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The title of this post comes, of course, from The Who’s classic track “Won’t Get Fooled Again.” This post analyzes whether there is cause for worry on the part of cannabis operators – both marijuana and hemp – under a second Trump presidency. So, I guess the first question is whether cannabis operators got fooled during the first Trump regime.

In my opinion, the short answer is no – in fact, marijuana operators were allowed to operate under policies similar to the Obama administration and the 2018 Farm Bill allowed for an explosion of the hemp industry. But the answer is also that the cannabis industry was complicated then and much more complicated now. With a new Farm Bill on the horizon – with a new Congress – and rescheduling hearings on marijuana scheduled early next year, along with the myriad issues sure to arise in the cannabis industry over the next four years, what will be the impact of a Trump presidency on critical cannabis questions? Let’s dive in.

Leading up to the 2020 election, we predicted what a Trump presidency would mean for the cannabis industry:

The answer is far from clear given Trump and his administration’s drug policy decisions over the course of the president’s first term. These decisions range, on the one hand, from signing into law a bill federally legalizing hemp after decades of prohibition to, on the other hand, appointing a fierce opponent of cannabis legalization as U.S. attorney general. These decisions paint a potentially conflicting picture of the president, who once said all drugs should be legal, and his ongoing policy toward cannabis.

The answer to determining what a second-term Trump presidency would mean for cannabis legalization requires separating the president’s comments from his administration’s actions. The president has made conflicting comments on marijuana legalization throughout his presidency, but his administration has offered a steadier picture of where a second-term Trump presidency would lead. The short answer appears to be more of the same.

One of the Trump administration’s most significant cannabis developments to occur during his first term was signing the 2018 Farm Bill. This move legalized hemp creating a massive market for a crop that had been prohibited for more than 80 years as a federally controlled substance. Trump’s U.S. Department of Agriculture has further supported hemp by allocating significant resources into implementing the reform.

Although many industry advocates were troubled by then U.S. Attorney General Jeff Sessions’ decision to rescind the Cole Memorandum — an Obama-era policy of non-federal interference with states who have legalized marijuana — the suspected effect of the rescission has not been realized. In fact, current Attorney General William Barr has said that he is not interested in disturbing “settled expectations” as it concerns the Cole Memorandum era policy, even though it is no longer in effect. Seeing as how there have not been any large-scale federal raids of state-level legal cannabis businesses, it seems reasonable to assume this policy of federal inaction toward state legalization will continue.

On the campaign trail, rather than directly addressing cannabis policy, Trump portrayed himself as the criminal justice reform candidate. He has focused his message around the First Step Act, which ushered in federal sentencing reforms for certain drug offenses.

Trump’s own comments, in public and private, offer a mixed bag toward his views on cannabis legalization. For instance, in 2018, when asked if he supported a bipartisan bill to allow states to set their own marijuana policies, the president said, “I really do.”  But this contrasts with comments the president made at an August 2020 campaign rally urging Republicans not to place marijuana legalization initiatives on state ballots out of concern that it would increase Democratic turnout in elections.

During his first term, Trump has shown himself to be not so much a cannabis ally as much as a cannabis ambivalent. The president likely doesn’t think cannabis should be illegal, but he also seems willing to use the issue as a cudgel to rally his base. A second Trump term would likely mean more of the same, a lukewarm and at times inconsistent policy toward cannabis.

Earlier this year, profiling a matchup between Trump and President (and then Democratic nominee) Joe Biden, we reiterated our initial analysis and noted:

[W]e believe the same spirit is as true today as ever regardless of the occupant of the White House. We opened this piece by noting that we stridently seek to avoid taking partisan positions, but we’re going to call a spade a spade. The American people support cannabis liberalization. Neither candidate Trump nor candidate Biden seem to personally view the issue as top of mind, but nor will either apparently stand in the way of liberalization.

So, in the end, maybe all of this discussion was for naught. Maybe the results will be the same regardless of who calls 1600 Pennsylvania Avenue home on January 21, 2025. Maybe what really matters is who controls Congress, who controls the statehouses, and who controls the judicial branches that interpret the law.

We think that is probably about where we stand today. It’s noteworthy, but not necessarily dispositive, that then-candidate Trump recently expressed support for an amendment to the Florida Constitution that could have allowed for an adult-use marijuana regime. Posting on Truth Social, Trump stated:

As a Floridian, I will be voting YES on Amendment 3 this November.

The amendment, which would have allowed “adults 21 years or older to possess, purchase, or use marijuana products and marijuana accessories for non-medical personal consumption,” did not receive the requisite 60% of the vote to become law. Does Trump’s support of the Florida amendment signal his support of a nationwide policy of marijuana liberalization or does it reflect his view on an issue that he believes should be left to the states to determine? We shall soon see.

There are perhaps three more consequential developments for the cannabis industry in the coming months and years. First, who Trump chooses to run the agencies tasked with governing cannabis policy at the federal level – primarily, the Department of Justice, the Drug Enforcement Administration, and the Food and Drug Administration. Those regulators will have tremendous influence both on broad federal policies but also on day-to-day decisions regarding cannabis enforcement decisions.

Second, as we have written about extensively, the federal government is in the process of determining whether marijuana should be rescheduled from a Schedule I substance under the federal Controlled Substances Act to a Schedule III substance. The DEA hearing on the matter, originally scheduled for December 2, was recently pushed into early 2025. The consequences of the rescheduling decisions could be enormous, and there is no shortage of high-powered, well-heeled organizations expressing their opinions on the matter.

Third, Congress is due to pass a new Farm Bill. We predict that will occur after Trump is inaugurated and there is a Republican-controlled Senate. Although early proposals in House committees would have broadly outlawed non-industrial hemp, more recent proposals from (an albeit Democratic- controlled Senate) have pointed towards a policy of more closely regulating but not banning most hemp products. We recently put forth our own framework for how the marijuana and hemp industries can both win in the next Farm Bill, as we’re still hopeful legislators will consider that reasoned compromise.

Whenever there is a momentous change in the halls of government, there is the potential for momentous policy changes. That is certainly a possibility under the present circumstances, but if we were gambling persons (we are) we would bet that marijuana is rescheduled, that federal agencies continue a largely hands-off approach to enforcing state-legal marijuana programs, and that the Farm Bill allows for the continuation of a hemp program that includes certain products that produce psychoactive effects.

Stay tuned. We’re all over this.

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Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a straight line.

As we previously reported, Lykos Therapeutics Inc. sponsored a new drug application for MDMA therapy. That application proposed a new protocol for the treatment of PTSD that combined the dosing of MDMA with multiple sessions of psychotherapy.  In support of its efforts, Lykos cites the backdrop of the “PTSD crisis” and the limited options for effective treatment.

There were reasons to be positive about Lykos’ application. As reported by Yahoo Finance:

Per the results of its phase 3 clinical trials published in the highly influential Nature Medicine Journal, Lykos’ approach helped patients to report fewer symptoms and thereby score lower on a few structured questionnaires that are designed to assess the severity of different aspects of PTSD. The cohort of the study that received only a placebo and psychological support did not experience anywhere near as many positive changes. Safety signals were as expected and as described in earlier-stage trials, with most side effects being mild and transient in nature. 

In other words, on the basis of the data Lykos published, its therapy looks like tis more than merely promising. It’s nearly as close to being proven as a candidate can get before it gets approved for sale by the FDA.

Earlier this month, however, on June 4, the Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted against the approval of MDMA-assisted therapy for the treatment of PTSD. The Advisory Committee concluded by a 9-2 vote that the data available did not show the proposed drug treatment was effective for patients with PTSD. The nine committee members voting against the drug application criticized the study for having expectation and selection biases, lack of diversity in the sample set, and potential result manipulation. In a 10-1 vote, the Advisory Committee also said there were too many gaps in the data to be able to determine that the benefit of MDMA outweighed the potential risk of using it in treatment, voting no on that question.

Dr. Walter Dunn, assistant clinical director at UCLA’s Department of Psychiatry, cast the lone “yes” vote on the question of whether the benefits of MDMA outweighed the potential risk of using it in treatment. He stated:

As has been stated before, we are in dire need of new treatments for PTSD… This has the potential to make a difference. Now, that’s not without its risks. But as I like to tell all my trainees, there’s no room for free lunch in medicine. And what has the potential for benefit has the potential for harm.”

As Lykos sees it, there are a few key issues raised by the Advisory Committee:

  • Evidence of effectiveness
  • Functional unblinding
  • Prior MDMA use of the study population
  • Psychological intervention in the research protocol and its regulation
  • Cardiovascular and hepatotoxicity risks
  • Sponsor and investigation bias

While each of these issues is something that Lykos (and possibly others seeking approval) will have to overcome to obtain FDA approval, we anticipate that functional unblinding is a challenge that the larger psychedelic industry will have to grapple with if it wants its drugs legalized.  As Lykos concedes, functional unblinding is a “known research challenge for psychiatric drugs with psychoactive effects.” Researchers and applicants are going to need to find solutions to this challenge to be successful.

The stock market certainly saw this as a setback. After the ruling, shares of psychedelics companies such as Compass Pathways, Atai Life Sciences, and Mind Medicine saw a steep drop. Many of those stocks remain down.

To be clear, this is not the final decision. The final decision rests with the FDA. We’ll be on the look out to see what happens later this summer, with an expectation that the FDA will issue a regulatory decision on the application in mid-August.

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It’s been, like, a whole year since our last 420 blog post, man. And the past year made way for even more of the choicest blog posts about cannabis industry topics ranging from the business of THC, CBD, the Deltas, Medical Marijuana, hemp, and more. Our second annual “Weed Roundup” — featuring our top 10 most read blog posts of the past 12 months — is packed with a hybrid of state and federal law updates, regulatory and compliance legislation, and predictions for what is to come in the cannabis industry. As the industry continues to blaze its own trail state by state, our team of authors has been buzzing to keep the freshest content delivered to you on the stickiest developments. Catch up on what you may have missed with the Budding Trends’ Top 10 Weed Roundup, and for everyone going to the Sphere this weekend, take care of your shoes!

This Will Be Our Year, Took a Long Time to Come: Will 2024 Be the Year for Marijuana Legalization in North Carolina?

By Nathan P. Viebrock & Whitt Steineker

Once hailed by observers as the southern state most likely to legalize marijuana first, North Carolina has not kept pace with its northern neighbors in adopting laws to promote the growth of a vibrant medicinal and personal-use marijuana industry. While 2023 saw a number of bills introduced in the House and Senate that touched on the legalization and regulation of hemp, medicinal and adult personal usage, last month the North Carolina General Assembly adjourned for the year with no bills having passed, leaving open a number of questions regarding the future of cannabis in the Tar Heel State. Let’s use this as a moment to reflect on where things stand in North Carolina and what’s on the horizon for 2024. Continue reading…

Big Tobacco Bets Big On Cannabis

By Slates C. Veazey

Word began circulating a few days ago that tobacco giant Philip Morris has agreed to purchase Israeli cannabis company Syqe Medical for a whopping $650 million if certain future events come to fruition.  While the two companies evidently have some history together, this new deal is reportedly tied to Philip Morris’ interest in acquiring Syqe’s metered-dose, pharmaceutical-grade inhaler that dispenses precise doses of medical cannabis to patients. Continue reading…

Will the Tennessee Legislature Continue to Leave Cannabis to Outlaw Country Music in 2023?

By J. Hunter Robinson & Savannah Kolodziej

Cannabis has long been a source of inspiration for musicians like Willie Nelson and Hank Williams Jr. Outlaws like Willie and Hank paved the way for the next generation of country artists to sing their cannabis praises. Margo Price has openly discussed the benefits of cannabis and released her own line of products containing the hemp-based, non-psychoactive cannabinoid CBG. Continue reading…

Mississippi Department of Health Revises Medical Cannabis Regulations: Feels Like I’ve Been Here Before

By Slates C. Veazey

I sound like a broken record, but I will say it again: To remain compliant in the cannabis industry requires an almost constant state of diligence. This point was reinforced earlier this month when the Mississippi Department of Health (MDOH) released a set of revised medical cannabis regulations. While many of the changes follow what the MDOH proposed last December, several are new.  One such new rule involves the standard symbol that must be placed on edible cannabis product labeling and packaging, effective July 1, 2023.  And, as proposed last December, the maximum quantity of usable medical cannabis that medical cannabis establishments can amass for testing as a “batch” has increased from 10 pounds to 25 pounds.  Further, the testing regulations received perhaps the most significant set of amendments. Continue reading…

Good News, Bad News: Congress Wants to Help the Hemp Industry

By Whitt Steineker

Last week in a small hearing room in a House office building, the House Oversight and Accountability Subcommittee on Health Care and Financial Services held a hearing titled “Hemp in the Modern World: The Years long Wait for FDA Action.” The hearing, billed as a “first-of-its-kind,” allowed lawmakers and hemp industry experts to discuss issues facing the industry today and in the future, and it was an important step in framing the debate about the next Farm Bill (the current Farm Bill expires September 30). In that sense, the hearing was a success. But a close examination of the testimony, the opening statements of the legislators, and the staggering distance between the parties on the appropriate policy solutions was sobering to this author. The main takeaway: The next Farm Bill will determine the future of the hemp industry in America. Continue reading…

Fifth Circuit Upholds Marijuana User’s Second Amendment Rights – Will the Eleventh Circuit Do the Same?

By Slates C. Veazey & Connor M. Blair

A question frequently encountered in the cannabis industry involves a cannabis user’s gun rights. This stems from the ever-present federal and state law tension overlaying marijuana in the United States — thanks to the Schedule 1 status of “marihuana” under the Controlled Substances Act. A Westlaw search quickly reveals that over the past year federal courts across the country have reached varying decisions on this or similar issues. For instance, courts in Texas and Oklahoma have held that, under certain circumstances, the Second Amendment protects marijuana users’ right to own and purchase firearms, while courts in Alabama and Mississippi have held the opposite. Continue reading…

To Reschedule or To Deschedule: That Is the (Marijuana) Question

By Whitt Steineker & Slates C. Veazey

Now that the dust is starting to settle on the recent news that the U.S. Department of Health and Human Services (HHS) has recommended to the U.S. Drug Enforcement Agency (DEA) that marijuana be moved from Schedule I to Schedule III under federal law, it is important to understand the implications of rescheduling marijuana and whether descheduling marijuana would be a preferred course. Continue reading…

Veep Urges DEA to Reschedule Marijuana “As Quickly as Possible”

By Whitt Steineker

In case you missed it, Fat Joe visited the White House late last week to discuss federal marijuana policy. 2024, man.

During a roundtable discussion with Mr. Joe (?), Kentucky Gov. Andy Beshear, and several individuals who have received pardons from President Joe Biden for prior federal marijuana convictions, Vice President Kamala Harris “urged the Drug Enforcement Administration to work as quickly as possible on its review of whether to reschedule marijuana as a less-dangerous drug.” Continue reading…

Will Mississippi’s List of Qualifying Conditions for Medical Cannabis Soon Be Expanded?

By Slates C. Veazey

Pursuant to the Mississippi Medical Cannabis Act, Mississippi residents can petition the state’s Department of Health to add new serious medical conditions or their treatments to the existing list of conditions that qualify a prospective patient for a medical marijuana card (Miss. Code Ann. § 41-137-17). Exercising this authority, the DOH recently made it easier for Mississippi residents to petition the agency to add conditions to that list, which currently includes the following conditions and treatments. Continue reading…

The Great Divide: The Feds’ Differing Approach to Psychedelics and Cannabis

By Hillary Campbell & Whitt Steineker

Just as we did, the Food and Drug Administration has recognized the growing enthusiasm for exploring opportunities to use psychedelic medications to treat mental health disorders. In June, FDA issued for the first time draft guidance providing considerations for those developing psychedelic drugs for the treatment of medical conditions. The guidance explicitly focuses on “classic psychedelics,” which are “typically understood” as “5-HT2 agonists” like psilocybin and LSD, as well as entactogens or empathogens like MDMA. Has this put a wedge between psychedelics and cannabis? Continue reading…

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If you know either of us, you know neither of us would pass up a chance to say, “I told you so.” As we looked ahead to 2024 in January, we speculated that psychedelics could be legalized as a prescription medicine. Now, not even a quarter into 2024, proponents of the psychedelic industry should be more optimistic that federal legalization of psychedelics as medicine is closer than ever.

MM120 is Mind Medicine Inc.’s proprietary, pharmacologically optimized form of LSD, which MindMed is developing for generalized anxiety disorder and other brain-based disorders. This month, FDA granted breakthrough therapy designation to the LSD-like substance MM120 for the treatment of generalized anxiety disorder. A breakthrough therapy designation is “designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

MindMed’s study showed that “a single oral dose of MM120…led to clinically and statistically significant reductions in anxiety scores 12 weeks after administration, with 65 percent of participants showing a clinical response and 48 percent in clinical remission following the treatment.” Clearly excited by the possibilities of the study’s conclusions and its approval, MindMed recently stated: “[t]he FDA’s decision to designate MM120 as a breakthrough therapy for [Generalized Anxiety Disorder] and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with [Generalized Anxiety Disorder]…We are committed to bringing MM120 to people living with [Generalized Anxiety Disorder] and delivering on the potential of our pipeline to treat serious brain health disorders.”

A notable aspect of MindMed’s study and use of MM120 is that it was not coupled with a therapy component. The trials did not include any therapeutic intervention such as talk therapy or psychotherapy. This stands in contrast to many other studies involving psychedelics that incorporate therapy as a component. If granted full approval, the absence of any therapy component may make the drug’s use even more appealing to a broader base of the general public.

Unsurprisingly, industry advocates see this as a very positive first step forward and a potential turning point for the psychedelic sector. FDA approval would almost certainly boost public perception and help to shed the stigma surrounding the industry.  

So, what’s next? MindMed is likely to meet with the FDA shortly and will also start Phase 3 of its trial this year. MindMed will also be busy at the private level. We expect the study’s data analysis to be presented at the American Psychiatric Association’s annual meeting in May and to be published in a leading medical journal. If the FDA ultimately approves the new drug application, DEA would need to reschedule MDMA accordingly. Currently, psilocybin, LSD, and MDMA are classified as Schedule I drugs by DEA. 

This will be seen as a big step forward for the fruiting psychedelics industry. This move by the FDA could be seen as an acknowledgement that psychedelics have the real potential to treat disorders that physicians up until this point haven’t been successful in finding ways to treat. It certainly bolsters our belief that the path forward for legalization of psychedelics will be paved by innovators in the pharmaceutical industry.

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A few weeks ago, the Ninth Circuit Court of Appeals in  Aggarwal v. U.S. DEA directed the U.S. Drug Enforcement Agency (DEA) to reconsider its decision not to transfer psilocybin from Schedule I to Schedule II. 

Since at least 2021, Dr. Sunil Aggarwal has been working to legally obtain psilocybin for terminally ill cancer patients undergoing end-of-life care.  Because psilocybin is a Schedule I drug under the Controlled Substance Act (CSA), obtaining the drug to treat his patients was “practically and legally difficult” according to his lawyers. Aggarwal turned to the DEA, petitioning the agency to transfer psilocybin from Schedule I to Schedule II. The DEA denied the petition in a four-sentence letter. Aggarwal then looked to the Ninth Circuit. 

The Ninth Circuit sided with Aggarwal, at least for now and at least in part. The court held that the “DEA failed to provide sufficient analysis to allow its path to be reasonably discerned” and “failed to clearly indicate that it ha[d] considered the potential problem identified in the petition.” More specifically, the Ninth Circuit noted that the DEA failed to define “currently accepted medical use with severe restrictions,” which was the applicable standard for rescheduling on which Aggarwal relied. The court directed the DEA to clarify or reevaluate its position.  

So, what does this mean?

Rescheduling Psilocybin

The Ninth Circuit’s opinion does not change the legal status of psilocybin.  Hope springs eternal, and the psychedelic industry may take this as a nod from the Ninth Circuit that psilocybin is on the fast track to being rescheduled. But the limitations of the court’s decision can’t be dismissed.  The Ninth Circuit’s order did not tell the DEA what decision to reach. And the chance for the DEA to reconsider (and rewrite) its determination could certainly result in a more robust denial from the DEA – one that would be more defensible by critics of rescheduling.

It, however, certainly keeps the petition to reschedule alive. So, yes, we’re telling you there’s a chance.

Given that our modest blog began as an update exclusively on the cannabis plant, we would be remiss not to direct you to our posts on recent efforts by the Biden administration to consider the rescheduling or de-scheduling of cannabis. If the psychedelic industry can learn anything from the cannabis industry, it’s that the implications of rescheduling could be huge but that the trip can be long.

The DEA’s Five-Part Test – Will It Hold Up?

Since the 90s, the DEA has utilized a five-part test for determining whether a drug has a “currently accepted medical use” and should be rescheduled pursuant to 21 U.S.C. § 812(b)(2)(B). Under the test, a drug is considered to have a “currently acceptable medical use” if it meets five elements:

  1. The drug’s chemistry is known and reproducible;
  2. There are adequate safety studies;
  3. There are adequate and well-controlled studies proving efficacy;
  4. The drug is accepted by qualified experts; and
  5. The scientific evidence is widely available.

(Though it would be fair of you to do so, Budding Trends readers shouldn’t confuse the DEA’s five-part test with the eight-part test utilized by the U.S. Department of Health and Human Services (HHS)). 

One could infer from the DEA’s denial letter that its position is that a drug must meet the five-part test to be rescheduled, but as noted by the Ninth Circuit, the DEA didn’t explicitly say so. And the DEA’s position on that remains to be seen.

The Ninth Circuit in Aggarwal made clear that it was not deciding whether the DEA’s five-part test is a lawful interpretation of 21 U.S.C.  812(b)(2)(B).  We expect that proponents of change will challenge the test in the coming months and years, and the Ninth Circuit’s decision seems to invite new challengers to do so.

Whose Line Is It Anyway? DEA Points to the FDA; Court Points Back to the DEA

Maybe the DEA is sick of always being the one to break up the party. The one thing that was abundantly clear in the DEA’s denial of Aggarwal’s petition was that the DEA was pointing the finger at the FDA. Specifically, the DEA’s position was that a prerequisite to transferring a substance from Schedule I to Schedule II “is for the [FDA] to determine that a substance has a currently accepted medical use in treatment in the United States.”  The Ninth Circuit wasn’t convinced and certainly didn’t bite at the chance to let the DEA shift the blame or the burden. The Ninth Circuit made it clear that the DEA cannot defer to the FDA and its lack of movement. The court’s decision said the DEA’s reasoning was contrary to 21 U.S.C. § 812(b)(2)(B), “which sets as a prerequisite to transfer to schedule II either a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.” 

In other words, absent movement by the FDA to determine that psilocybin has a “currently accepted medical use in treatment in the United States,” the DEA is going to have to make its own decision. It’s going to have to consider and assess whether psilocybin has a “currently accepted use with severe restrictions.” This is a distinct question from what the FDA may answer – whether psilocybin has “a currently accepted medical use in treatment in the United States.”

What’s Next?

Research regarding the medicinal use of psilocybin — and other psychedelics — is on the rise. And many studies seem to be seeing positive results for the industry.   

On at least two occasions in recent years, the FDA has designated psilocybin therapy as a “breakthrough therapy.” According to the FDA, a designation of a drug as “breakthrough therapy” is “designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.”

Results from a study recently published by Johns Hopkins and Ohio State “support the potential for psilocybin to produce lasting improvements in mental health symptoms and general wellbeing.” According to the study, its “results indicate broad therapeutic potential of psilocybin to produce lasting improvements in mental health symptoms related to anxiety, depression, and substance misuse.”

In another recent study led by “a research team from institutions including Yale, Johns Hopkins, NYU Langone, and San Francisco Veterans Affairs Medical Center and published in the Journal of the American Medical Association,” “outcomes reveal that psilocybin was well-tolerated and elicited fast, solid, and long lasting efficacy results” for treating adults with major depressive disorder.

Given what appear to be positive outcomes, we certainly expect there to be continued increases in funding into such studies – both from private and public sources. In the first part of this year, for example, the National Institute on Drug Abuse announced new funding opportunities for studies with a focus on the use of psychedelics to treat substance use disorders and allocated $1.5 million for such studies.

As more medical professionals come to believe there are serious medicinal benefits to the use of psychedelics like psilocybin, we think the pressure will only increase on the government to consider rescheduling.

*        *        *

The Ninth Circuit’s refusal to accept the DEA’s out-of-hand dismissal of a petition to reschedule psilocybin is yet another step in what appears to be faster and faster footsteps towards the future. What that future holds is yet to be determined – though we will monitor closely – but whatever the future is it promises to be quite a ride.

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Now that the dust is starting to settle on the recent news that the U.S. Department of Health and Human Services (HHS) has recommended to the U.S. Drug Enforcement Agency (DEA) that marijuana be moved from Schedule I to Schedule III under federal law, it is important to understand the implications of rescheduling marijuana and whether descheduling marijuana would be a preferred course.

When Budding Trends’ editors first wrote about the topic, we described it as a largely political announcement, rather than a fundamental change in policy from an administration that has never truly championed marijuana reform (something we also predicted before the 2020 presidential election).

I’m not too proud to say I was wrong, and I’m not yet sure if I was. Because let’s be clear: Federal law did not change with the recommendation from HHS. There are a number of hurdles and headwinds standing between that recommendation and a change in the scheduling of marijuana. Just for example, DEA must accept the recommendation and there are treaty obligations impacted by any rescheduling of marijuana. Oh, and if a Republican wins the White House before this gets done, look out. As monumental as the HHS recommendation and recognition that marijuana has medicinal value may be, it is far from certain.

But the point of this post is not to predict whether marijuana will be rescheduled; rather, I want to discuss whether it would be better policy to reschedule or deschedule marijuana.

The Legal Distinctions Between Descheduling and Rescheduling

The consequences between descheduling marijuana and rescheduling are enormous, both legally and practically.

Let’s first discuss the framework of rescheduling marijuana. The rescheduling process is an inter-agency governmental process that normally takes years and is rife with all of the bureaucracy and intra-agency infighting and inter-agency turf battles often associated with the federal government.

In the case of rescheduling a controlled substance under the Controlled Substances Act, HHS was tasked with overseeing a medical and scientific analysis of marijuana. The department coordinated this review with the U.S. Food and Drug Administration (FDA), which considered eight factors before making a control status recommendation.

According to federal statute, these eight factors include:

  1. Its actual or relative potential for abuse;
  2. Scientific evidence of its pharmacological effect, if known;
  3. The state of current scientific knowledge regarding drug and other substances;
  4. Its history of current pattern of abuse;
  5. The scope, duration and significance of abuse;
  6. What, if any, risk there is to the public health;
  7. Its psychic or physiological dependence liability; and
  8. Whether the substance is an immediate precursor of a substance already controlled.

Once HHS makes a rescheduling recommendation, the DEA is responsible for coming up with a final decision as to whether the substance should be rescheduled.

Although the letter from HHS recommending the rescheduling has not yet been released to the public, most observers believe that HHS is recommending that marijuana be moved to Schedule III.

Banking Marijuana Businesses

It’s not entirely certain how rescheduling marijuana would affect marijuana banking, and likely the effects would depend to some degree on whether marijuana products were compliant with Schedule III regulations. Some have expressed skepticism that a move to Schedule III would open the doors of banks to marijuana operators: 

But Vince Sliwoski, an attorney with Harris Bricken, said rescheduling won’t immediately change how cannabis firms do business or expand the universe of banking partners they can choose from. 

“At Schedule III, marijuana would still be a controlled substance and state-licensed businesses would still be ‘trafficking’ in a controlled substance, contrary to federal law,” he wrote in a recent piece. “The analysis for financial institutions won’t fundamentally change.”

In any event, congressional lawmakers could still take up the SAFE Banking Act later this year, and the rescheduling development would likely be a topic of discussion. SAFE, if passed, would exempt financial institutions from liability and penalties for working with marijuana businesses acting in accordance with state law, regardless of whether they serve medical patients or all adults.

280E and the Taxman

One of the most significant impediments to the growth of marijuana operators, and dispensaries in particular, is 26 U.S.C 280E. That one-sentence provision may be the biggest hurdle to the development of the marijuana industry in the United States. It dictates that:

No deduction or credit shall be allowed for any amount paid or incurred during the taxable year in carrying on any trade or business if such trade or business (or the activities which comprise such trade or business) consists of trafficking in controlled substances (within the meaning of schedule I and II of the Controlled Substances Act) which is prohibited by Federal law or the law of any State in which such trade or business is conducted.

280E has crippled the marijuana industry, often exacting an effective tax rate north of 60% for operators. “Within the meaning of schedule I and II of the Controlled Substances Act” is the ballgame. If marijuana is rescheduled to Schedule III, 280E would no longer apply and marijuana operations would be taxed as normal businesses – provided that Congress did not specially enact a marijuana tax.

Obviously, state tax laws may still penalize marijuana businesses akin to 280E, but some states proactively exempted licensed cannabis businesses from those impacts – like Mississippi.

Does Rescheduling Make Existing Marijuana Operations Legal?

One question that I have been asked dozens of times since the announcement of the potential rescheduling is whether rescheduling would make marijuana businesses legal under federal law. When it comes to adult use, the answer is an emphatic no. “Schedule III substances—which include ketamine, anabolic steroids and Tylenol with codeine—are still highly regulated and not permitted to be sold without a DEA license or used by consumers without a doctor’s prescription or other authorization.” When it comes to medical use, the answer is much hazier. “[M]ost states would need to overhaul their systems in order to strictly align with Schedule III restrictions.” Existing laws are a hodgepodge of rules and regulations that often do not meet the strident restrictions of the Controlled Substances Act. This would take time but, if successful, it would bring state and federal marijuana into alignment.

International Treaties

One element of DEA’s analysis will be how a Schedule III decision would play under international drug treaties.

It’s a step that might sound tedious for a country that helped put those prohibition-era agreements in place, but experts acknowledge it’s a possible bottleneck the plan would need to get through in order for HHS’s recommendation to become reality. It also has some past precedent: DEA asserted in its 2016 denial of a marijuana rescheduling petition that “in view of United States obligations under international drug control treaties, marijuana cannot be placed in a schedule less restrictive than schedule II.”

“I think it’s certainly possible and something that the industry needs to be very concerned about happening… In fact, they incorporate flexibility, so that countries like the United States can develop regulatory structures and compliance with activities that promote public health and welfare.”

It is worth noting that Canada has not yet faced sanctions under international treaty law when it legalized marijuana at the federal level in 2017.

The Practical Distinctions Between Descheduling and Rescheduling

Most current marijuana operators would strongly prefer that marijuana be descheduled as opposed to rescheduled. If marijuana was descheduled, those operators likely would be allowed to operate largely as they currently operate and in a scheme resembling that of alcohol regulation. The rules would be primarily a function of existing state laws, and presumably interstate commerce in marijuana would be legal for the first time in half a century. Also, the federal oversight that would likely exist in a new descheduled marijuana industry could bring a welcomed dose of uniformity and certainty across the country for things like advertising limits, labeling, testing requirements, and how food-related products are regulated. Maybe.

Big Pharma

As noted above, if marijuana is rescheduled such that it remains a controlled substance, marijuana companies may have to comply with much more stringent FDA rules, and physicians may still face the question of whether they are permitted to prescribe marijuana or certify patients as being eligible to use marijuana in a medical program. Given the cost of FDA compliance and the attendant costs for research, development, and testing, existing marijuana operators may find themselves priced out of the market (or find themselves as attractive candidates in the marijuana license sales market). If marijuana was listed as a Schedule III substance, it may be that marijuana will be brought to consumers courtesy of Big Pharma. Just imagine Kush Kontrol, brought to you by your friends at AstraZeneca! I can only imagine the commercials airing on primetime TV (snowboarding events seem like good opportunities).

Big Pharma’s influence over the marijuana industry, depending on who you ask, would have its pros and cons. On the upside, large pharmaceutical companies have the resources to conduct sophisticated clinical trials and develop products that are required to be safe and effective for consumers.  On the other hand – and this is the bad news for existing marijuana operators – placing the marijuana industry in the hands of pharmaceutical companies runs counter to how the industry developed and would pose a serious threat to the survival of many existing marijuana operators.

Relationship to Alcohol

Big Pharma won’t be the only major player in a descheduled or rescheduled marijuana industry. Recently, the Wine & Spirits Wholesalers of America (WSWA) released a public statement proclaiming that “the time has come for Congress to comprehensively legalize and regulate adult-use cannabis at the federal level.” In its memo, the WSWA makes the case for federal legalization and regulation by discussing what it dubs as the “Four Principles of Safe and Responsible Adult-use Cannabis Regulation.” Those four principles are:

  1. The permitting of marijuana producers, importers, testing facilities, and distributors;
  2. The approval and regulation of marijuana products;
  3. The efficient and effective collection of federal excise tax; and
  4. Effective measures to ensure public safety.

While the WSWA’s paper references a “shared state-federal regulatory structure,” its proposed model places much more of the regulatory oversight of a federally legal marijuana industry in the hands of the federal government over individual states.

And, as we discussed in a recent post, Anheuser-Busch and Tilray Brands Inc., a Canadian cannabis and consumer packaged goods company, announced Tilray’s acquisition of eight Anheuser-Busch beer and beverage brands the first week of August. Rest assured, the alcohol (and tobacco) industry is poised to jump head first into the cannabis world – especially if rescheduling occurs.

FDA Control

Others have expressed concern that a relaxation of marijuana’s controlled status could actually inadvertently upend the marijuana industry by potentially incentivizing and emboldening FDA to assume a more hands-on role with respect to marijuana, despite its largely laissez faire approach to hemp products.

If, for example, FDA is required to begin exercising the type of oversight over marijuana that it performs over existing manufacturers of controlled substances, marijuana operators are likely to face far closer scrutiny than they faced under any state regulation and be subject to far more significant operating costs than they already experience.

Advertising

A less obvious result of rescheduling is that advertisements in newspapers, magazines and other media could also more easily travel across state lines:

While not common, USPS has in the past issued warnings about marijuana mailings, noting in a 2015 letter to a congressman that the CSA prohibits placing in “any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule I controlled substance” as well as using U.S. mail to facilitate “the commission of any act or acts constituting a felony.” At least one newspaper subsequently pulled marijuana ads in response to a warning it received.

If marijuana were moved into Schedule III, the obstacle to mailing marijuana advertisements would disappear. (Sending actual marijuana through the mail, of course, would still be subject to tight Schedule III restrictions.)

Others have noted the impact of rescheduling on federal employees and contractors, and the distinction may prove a difference:

[T]he use of Schedule I and Schedule II drugs by federal government workers is prohibited under a 1986 executive order from then-President Ronald Reagan that established the Federal Drug-Free Workplace program. While individual agencies have adopted their own policies regarding drug use, many are rooted in the Reagan order. Because that order defines “illegal drugs” as only those in Schedules I and II, some attorneys believe rescheduling to Schedule III could lift marijuana restrictions that currently apply to all federal workers.

Other legal experts weren’t so sure. Shane Pennington, a partner at the law firm Porter Wright Morris & Arthur, cautioned that “various agencies have their own internal policies that would not necessarily change automatically as the result of cannabis being transferred to [S]chedule III.”

People who work as third-party federal contractors or grantees, however, would likely not see a policy shift as the result of rescheduling. Under federal law governing public contracts, contractors may not possess or use a “controlled substance,” defined as any drug “in schedules I through V” of the CSA.

Marijuana Research

Rescheduling would also mean sweeping changes for marijuana research, removing many of the barriers to obtaining and using marijuana for scientific investigation. A key Senate committee recently noted that the drug’s Schedule I designation means scientists face “limited access to sources” of marijuana, further hobbling research. Of course, the newish Marijuana and Cannabidiol Research Expansion Act has its own provisions and requirements specific to marijuana research that must be complied with – separate and apart from other federal statutes applicable to federal marijuana research.

Schedule III rules would also still stand in the way of researchers trying to study the marijuana available on licensed, adult-use retail markets in legal states.

Existing State Marijuana Laws

DEA putting marijuana into Schedule III of the federal CSA could nevertheless trigger changes in some state laws. That’s because, in some cases, state laws themselves follow the federal CSA.

Essentially, some states have triggering laws that make the state’s scheduling correspond with a schedule change automatically, and then others don’t… So it requires a 50-state analysis of which states do it automatically and then making sure that’s implemented. And then for states that don’t, that legislative and administrative process usually has to happen.

In other words, federal rescheduling would likely spark a cascade of changes at the state level, most related to medical marijuana.

The Political Implications of Rescheduling vs. Descheduling

Aside from the array of formal changes that rescheduling would bring about, it could also embolden lawmakers at the state and federal levels to push for further marijuana reforms. With the federal government formally acknowledging that marijuana has medical benefits and is no longer among the class of the most dangerous drugs, the move could lessen stigma toward marijuana use, especially for medical purposes.

The HHS rescheduling memo is momentous largely because, as Hauser pointed out, it represents the U.S. government recognizing that marijuana, contrary to the definition of a Schedule I substance, has “currently accepted medical use.” Though the acknowledgment comes years or decades after many patients, voters and even elected officials arrived at the same conclusion, it’s nevertheless a historic milestone. But it’s also worth keeping in perspective: The HHS recommendation on its face says essentially that marijuana ought to be classified alongside substances like ketamine and testosterone.

Oh, Marijuana Stocks Are Poppin’

Perhaps to the surprise of no one, marijuana stocks skyrocketed on the news of the potential rescheduling. These stocks, which have suffered declines of between 30% to 80% in the past couple of years, are up double digits in the past few weeks and appear ready to go even higher on the expectation that DEA will follow the lead of HHS. Picking stocks is beyond the purview of the Budding Trends blog, but the influx of money into marijuana companies offers – at least in the short term – huge potential for growth in the industry.

Conclusion

When I first wrote about the potential rescheduling of marijuana, my conclusion at that time was that “[t]here does not appear to be an appetite in Congress or in the White House to change the legal status of marijuana.” I also noted that if I was wrong, “the consequences of any change will be hugely consequential.” As I write this, I stand by both predictions. But the HHS recommendation has rightfully caused marijuana observers to at least consider the (slightly paraphrased) words of The Bard:

To reschedule or to deschedule: that is the question.

Whether ’tis nobler in the mind to suffer

The slings and arrows of outrageous fortune,

Or to take arms against a sea of troubles,

And by opposing end them?

Oh yes, Budding Trends is out here quoting Hamlet.

Listen to this post

We’ve been tossing this idea around in our heads ever since research about microdosing psychedelics entered the mainstream media a few years ago. And the more we think about it, the more we think Congress may allow patient access to psychedelic treatments before it does so for marijuana.

Before you think we’ve been consuming too much of either product, consider this: It now appears that a bipartisan majority of the House of Representatives will pass legislation directing the secretary of defense to conduct a clinical study in military treatment facilities using psychedelics. This is an extraordinary development that could revolutionize medical treatments and will certainly draw strong opposition from those who worry that the government is too quick to legalize products once viewed as taboo.

Wait, What?

You heard that right. Congress appears to be moving more quickly on allowing access to psychedelic medications than it does on medical cannabis. How did that happen?

As an initial matter, concern for mental health is at an all-time high. Patients and the medical community alike are looking for something new to treat a wide range of mental health conditions – ranging from addiction, anxiety, and PTSD to treatment-resistant depression. Couple this need with the increasing enthusiasm among funding sources (private and philanthropic) and researchers to learn more about the medical effects of psilocybin and other psychedelics, and a real opportunity exists to argue in favor of providing broader access.

Further, there is a perception that the research on the medical benefits has been more clinical in nature, whereas the research on cannabis has been more anecdotal. This may not be a fair characterization, and it largely ignores the difficulty in conducting cannabis research under current federal law. Nevertheless, the perception seems to be winning out in current policy debates.

Another subtle difference between the products is that, whereas cannabis is typically associated with a euphoric “high,” with proper dosing, psychedelics arguably do not create a euphoric effect. Instead, advocates of psychedelics position it more as a medicine that simply treats the underlying conditions and symptoms without the need for putting a patient in an obvious mind-altering state. Whether that is true of psychedelics or whether that is a fair characteristic of medical cannabis, it appears to be the tenor of current policy discussions regarding both products.

And here’s a difference that didn’t immediately jump to mind but may be important in swaying public opinion: Americans don’t smell psychedelics when they are being ingested on the street. Don’t underestimate the importance of the little things.

There is also a historical difference between cannabis and psychedelics. While both have been used by humans for centuries, perhaps there is less of a stigma with extremely low-dose psychedelic products than there is with cannabis. After all, cannabis has been closely (and often wrongly and unfairly) associated with certain types of people that become easy targets for lawmakers. In the 1930s, when the Marijuana Tax Act became law, the targets were immigrants, bohemians, and “jazz musicians,” with all of the connotations that came with that term at the time. It was also the victim of industrialists who viewed cannabis (hemp, in particular) as a threat to existing sources of products such as paper. In the 1970s, when the Controlled Substances Act became law, the target was largely inner-city residents and protestors of the Vietnam War.

Psychedelic substances, however, have been less prominent in popular culture and have largely escaped the attention of lawmakers. Proponents of psychedelics, therefore, have less of a stigma to overcome and are well-positioned to argue that the products are well-studied medications as opposed to looking for federal approval of a previously vilified substance.

Next Steps for Psychedelic Medications

Before we get ahead of ourselves, let’s level set. First, the language before the House is relatively modest. “The legislation does not legalize psychedelics or even make them readily available as medicines. It just makes the drugs a little easier to study, and easier to understand.” Second, it may face stronger opposition in the Senate. Even though the upper chamber is (narrowly) controlled by Democrats, it is generally viewed as more conservative on these types of issues. As just one example from the cannabis world, the House of Representatives passed the SAFE Banking Act (allowing financial institutions to bank cannabis proceeds in certain circumstances without implicated money laundering rules), and that legislation has yet to come to the Senate floor for a vote.

The next immediate hurdle for psychedelics is the Senate and then the White House, which may be forced to decide whether to sign such legislation in an election year. If the legislation becomes law, the next hurdle is expanding the use of psychedelics beyond clinical studies and the military. That is a big step, but it will seem a bit smaller if there is already legislation allowing for its use for certain purposes.

And for what it’s worth, lawmakers considering the proposal will learn that the federal government wouldn’t be alone if it allowed for the use of psychedelics. Australia recently announced it will permit the prescription of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression beginning July 1. And domestically, the states of Oregon and Colorado have already legalized the use of certain psychedelics.

Impact on Cannabis Reform Efforts

So, what, if anything, does this mean for long-standing and enduring efforts to reform cannabis policy at the federal level? We think it comes down to a simple question: Is this a rising tide phenomenon where psychedelics and cannabis can gain popular and political acceptance as medications, or is it a zero sum game where the success of one means the failure of the other (as the poet wrote, “maybe you’ve had too much too fast”)?

While it’s impossible to know for sure, we think the former is more likely. As the general public becomes more accepting of the use of these products as medicine and as the research on the medicinal benefits grows, we believe Congress is likely to take a less skeptical view of them.

That doesn’t mean the path will be easy for advocates of the products. After all, these developments are taking place against the backdrop of decades of legal and popular opposition. And there may be a desire for the proponents of cannabis to press for progress in that industry at the expense of the psychedelic industry, and vice versa.

Ultimately, however, we believe that if Congress begins to accept the notion that once-illegal products can provide medical benefits to Americans, that is a win for both industries.

Conclusion

Cannabis has long been considered by many to be a gateway drug to other illicit substances. But is it possible that Congress will recognize psychedelics before cannabis? It’s a close call, but we think it just may happen. Stay tuned for much more.

And if you feel like we’re already through the looking glass, we’ll close with a bit of Eastern philosophy on the subject from noted Zen monk and punk rock bassist Brad Warner:

Zen practice is about not getting high on anything and in so doing getting high on absolutely everything. We then find that everything we encounter – bliss or nonbliss – possesses a tremendous depth and beauty that we usually miss.