

Ben AdlinJune 17, 2024



Leaders of a prohibitionist group spent close to an hour last week publicly complaining that the government’s planned rescheduling of marijuana to Schedule III of the Controlled Substances Act amounted to a politically motivated move, one they said was unsupported by scientific evidence. They’re now weighing “all legal options” to challenge the proposed cannabis move while encouraging supporters to oppose the pending change.


“The process is far from over,” Kevin Sabet, president and CEO of the group Smart Approaches to Marijuana (SAM), said in an online meeting on Wednesday, laying into federal health officials behind the proposal.


“This is something that, you know, you could imagine a legalizer in their basement doing in 1978 based on research then,” he said of the rescheduling recommendation. “This is not 2024. This is not how it’s done. This is not what it is. So there are a lot of things we can do.”


“We are considering all legal options,” he added. “Obviously we’re not gonna reveal the whole legal strategy here in public, but we’re definitely considering all those options.”


SAM staff also encouraged reform opponents to reach out to policymakers to express concerns about the scheduling move. Luke Niforatos, the group’s executive vice president, suggested that the Drug Enforcement Administration (DEA) has already signaled to advocates how to push back on the recommendation.


“They specifically asked for more data and more writing on the concerns related to this change,” Niforatos said, flagging issues such as marijuana potency and cannabis use disorder. “It’s almost like they’re giving a roadmap for how to rebut their own proposed rule… Those are all things you should be including in your public comment.”

“It’s clearly a big debate right now at the administration,” he added.


Since the government’s rescheduling plan was made public in April, SAM has amplified rumors that DEA officials might oppose the proposed change—rumors that a top Biden administration official appeared to acknowledge this month.

In early May, Sabet said he’d heard rumors that DEA Administrator Anne Milgram “did not sign off” on the landmark decision, suggesting that the agency wasn’t on board. As it turned out, Milgram did not put her name on the proposed rescheduling rule, leaving it to Attorney General Merrick Garland to sign the document.

GOP lawmakers in Congress questioned Milgram about the matter during a hearing, but she replied it would be “inappropriate” to comment.

During last week’s SAM event, Sabet acknowledged that any substance with accepted medical use should not be in Schedule I, CSA’s most restrictive category, but also denigrated the Department of Health and Human Services review process that led to the government’s finding that cannabis indeed does have accepted medical uses.

“If you have any accepted medical use, you cannot be in Schedule I, you have to be in II or lower” he said as the meeting began, noting that despite the dangers of opioids, “fentanyl patches have been used in hospitals for decades.”


In terms of marijuana, however, “they’ve totally changed the criteria,” Sabet argued later. “I mean, the studies they use to support medical use are a few very bad studies, basically. Literally a few very bad studies.”


“It’s basically just saying that if it’s popular, then it’s approved, and then it’s accepted,” he said of the government’s review process.

If marijuana is formally moved to Schedule III, Sabet acknowledged that many of the consequences of the move are still unclear.

“Nobody knows what it means,” he said. “God knows what— it’s very unknown what would actually happen if this actually went through.”

One change is that state-legal marijuana firms would be able to claim standard tax deductions for business expenses, much like any other legal industry. Sabet and other panelists warned that the reform would allow the cannabis sector to expand, which they said would lead to more problematic use, more access to marijuana among teens and increased dangers on roadways.

He also downplayed assertions that rescheduling would ease restrictions on research into marijuana.

“It’s true that research would be a little bit easier, but that’s kind of saying, you know, my car, you know, is going to be, you know, a lot safer because, you know, I changed one of my windshield wipers,” Sabet said. “Now, it might be safer, like, one of them might be bad…but if there are a lot of other problems with your car, you know, the windshield wipers, especially if you live in California, aren’t going to be that relevant.”


“What I’m getting at here is that funding is the number one reason why there’s research into any drug,” he explained.


Despite the Biden administration’s statements in support of criminal justice reform around marijuana—the president has said repeatedly, for example, that no one should go to jail for using marijuana—Sabet also argued that the rescheduling change would have little impact on criminal defendants.

“The big difference is the criminal penalties are generally unchanged,” he said. “This idea that like, ‘People in prison…,’ like, ‘We need to change our failed approach…”—it doesn’t actually do that at all. And that’s probably my biggest pet peeve with this, that it’s being touted as we’ll have fewer penalties. That’s not what scheduling does. At all.”

Panelists at the event, all of whom opposed marijuana rescheduling, noted that even legalization advocates have criticized the administration’s framing of the proposed reform. Indeed, some who typically oppose SAM on marijuana policy have said the administration is “mischaracterizing” its reform.


As for what happens next, SAM is holding out hope that DEA could reject the rescheduling recommendation or, alternatively, move marijuana to Schedule II. Sabet pointed to interpretations of international law, for example, that read drug treaties as prohibiting any move outside of Schedules I and II.


DEA took that position in its 2016 denial of an earlier marijuana rescheduling petition, in which the agency wrote that “in view of United States obligations under international drug control treaties, marijuana cannot be placed in a schedule less restrictive than schedule II.”

“Anything is possible,” Sabet said of the possible move to Schedule II. “They could do this as a compromise. They could do that. But we really don’t know.”




He doubted any rescheduling move, despite opening the door to Food and Drug Administration (FDA) regulating marijuana pharmaceuticals, would mean FDA would attempt to interfere with state-legal cannabis markets.


“I can’t imagine FDA’s gonna all of a sudden exercise their administrative power, that they haven’t done, you know, ever on this issue, and go, you know, force pot shops to comply with Schedule III requirements,” Sabet said.

Niforatos, however, called on supporters to urge the federal government to use rescheduling as grounds to go after state-legal operations and shut them down.


“The first thing people should do if this ends up being, you know, what happens,” he said during the meeting, “is asking the Biden administration and DOJ to enforce this change, to enforce Schedule III.”


The proposed rule to federally reschedule marijuana was officially posted last month, kicking off a public comment period that’s expected to elicit a major response with competing perspectives on the reform.

Marijuana reform advocates and stakeholders have made clear that they intend to leverage the opportunity, with some planning to support the reclassification and others intending to call for descheduling cannabis altogether. Prohibitionists like SAM, meanwhile, are expected to oppose the incremental policy change both through lobbying and the threat of litigation.


While DOJ will take all public comments submitted by July 22 into consideration as it weighs the reform, it said in the notice that one of the topics its especially interested in hearing about is the “unique economic impacts” of the rescheduling proposal given that state-level legalization has created a “multibillion dollar industry” that stands to benefit from possible federal tax relief under the reform.


Indications that DEA might not be on board came alongside the rescheduling move itself, with the proposed rule in the Federal Register noting several times that the agency believes “additional information” needs to be collected via public comment or a possible administrative hearing could influence the final scheduling decision.

“DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” the document said.


Even before the formal announcement, it had been reported that certain DEA officials had been “at odds” with the Biden administration over the rescheduling push.


Asked about the status of the proposed move of cannabis to Schedule III of the Controlled Substances Act at a recent event in Sacramento, HHS Secretary Xavier Becerra said his agency made its recommendation based on available science and evidence.


Asked whether there was resistance at DEA, he responded, “Talk to the DEA.”

“Our scientists reviewed the evidence,” Becerra added. “FDA bases its action on the science and the evidence before us. We took action.”


 

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