{"id":76388,"date":"2024-06-17T07:50:04","date_gmt":"2024-06-17T15:50:04","guid":{"rendered":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2024\/06\/17\/marijuana-rescheduling-opponents-slam-fda-process-saying-it-relied-on-very-bad-studies\/"},"modified":"2024-06-17T12:45:52","modified_gmt":"2024-06-17T20:45:52","slug":"marijuana-rescheduling-opponents-slam-fda-process-saying-it-relied-on-very-bad-studies","status":"publish","type":"post","link":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2024\/06\/17\/marijuana-rescheduling-opponents-slam-fda-process-saying-it-relied-on-very-bad-studies\/","title":{"rendered":"Marijuana Rescheduling Opponents Slam FDA Process, Saying It Relied On \u2018Very Bad Studies\u2019"},"content":{"rendered":"<\/p>\n

Leaders of a prohibitionist group spent close to an hour last week publicly complaining that the government\u2019s 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\u2019re now weighing \u201call legal options\u201d to challenge the proposed cannabis move<\/a> while encouraging supporters to oppose the pending change.<\/p>\n

\u201cThe process is far from over,\u201d 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.<\/p>\n

\u201cThis is something that, you know, you could imagine a legalizer in their basement doing in 1978 based on research then,\u201d he said of the rescheduling recommendation. \u201cThis is not 2024. This is not how it\u2019s done. This is not what it is. So there are a lot of things we can do.\u201d<\/p>\n

\u201cWe are considering all legal options,\u201d he added. \u201cObviously we\u2019re not gonna reveal the whole legal strategy here in public, but we\u2019re definitely considering all those options.\u201d<\/p>\n

SAM staff also encouraged reform opponents to reach out to policymakers to express concerns about the scheduling move. Luke Niforatos, the group\u2019s executive vice president, suggested that the Drug Enforcement Administration (DEA) has already signaled to advocates how to push back on the recommendation.<\/p>\n

\u201cThey specifically asked for more data and more writing on the concerns related to this change,\u201d Niforatos said, flagging issues such as marijuana potency and cannabis use disorder. \u201cIt\u2019s almost like they\u2019re giving a roadmap for how to rebut their own proposed rule\u2026 Those are all things you should be including in your public comment.\u201d<\/p>\n

\u201cIt\u2019s clearly a big debate right now at the administration,\u201d he added.<\/p>\n

Since the government\u2019s rescheduling plan was made public in April, SAM has amplified rumors that DEA officials might oppose the proposed change\u2014rumors that a top Biden administration official appeared to acknowledge this month<\/a>.<\/p>\n

In early May, Sabet said he\u2019d heard rumors that DEA Administrator Anne Milgram \u201cdid not sign off\u201d on the landmark decision<\/a>, suggesting that the agency wasn\u2019t 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.<\/p>\n

GOP lawmakers in Congress questioned Milgram about the matter during a hearing<\/a>, but she replied it would be \u201cinappropriate\u201d to comment.<\/p>\n

During last week\u2019s SAM event, Sabet acknowledged that any substance with accepted medical use should not be in Schedule I, CSA\u2019s most restrictive category, but also denigrated the Department of Health and Human Services review process that led to the government\u2019s finding that cannabis indeed does have accepted medical uses.<\/p>\n

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\u201cIf you have any accepted medical use, you cannot be in Schedule I, you have to be in II or lower\u201d he said as the meeting began, noting that despite the dangers of opioids, \u201cfentanyl patches have been used in hospitals for decades.\u201d<\/p>\n

In terms of marijuana, however, \u201cthey\u2019ve totally changed the criteria,\u201d Sabet argued later. \u201cI mean, the studies they use to support medical use are a few very bad studies, basically. Literally a few very bad studies.\u201d<\/p>\n

\u201cIt\u2019s basically just saying that if it\u2019s popular, then it\u2019s approved, and then it\u2019s accepted,\u201d he said of the government\u2019s review process.<\/p>\n

If marijuana is formally moved to Schedule III, Sabet acknowledged that many of the consequences of the move are still unclear.<\/p>\n

\u201cNobody knows what it means,\u201d he said. \u201cGod knows what\u2014 it\u2019s very unknown what would actually happen if this actually went through.\u201d<\/p>\n

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.<\/p>\n

He also downplayed assertions that rescheduling would ease restrictions on research into marijuana.<\/p>\n

\u201cIt\u2019s true that research would be a little bit easier, but that\u2019s 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,\u201d Sabet said. \u201cNow, it might be safer, like, one of them might be bad\u2026but if there are a lot of other problems with your car, you know, the windshield wipers, especially if you live in California, aren\u2019t going to be that relevant.\u201d<\/p>\n

\u201cWhat I\u2019m getting at here is that funding is the number one reason why there\u2019s research into any drug,\u201d he explained.<\/p>\n

Despite the Biden administration\u2019s statements in support of criminal justice reform around marijuana\u2014the president has said repeatedly, for example, that no one should go to jail for using marijuana\u2014Sabet also argued that the rescheduling change would have little impact on criminal defendants.<\/p>\n

\u201cThe big difference is the criminal penalties are generally unchanged,\u201d he said. \u201cThis idea that like, \u2018People in prison\u2026,\u2019 like, \u2018We need to change our failed approach\u2026\u201d\u2014it doesn\u2019t actually do that at all. And that\u2019s probably my biggest pet peeve with this, that it\u2019s being touted as we\u2019ll have fewer penalties. That\u2019s not what scheduling does. At all.\u201d<\/p>\n

Panelists at the event, all of whom opposed marijuana rescheduling, noted that even legalization advocates have criticized the administration\u2019s framing of the proposed reform. Indeed, some who typically oppose SAM on marijuana policy have said the administration is \u201cmischaracterizing\u201d its reform<\/a>.<\/p>\n

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<\/a>.<\/p>\n

DEA took that position in its 2016 denial of an earlier marijuana rescheduling petition, in which the agency wrote that \u201cin view of United States obligations under international drug control treaties, marijuana cannot be placed in a schedule less restrictive than schedule II.\u201d<\/p>\n

\u201cAnything is possible,\u201d Sabet said of the possible move to Schedule II. \u201cThey could do this as a compromise. They could do that. But we really don\u2019t know.\u201d<\/p>\n

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.<\/p>\n

\u201cI can\u2019t imagine FDA\u2019s gonna all of a sudden exercise their administrative power, that they haven\u2019t done, you know, ever on this issue, and go, you know, force pot shops to comply with Schedule III requirements,\u201d Sabet said.<\/p>\n

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.<\/p>\n

\u201cThe first thing people should do if this ends up being, you know, what happens,\u201d he said during the meeting<\/a>, \u201cis asking the Biden administration and DOJ to enforce this change, to enforce Schedule III.\u201d<\/p>\n

The proposed rule to federally reschedule marijuana was officially posted last month, kicking off a\u00a0public comment period that\u2019s expected to elicit a major response<\/a> with competing perspectives on the reform.<\/p>\n

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.<\/p>\n

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\u00a0the \u201cunique economic impacts\u201d of the rescheduling proposal<\/a>\u00a0given that state-level legalization has created a \u201cmultibillion dollar industry\u201d that stands to benefit from possible federal tax relief under the reform.<\/p>\n

Indications that\u00a0DEA might not be on board came alongside the rescheduling move itself<\/a>, with the proposed rule in the Federal Register noting several times that the agency\u00a0believes \u201cadditional information\u201d needs to be collected via public comment or a possible administrative hearing could influence the final scheduling decision.<\/p>\n

\u201cDEA has not yet made a determination as to its views of the appropriate schedule for marijuana,\u201d the document said.<\/p>\n

Even before the formal announcement, it had been reported that certain DEA officials had been\u00a0\u201cat odds\u201d with the Biden administration over the rescheduling push<\/a>.<\/p>\n

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<\/a>.<\/p>\n

Asked whether there was resistance at DEA, he responded, \u201cTalk to the DEA.\u201d<\/p>\n

\u201cOur scientists reviewed the evidence,\u201d Becerra added. \u201cFDA bases its action on the science and the evidence before us. We took action.\u201d<\/p>\n

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Marijuana Legalization Opponents Raise Money For Potential Lawsuit Against Federal Rescheduling Move<\/a><\/p>\n<\/blockquote>\n

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Photo courtesy of Philip Steffan<\/a>.<\/em><\/p>\n

The post Marijuana Rescheduling Opponents Slam FDA Process, Saying It Relied On \u2018Very Bad Studies\u2019<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n


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Leaders of a prohibitionist group spent close to an hour last week publicly complaining that the government\u2019s 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\u2019re now weighing \u201call legal options\u201d toContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":24,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81,126],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/76388"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=76388"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/76388\/revisions"}],"predecessor-version":[{"id":76389,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/76388\/revisions\/76389"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=76388"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=76388"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=76388"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}