Search results for: psychedelic

Listen to this post

On August 11, 2025, the U.S. Drug Enforcement Administration officially transmitted a request to the Department of Health and Human Services to loosen the federal restriction on psilocybin, seeking to move one of the better-known psychedelics from Schedule I to Schedule II under the Controlled Substances Act. The petition was submitted by a familiar face to Budding Trends readers, Dr. Sunil Aggarwal. This marks a big step in Aggarwal’s years-long legal battle, which I’ve found myself keeping close tabs on.

One Step: Rescheduling Psilocybin

As a reminder, back when Aggarwal originally petitioned the DEA to reschedule psilocybin, “the DEA denied the petition.” On appeal, “[t]he Ninth Circuit Court of Appeals in Aggarwal v. U.S. DEA directed the [DEA] to reconsider its decision not to transfer psilocybin from Schedule I to Schedule II”.

Two Step: The Right to Try Act

Aggarwal also pursued a separate approach via the Right to Try Act. We explained those efforts here:

The DEA said no dice and clung tight to the CSA. In so doing, the DEA made a few things clear:

  • “Practitioners who seek to dispense or possess [S]chedule I controlled substances must be properly registered as an approved researcher in accordance with the CSA and its implementing regulations.”
  • The RTT Act does “not provide any exemptions from the CSA or its implementing regulations.”
  • The RTT Act does “not give the DEA authority to waive CSA requirements.”

Doubling down, the DEA also declined Aggarwal’s request to initiate rulemaking to exempt him from the CSA’s registration requirement. The DEA provided the following as its reasoning:

  • The DEA could not fully assess Aggarwal’s proposal because it was lacking in detail.
  • Aggarwal’s desire to administer psilocybin to patients was not consistent with public health and safety. In making this particular finding, the DEA relied heavily on Congress’ determinations in designating psilocybin as a Schedule I drug that it has a high potential for abuse, no currently accepted medicinal use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
  • Aggarwal’s cited historical scenarios involving Schedule I controlled substances — including marijuana — were not persuasive.

The Ninth Circuit found in favor of the DEA, ruling that the DEA’s reasoning in blocking Aggarwal’s access to the DEA was not arbitrary and capricious.  While the Ninth Circuit didn’t declare the following reasoning the rule of land even within the Ninth Circuit, it did make clear that the DEA’s reliance on this reasoning is not arbitrary and capricious:

  • “The CSA and FDCA together govern access to controlled substances for medicinal purpose.”
  • “Although the RTT Act itself does not require FDA approval for eligible patients to access eligible investigational drugs, it does not exempt such drugs from the FDA’s Attorney-General-delegated oversight pursuant to the CSA.” “So DEA’s continued enforcement of the CSA’s registration requirement does not affect, modify, repeal, or supersede the FDCA as amended by the RTT Act.”
  • The Ninth Circuit did not reject the DEA’s reliance on Congress’ determination, as codified in the CSA, that psilocybin has a high potential for abuse, no currently accepted medicinal use in treatment in the United States, and a lack of accepted safety for use under medical supervision.

Let Me See You One, Two Step

In what may feel like a one, two step dance of one step forward and two steps back, it seems Aggarwal may actually be making some progress now towards rescheduling.

In July, the DEA said that “it had the necessary material to seek a medical and scientific analysis and scheduling recommendation from HHS,” and has not sent over the petition to HHS. 

So, what happens next? The HHS evaluates Aggarwal’s petition and makes a recommendation to the DEA. The DEA will be bound by the HHS’s scientific findings but can undertake its own investigation into psilocybin’s safety risks. Lest we get ahead of ourselves, the determination of whether to submit a notice of proposed rulemaking to reschedule psilocybin lies with the DEA.

Aggarwal’s attorneys are optimistic, stating “[g]iven the Breakthrough Therapy designations previously granted psilocybin by FDA, as well as the abundant clinical trial results supporting rescheduling, HHS and FDA are in position to quickly provide DEA an evaluation and scheduling recommendation before sending the matter back to DEA to begin the formal rulemaking process required to reschedule.”

It remains to be seen how the DEA will weigh the positive clinical trials and studies and the FDA’s designation of psilocybin as a “breakthrough therapy” against potentially preconceived notions or evidence (depending on who you ask) that psilocybin poses some safety threat. Stay tuned and we’ll keep you up to date.

Listen to this post

As the hallowed cannabis holiday for stoners-turned-business-entrepreneurs falls upon us, we find ourselves in the shifting sands of change in the cannabis industry as usual. Not surprisingly, many states have seen legislation brought to the table, decisions made at the courts, and commentary presented by politicians that will directly impact cannabis businesses, medical marijuana dispensaries, hemp cultivators, and more. In our 2025 “Weed Roundup” of the top 10 most read Budding Trends blog posts, we visit North Carolina, California, Georgia, Alabama, Michigan, and federal marketplaces for updates (search our posts for updates from Mississippi, Tennessee, Colorado, Ohio, Arizona, Texas, South Carolina, Missouri, Kentucky, Virginia, among others). As we delve into each state’s unique legal journey in adapting or resisting new cannabis norms, trust our expert editors to provide you with the most comprehensive and timely analyses in the cannabis industry.

Don’t believe us? First, check out the editors’ Top Trends in 2024 and 2025 Predictions blog posts.

Now, to the countdown:

Does Kamala Harris Support Marijuana Legalization? Squaring Words with Actions in an Evolving Political Environment

As she did just prior to becoming the Democratic Party nominee for president, Vice President Kamala Harris has announced her support for legalizing adult-use marijuana use at the federal level. Just to remind you of the interesting times we are living in, the veep did so during a guest appearance on the sports podcast “All the Smoke.”

“I just think we have come to a point where we have to understand that we need to legalize it and stop criminalizing this behavior,” Harris said. Harris made a point to argue that her support of legalization was not new, saying that “I have felt for a long time we need to legalize it.”…read more.

Joint Effort: Why a New Crop of House Members, a New Speaker, and Continued Bipartisan Support Could Finally Light the Way for Medical Marijuana in N.C.

In November 2023, we pondered whether 2024 might be “the year” for medical marijuana legalization in North Carolina. Well, it wasn’t.

Why, you ask? How can a state whose population has expressed overwhelming bipartisan support for medical marijuana legalization still have nothing to show for it? How can a state whose Senate has shown overwhelming bipartisan support (see Senate Bill 3 and Senate Bill 711) for medical marijuana legalization still have nothing to show for it? …read more.

California Bans Most Hemp Products and Illuminates Battle Between Hemp and Marijuana Businesses

What if I told you that California of all places – where virtually any adult can purchase marijuana on demand – was trying to harsh the mellow of citizens trying to access certain hemp-derived products? On the next 30 for 30, “California Schemin’.”

Welcome to the next front of the battle between marijuana and hemp.

California Gov. Gavin Newsom recently announced “emergency” regulations that would ban products derived from industrial hemp that contain any intoxicating cannabinoids and set an minimum age of 21 years old to purchase hemp products… read more.

Georgia Legislature Considering Substantial Overhaul to Medical Marijuana, Hemp Laws

I’ve had Georgia on my mind these days. I needed to get that out immediately because otherwise I would have been hearing that song in my head the entire time I was writing.

As is the case in many capitals around the country during legislative sessions, there’s cannabis reform afoot in Georgia. Before we dig into it, perhaps a brief vocabulary lesson is in order. “Cannabis” is essentially a scientific term that refers to the cannabis plant. “Marijuana” and “hemp” are legal terms distinguishing between strains of the cannabis plant. At the federal level, for example, “hemp” has been defined as a strain of the cannabis plant containing less than 0.3% delta-9 THC on a dry weight basis… read more.

Trump Expresses Support for Marijuana Reform, Coy on Psychedelics

Cannabis consumers can be forgiven for feeling the need for a more liberal cannabis policy as they weather this seemingly unending campaign cycle.

Republican presidential candidate Donald Trump recently made clear how he would be voting personally on the legalization of the recreational use of marijuana. Posting on Truth Social, Trump stated:

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

Alabama Legislature Weighs Substantial Cannabis Reforms: Let’s All Take a Deep Breath

Well, it’s officially crazy season. An annual tradition in the Alabama statehouse since the inception of Alabama’s medical cannabis program, last week we saw a flurry of cannabis-related bills introduced with great fanfare and the accompanying panic amongst cannabis stakeholders in Alabama. I was inundated with a high volume of calls, texts, and emails unseen since the last Alabama legislative session.

And there was a little something for everyone involved in cannabis, both on the hemp and medical cannabis side. The good news? Things may be trending in the right direction… read more.

DEA Reschedules Rescheduling, and I’m Feeling a Little Like Charlie Brown Trying to Kick the Football

No, it’s not (just) a cruel play on words. Last week, the Drug Enforcement Administration announced that a much-anticipated public hearing on the proposal to reschedule marijuana would be moved from early December until the first quarter of 2025. I’m not sure I specifically predicted this, but it’s just about the most predictable thing ever. And it has a number of people thinking (wrongly in my opinion) that rescheduling may not even happen given the results of the recent elections… read more.

Michigan Court Prohibits Sale of Illegal Marijuana in a Ruling Straight Out of “Duh” Magazine

Believe it or not, I actually spend a lot of time deciding whether something is worth taking the time to write about. Cannabis news is developing as rapidly as any area of the law, and there are only so many hours in a day. I’ll admit up front that this was a close call.

There could be some angle that I’m not quite getting that would allow for unlicensed marijuana sales in states that have adopted marijuana licensing regimes, but I’m leaning towards thinking this may be one of the silliest, most obvious cases I’ve seen in years (and I see some wild cases in this line of work)… read more.

Federal Appeals Court: Pay That Man His Money, Unless That Money Is Illegal Marijuana Money

Good news, bad news if you’re a cannabis operator that owes money to a creditor. But probably bad news for the rule of law.

A federal appellate court has ruled that a cannabis operator is obligated to repay his debts to an ex-business partner, but it raised questions about whether the money used to repay the debt could violate federal marijuana laws.

What does this mean for a cannabis operator and potential investors? …read more.

How Will the Cannabis World Look When Marijuana Is Rescheduled?

A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a quote from “Run Like an Antelope” but then it hit me: Maybe we should give some thought to a more high-minded discussion about the practical implications of marijuana rescheduling. (Editor’s note: This exchange did not actually happen.) So, I guess set the gear shift for the high gear of your soul, and let’s dive in… read more.

Listen to this post

It’s funny how things work out – sometimes you find yourself living in a sort of butterfly effect where the tail seems to wag the dog. In 2023, when we first started writing about the traction psychedelics were gaining as medicine, our goal was not to end up spending years covering the winding legal battle of a Washington physician to legally obtain psilocybin for terminally ill cancer patients to manage their pain. 

But here we are. To be clear, while we’re certainly interested in the fate of Dr. Sunil Aggarwal’s efforts, we’ve been following the case closely because it’s one of a few legal cases to shed light onto what courts and federal agencies may do when faced with a medicinal demand for psychedelics outside of the research context.

In his efforts to be able to administer psilocybin to his patients, Aggarwal employed a two-fold approach: (1) he attacked the status of psilocybin as a Schedule I drug, and (2) he tried to get around statutory requirements governing a physician’s right to distribute Schedule I drugs outside of the research context. Neither has been successful (yet).

DEA Says No to Rescheduling, but the Court Keeps the Door Cracked

As a reminder, here’s what happened when Aggarwal petitioned the DEA to reschedule psilocybin:

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 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. 

The Ninth Circuit sided with Aggarwal. 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.

And, while the footsteps may not have been as swift as some would hope, we still stand by the predictions we made in 2023:

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.

Will the Right to Try Act Save Practitioners Who Don’t Conduct Research but Want to Administer Schedule I Drugs?

Perhaps realizing that convincing the DEA to reschedule psilocybin may be a tall task, Aggarwal tried his hand before the DEA and then the Ninth Circuit with another approach — trying to get around the Controlled Substance Act (CSA) by way of the Right to Try Act (RTT Act). Aggarwal challenged the DEA’s decision not to exempt him from registration under the CSA, but the FDA’s RTT Act didn’t turn out to be the rescuer he had hoped for.

Because it’s a Schedule I substance, the CSA dictates that psilocybin may only be produced, dispensed, or possessed in the context of a research protocol registered with the DEA and approved by the Secretary of Health and Human Services. In other words, psilocybin may only be dispensed by medical practitioners in the context of “bona fide research,” which requires the approval of the FDA (see21 U.S.C. § 823(g)(2)(A)). The DEA handles registration and “may, by regulation, waive the requirement for registration of certain…distributors, or dispensers if DEA finds it consistent with the public health and safety” (21 U.S.C. § 8222(d)).

The Food, Drug, and Cosmetic Act (FDCA) is even broader and “imposes restrictions on the…distribution of all drugs including but not limited to controlled substances” (21 U.S.C. § 331). Generally, before a new drug can be introduced to the market, it must go through the clinical trial process, but there are other ways. A patient, for instance, may attempt to access a new drug through the FDA’s expanded access program.

Where a prescription drug is a controlled substance, “the FDCA and CSA operate in tandem” and the person distributing the drug must comply with both statutes.

The FDA has also adopted the RTT Act, which is intended to expand access for eligible investigational drugs outside the clinical trail process. “The RTT Act exempts the drugs provided to eligible patients from specified statutory and regulatory requirements concerning drug labeling, marketing, clinical, testing and approval.” “To access an eligible investigational drug under the RTT Act,” an eligible patient’s physician applies directly to the drug’s sponsor, and the FDA is not involved in approving access.

Seeking psilocybin for his terminally ill patients, Aggarwal’s attorneys submitted a letter to the DEA asking the DEA “for authorization to access psilocybin for therapeutic use under state and federal RTT Acts and immunity from prosecution under the CSA.” His lawyers also asked that if it deemed registration was required under the CSA, that the registration requirement be waived.  

The DEA said no dice and clung tight to the CSA. In so doing, the DEA made a few things clear:

  • “Practitioners who seek to dispense or possess [S]chedule I controlled substances must be properly registered as an approved researcher in accordance with the CSA and its implementing regulations.”
  • The RTT Act does “not provide any exemptions from the CSA or its implementing regulations.”
  • The RTT Act does “not give the DEA authority to waive CSA requirements.”

Doubling down, the DEA also declined Aggarwal’s request to initiate rulemaking to exempt him from the CSA’s registration requirement. The DEA provided the following as its reasoning:

  • The DEA could not fully assess Aggarwal’s proposal because it was lacking in detail.
  • Aggarwal’s desire to administer psilocybin to patients was not consistent with public health and safety. In making this particular finding, the DEA relied heavily on Congress’ determinations in designating psilocybin as a Schedule I drug that it has a high potential for abuse, no currently accepted medicinal use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
  • Aggarwal’s cited historical scenarios involving Schedule I controlled substances — including marijuana — were not persuasive.

The Ninth Circuit found in favor of the DEA, ruling that the DEA’s reasoning in blocking Aggarwal’s access to the DEA was not arbitrary and capricious.  While the Ninth Circuit didn’t declare the following reasoning the rule of land even within the Ninth Circuit, it did make clear that the DEA’s reliance on this reasoning is not arbitrary and capricious:

  • “The CSA and FDCA together govern access to controlled substances for medicinal purpose.”
  • “Although the RTT Act itself does not require FDA approval for eligible patients to access eligible investigational drugs, it does not exempt such drugs from the FDA’s Attorney-General-delegated oversight pursuant to the CSA.” “So DEA’s continued enforcement of the CSA’s registration requirement does not affect, modify, repeal, or supersede the FDCA as amended by the RTT Act.”
  • The Ninth Circuit did not reject the DEA’s reliance on Congress’ determination, as codified in the CSA, that psilocybin has a high potential for abuse, no currently accepted medicinal use in treatment in the United States, and a lack of accepted safety for use under medical supervision.

So, What Does an Opinion Brushing Back One Physician on the West Coast Mean to the Psychedelics Industry More Broadly?

Proponents and physicians who are looking for easier access to psilocybin outside of the research context will see this as a significant step back. The DEA dealt a significant setback to the ability to rely on the RTT Act or to seek a waiver of registration. The Ninth Circuit didn’t really pull back the reigns. The DEA’s position that, even if a physician is able to obtain approval under the RTT, he or she still must obtain registration or a waiver under the CSA has now been approved (or at least not disapproved). And that position was pretty clear: The DEA is still in charge.

So, what does the opinion not mean? This opinion does not foreclose the efforts of physicians interested in conducting research blessed by the CSA and FDA. As we’ve previously reported, interest in researching psychedelics remains high and it appears capital does, too. Indeed, there are strong pushes for research in the federal, state, and private sectors with corresponding funding. There is no indication — and we have no expectation — that it will slow down any time soon, and the Ninth Circuit’s decision does nothing to change our thoughts on that point. Indeed, it appears to be, at least according to the DEA as approved by the Ninth Circuit, the clearest path forward.

Listen to this post

2024 was a banner year for cannabis lawmakers and business operators. From Kamala Harris advocating for marijuana reforms to California’s clash of titans between hemp and marijuana markets, there was no shortage of drama in the cannabis industry. Vice President Harris vocally championed marijuana legalization on various platforms, emphasizing its importance for social justice. Meanwhile, California’s hemp regulations sparked controversy in an already thriving marijuana market. Political figures and states continually reshaped the cannabis landscape. Even rapper Fat Joe met with the White House on cannabis reform… In this continually evolving industry, here’s a deep dive into the top 10 cannabis stories that made waves in 2024.

1. Does Kamala Harris Support Marijuana Legalization? Squaring Words with Actions in an Evolving Political Environment

Author: Whitt Steineker

As she did just prior to becoming the Democratic Party nominee for president, Vice President Kamala Harris has announced her support for legalizing adult-use marijuana use at the federal level. Just to remind you of the interesting times we are living in, the veep did so during a guest appearance on the sports podcast “All the Smoke.”

“I just think we have come to a point where we have to understand that we need to legalize it and stop criminalizing this behavior,” Harris said. Harris made a point to argue that her support of legalization was not new, saying that “I have felt for a long time we need to legalize it.”

I have no evidence or specific reason to believe that Harris doesn’t mean what she says, and her words should come as welcome news to advocates of adult-use marijuana. But as we consider the ferocity and motivation behind her position, I do think it’s worth noting (1) her reasons for supporting marijuana reform and (2) her prior statements and actions regarding marijuana. 

2. California Bans Most Hemp Products and Illuminates Battle Between Hemp and Marijuana Businesses

Author: Whitt Steineker

What if I told you that California of all places – where virtually any adult can purchase marijuana on demand – was trying to harsh the mellow of citizens trying to access certain hemp-derived products? On the next 30 for 30, “California Schemin’.”

Welcome to the next front of the battle between marijuana and hemp.

California Gov. Gavin Newsom recently announced “emergency” regulations that would ban products derived from industrial hemp that contain any intoxicating cannabinoids and set an minimum age of 21 years old to purchase hemp products.

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

Author: 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.”

The vice president, in direct terms, stated that it was “absurd” and “patently unfair” to keep the drug in the same highly restrictive tier as heroin and fentanyl. “Nobody should have to go to jail for smoking weed,” Harris said, according to NPR, framing the issue of marijuana reform as a criminal justice issue that disproportionately hurts Black and Latino men.

As to timing, Harris reportedly said: “I cannot emphasize enough that they need to get to it as quickly as possible, and we need to have a resolution based on their findings and their assessment.”

4. Trump Expresses Support for Marijuana Reform, Coy on Psychedelics

Authors: Hilary Campbell, Whitt Steineker

Cannabis consumers can be forgiven for feeling the need for a more liberal cannabis policy as they weather this seemingly unending campaign cycle.

Republican presidential candidate Donald Trump recently made clear how he would be voting personally on the legalization of the recreational use of marijuana. Posting on Truth Social, Trump stated:

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

Amendment 3 would allow “adults 21 years or older to possess, purchase, or use marijuana products and marijuana accessories for non-medical personal consumption.” It would also allow medical marijuana treatment centers, as well as other state licensed entities, to acquire, cultivate, process, manufacture, sell, and distribute such products and accessories. Amendment 3 would also establish possession limits for personal use – allowing possession of up to 3 ounces and up to an additional 5 grams of concentrate.

5. Will Hemp Save the World, Before the Government Kills It?

Author: Whitt Steineker

There is a great line in the wonderful film Charlie Wilson’s War, where Charlie Wilson (played remarkably by the inimitable Tom Hanks) describes the successful, if relatively covert, involvement of the United States government in the Soviet-Afghan War: “These things happened. They were glorious and they changed the world… and then we f***d up the endgame.”

With the next Farm Bill somewhere on the horizon, I believe we are approaching a similar moment for the future of hemp. I believe the future of hemp is glorious and that it can change the world. What will we do to the endgame?

This is an analysis about the current state of hemp and whether that industry will revolutionize the world before the government relegates it back to the ash heap of history. It just so happens to dovetail with my personal experience representing clients in connection with the hemp business.

6. Federal Appeals Court: Pay That Man His Money, Unless That Money Is Illegal Marijuana Money

Author: Whitt Steineker

Good news, bad news if you’re a cannabis operator that owes money to a creditor. But probably bad news for the rule of law.

A federal appellate court has ruled that a cannabis operator is obligated to repay his debts to an ex-business partner, but it raised questions about whether the money used to repay the debt could violate federal marijuana laws.

What does this mean for a cannabis operator and potential investors?

7. DEA Reschedules Rescheduling, and I’m Feeling a Little Like Charlie Brown Trying to Kick the Football

Author: Whitt Steineker

No, it’s not (just) a cruel play on words. Last week, the Drug Enforcement Administration announced that a much-anticipated public hearing on the proposal to reschedule marijuana would be moved from early December until the first quarter of 2025. I’m not sure I specifically predicted this, but it’s just about the most predictable thing ever. And it has a number of people thinking (wrongly in my opinion) that rescheduling may not even happen given the results of the recent elections.

Our friends at Marijuana Moment did a nice job laying out the facts:

After DEA Administrator Anne Millgram signed off on over two dozen witnesses to participate in the hearing on Monday, Chief Administrative Law Judge (ALJ) John Mulrooney issued a preliminary order on Thursday signaling that the information provided on those set to testify was insufficient and requesting additional details and potential availability for a formal hearing in January or February 2025.

8. Michigan Court Prohibits Sale of Illegal Marijuana in a Ruling Straight Out of “Duh” Magazine

Author: Whitt Steineker

Believe it or not, I actually spend a lot of time deciding whether something is worth taking the time to write about. Cannabis news is developing as rapidly as any area of the law, and there are only so many hours in a day. I’ll admit up front that this was a close call.

There could be some angle that I’m not quite getting that would allow for unlicensed marijuana sales in states that have adopted marijuana licensing regimes, but I’m leaning towards thinking this may be one of the silliest, most obvious cases I’ve seen in years (and I see some wild cases in this line of work).

9. Because I Got High: Settlement Reached in Terminated Hemp User’s Disability Bias Suit

Authors: Caroline Bradley-Kenney, Whitney Jackson

When can you rely on a positive drug test to terminate an employee? If the employee suggests a reason for a false positive, like hemp use, can you still side with the drug test? The Sixth Circuit’s decision in Fisher v. Airgas USA, LLC, et al. is instructive.

Blowing Smoke

In October 2019, Airgas hired Murray Fisher as an “operations technician.” A month later, doctors diagnosed him with liver cancer. In August 2020, doctors told Fisher that he needed surgery. Around that time, he requested accommodations for medical leave and for time off to attend doctors’ appointments. Airgas granted both requests.

Fisher had surgery and Airgas gave him eight weeks of medical leave. Fisher returned to work in October 2020. Due to ongoing pains, Fisher began taking a product called “Free Hemp” to offset symptoms.

In November 2020, Airgas selected Fisher for a random drug test. A contractor, HireRight, reported that Fisher’s sample was positive for “marijuana.” Fisher told Airgas he did not use marijuana and asked for a retest, explaining that his use of Free Hemp might have caused a false positive.

10. Meet the New Boss, Same as the Old Boss? The Impact of a Second Trump Presidency on American Cannabis Policy

Author: Whitt Steineker

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.

Listen to this post

Well, our Matt Gaetz post was short lived. And, in hindsight, that should come as no surprise given the overwhelming opposition and allegations that continued to emerge. If you are a frequent reader of Budding Trends, however, you know we try to stay on top of the unending news cycle that is the cannabis industry and keep the masses up to speed. So, here we are again. Yesterday, the news broke that Gaetz withdrew his name, reportedly because the Trump administration concluded he would not have the votes to be confirmed. Little time passed before the new nominee was named. Enter former Florida Attorney General Pam Bondi.

Disclaimer: As we state in all posts that relate to politics, we strive to avoid any semblance of partisan commentary in this space and, because this is a cannabis law blog, aim to focus exclusively on how current events or legal developments impact the cannabis industry. This article is no different.

Back to how an Attorney General Bondi may affect the cannabis industry. The former prosecutor, who served as Florida’s head attorney from 2011-2019 before working for the Ballard Partners lobbying firm and then joining Trump’s legal defense team during his first impeachment trial in 2020, has not had the most pro-marijuana positions in her tenure. If we’re being honest, what we know isn’t going to make cannabis operators feel all warm and fuzzy, but at the same time, all hope shouldn’t be lost.

As Florida AG, Bondi Opposed 2014 Florida Amendment 2

Before Florida Amendment 2, which would have legalized medical marijuana in Florida, landed on the ballots in the 2014 election and then failed to receive the requisite votes, Bondi’s office challenged the legality of the ballot initiative. In their filings, Bondi argued the amendment would have made Florida “one of the most lenient medical-marijuana states, allowing use for limitless ‘other conditions’ specified by a physician.” While Bondi’s efforts then to keep the measure out of voters’ hands failed, the votes to pass the amendment weren’t enough.

Amendment 2 Passes in 2016, Without Bondi’s Opposition

Unlike in 2014, Bondi’s office did not formally challenge the 2016 amendment. Instead, her office simply stated that she was concerned the new law would expand the use of marijuana among Floridians, especially in the youth population. The 2016 Amendment 2 ended up receiving over 71% votes in favor of medical marijuana, giving birth to one of the more robust medical marijuana programs in the country.

Bondi Tried to Uphold Smoking Ban in Medical Cannabis Law But Lost

The legislation that originally enacted Amendment 2 banned smokable forms of marijuana. Lawyers, led by famed personal injury lawyer John Morgan of Morgan & Morgan, challenged the ban and succeeded. Bondi’s office mounted opposition, arguing that because “elected members of Florida’s legislature emphasized that the amendment was exclusively about medicine… smoking is antithetical to good medicine.” Ultimately, the Florida Legislature heeded the lower court’s conclusion on the issue and passed SB-182 in 2019 to legalize smokable forms of marijuana within Florida’s medical marijuana program.

Bondi Has a Strong Track Record Fighting the Opioid Crisis and Draws Praise from Trulieve CEO Kim Rivers

During Trump’s first four years in office, Bondi served on his Commission on Combating Drug Addiction and the Opioid Crisis. She also has worked inside Florida to help stop the illegal use of prescription drugs and combat the fentanyl crisis. Kim Rivers, CEO of Trulieve, took to X to praise Bondi’s efforts in that respect and quelled concerns that Bondi would hinder cannabis reform, stating:

“I have always known her to be straight forward and very fair… She is passionate about ending the opioid crisis and did great work shutting down pill mills in Florida. She is an advocate for safe, regulated markets and I believe she will bring the same energy to end the fentanyl issues our country is facing.”

Based on the foregoing, while Bondi’s position on cannabis isn’t unambiguously pro or opposed, perhaps the cannabis industry can take some solace in the (likely) possibility that, if confirmed as attorney general, she will adopt a stance similar to that of President-elect Trump, Robert F. Kennedy, Jr. (nominee for new head of U.S. Department of Health and Human Services), and others in the Trump administration on marijuana. At this point, all we can do is wait and see.


As always, stay tuned.

Listen to this post

No, it’s not (just) a cruel play on words. Last week, the Drug Enforcement Administration announced that a much-anticipated public hearing on the proposal to reschedule marijuana would be moved from early December until the first quarter of 2025. I’m not sure I specifically predicted this, but it’s just about the most predictable thing ever. And it has a number of people thinking (wrongly in my opinion) that rescheduling may not even happen given the results of the recent elections.

Our friends at Marijuana Moment did a nice job laying out the facts:

After DEA Administrator Anne Millgram signed off on over two dozen witnesses to participate in the hearing on Monday, Chief Administrative Law Judge (ALJ) John Mulrooney issued a preliminary order on Thursday signaling that the information provided on those set to testify was insufficient and requesting additional details and potential availability for a formal hearing in January or February 2025.

…

The reason being is that DEA’s list of hearing participants who were selected and sent to the ALJ’s office provided “no indication in the four corners of the document as to whether the ‘participants’ support or oppose the [notice of proposed rulemaking] or how the ‘participants’ satisfy the ‘interested person’ definition set forth in the regulations,” the judge’s order says.

…

The order from the DEA ALJ says that selected participants must provide such details by November 12. DEA is mandated to provide “its counsel(s) of record who will be appearing in these proceedings, as well as any known conflicts of interest that may require disclosure” on the same date.

…

This comes about seven months after the Justice Department formally proposed moving cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA) following a scientific review. After a public comment period, which saw tens of thousands of people weigh in on the issue, a hearing was set for December 2 to gather additional expert input.

…

DEA has already made clear that it feels additional information is needed on a number of topics related to the scientific review into marijuana that led to the reclassification recommendation. Some view the scheduling of the hearing as more evidence of DEA skepticism.

Look, rescheduling marijuana was never going to be quick or come without hiccups and even setbacks. Paul Armentano, deputy director for NORML, said that “it’s always been a possibility that this process could drag out longer than many either anticipated or would like… The administrative process is cumbersome and, as we have seen historically, administrative challenges to marijuana’s Schedule I status take years to resolve,” he told Marijuana Moment.

A huge, unanswered, and probably unknowable question is whether the results of the elections last week will derail what appeared to be a fait accomplice just months ago. Anyone who tells you with absolute certainty what Donald Trump and the political appointees he tasks to run the DOJ, DEA, and FDA are going to do when it comes to federal cannabis policy is not a serious person.

Trump has expressed support for an adult-use marijuana regime in his home state of Florida (a ballot initiative that ultimately received just under the 60% threshold to become law), and we have previously written about how, during his first term, Trump was largely “cannabis ambivalent.”

It is perhaps understandable, though, to wonder if maybe a Republican administration may not move with the same sense of urgency during the rescheduling process. Or, a frightening thought for industry advocates, Trump could appoint a cannabis hardliner that affirmatively seeks to stop rescheduling. That would certainly lead to litigation that could last years.

Given the seemingly bipartisan popular support for rescheduling, the fact that the train is already starting down the tracks, and the fact that I believe Trump is unlikely to devote political capital to stopping rescheduling, I continue to believe that rescheduling is on the horizon, even if that horizon is a little further away than some may wish.

Listen to this post

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.

Listen to this post

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.

Listen to this post

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…

Listen to this post

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.