By: Ritika Dubey

Lawmaker Michael Grieco introduced a bill to legalize psilocybin-assisted therapy in the Florida state legislature on January 28. Florida could soon join Oregon in implementing a model that legalizes psilocybin-assisted therapy closely resembling Oregon Measure 109.

Truffle Report got in touch with Dustin Robinson, co-founder of Mr. Psychedelic Law, to talk about the recent psychedelic legalization and decriminalization trends in the United States as well as his role in the constantly evolving psychedelic legal landscape. Mr. Psychedelic Law is a non-profit repository of lawyers, medical, scientific, and spiritual experts, working towards driving a “responsible legal reform in Florida for psilocybin.” Robinson worked with Representative Grieco in part to design the first draft of the state psilocybin bill.

The bill HB 549 notes ways of ensuring equitable access to psilocybin, which under the proposed model, will be administered by licensed service centres or facilities.

“Unlike Oregon, I have put down a language in the bill related to telehealth using virtual sessions to the administration of these substances,” Robinson says. He adds that virtual therapy would help reduce the cost of one-to-one therapies where a person can have a therapist remotely, and where a designated sitter is present with the patient at the time of consuming psilocybin. “There’s going to be rules around it but what I am envisioning is that you have to designate a sitter to be there with the person. It will hopefully drive some equity and help reduce the cost,” he adds.

“In the draft bill, we have worked on both the legalization framework and decriminalization framework,” Robinson says as he gives details about the draft. Florida’s legalization bill closely follows the Oregon model, inspired by Measure 109 that legalized psilocybin-assisted therapies and Measure 110, decriminalizing simple possession of all drugs.

Moreover, if the decriminalization language added in the first draft is approved in the legislature, Robinson says, “I can see a world where home-grow is allowed.” Considering the cost-effectiveness related to the requirement of land or labour in the production cycle, it’s a possibility that residents of Florida may be allowed to grow their own psilocybin mushrooms for the therapy.

Understanding the Ongoing Changes in Local U.S. Drug Policies

Florida isn’t an isolated case. The U.S. is seeing a gradual shift in drug policies at the local and state levels as grassroots organizations and activists continue to fight against deeply flawed War on Drugs policies. Many jurisdictions are gearing up to take on the fight at a larger level after Oregon became the first state to decriminalize possession of all drugs and legalize psilocybin-assisted therapy in November 2020.

“Three things are happening,” Robinson says. He explains: “There is decriminalization happening at a city level. From a state perspective, you have states like Oregon that are creating a legal framework. Third, which is the most interesting is that FDA [Food and Drug Administration] has designated MDMA and psilocybin as ‘breakthrough therapies’.”

Various cities and jurisdictions including Denver, Oakland, and Washington D.C. have successfully pushed their local governments in making possession of entheogenic plants and fungi the lowest priority of law enforcement. While this is the most prevalent scenario, some city councils like that of Somerville, Massachusetts also decriminalized possession of all drugs.

On the state level, Oregon is the first state to lead the wider-scale movement. Oregon entered a two-year development programme dedicated to developing a legal framework within which licensed practitioners will be able to provide services in a safe environment.

Talking at greater length about FDA designations, Robinson says, “unlike the cannabis industry, you’re seeing that the FDA is working more preferentially for some of the psychedelic substances as compared to cannabis.”

Robinson explains that “The difference between psychedelics and cannabis could be broken down like this: the cannabis industry is mainly driven by the recreational use of cannabis, and I think, as the industry develops, you’re going to see moving towards recreational. In contrast, the psychedelic industry is mainly driven by science, research, and the pharmaceutical industry.”

He continues, “The way I see the psychedelic industry progressing is through the biopharma framework compared to the cannabis industry which is being driven by the recreational consumer-brand type market.”

All these changes combined are slowly advancing larger drug policy reform in the U.S. That reform is also likely to be surrounded by uncertainties for the immediate future, depending on the benefits of psychedelic-assisted treatments that are yet to surface from the ongoing MDMA and psilocybin studies, and stigma related to drug use in communities across the country.

“It’s going to be very hard,” Robinson says of federal-level changes in drug policies, but he also hinted at some positive shift that the Biden administration is capable of making, considering his son’s struggles with opioids and the public knowledge of his ibogaine treatment. “I don’t think it is unrealistic that there’s going to be some change in the next four years,” Robinson adds.

By: Dustin Robinson & Steven Avalon

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (“Federal Right to Try Act”), was signed into federal law May 30, 2018 as a direct result of similar laws in 41 states, including Florida. Florida’s Right to Try Act (Senate Bill 1052: Experimental Treatments for Terminal Conditions) was signed into law in July 2015 and allowed Florida terminally ill patients to undergo non-FDA approved treatments for their illnesses, while also absolving manufacturers of the drugs, products, and devices used for said treatment of any liability.

The Federal Right to Try Act, which is a reflection of the state laws which preceded it, allows terminally ill patients to seek investigational treatments for their diseases. To qualify as an eligible patient under the Federal Right to Try Act, an individual must:

1. Be diagnosed with a life-threatening disease or condition;
2. Have exhausted approved treatment options;
3. Be unable to participate in a clinical trial involving the eligible investigational drug, as certified by a doctor, who is in good standing with her licensing organization and will not be compensated directly by the manufacturer for so certifying; and
4. Give written informed consent regarding the risks associated with taking the investigational treatment.

However, only certain drugs and treatments qualify. Specifically, a drug or treatment must:

1. Have completed an FDA-approved Phase 1 clinical trial;
2. Be in an active clinical trial intended to form the basis of an application for approval or be the subject of an application for approval that has been filed with the FDA; and
3. Be in ongoing active development or production and not discontinued by the manufacturer or placed on clinical hold.

With the recent legalization efforts surrounding psilocybin and other entheogenic plants, many of our clients have asked about psilocybin as related to the Federal Right to Try Act. Psilocybin has completed an FDA-approved Phase 1 clinical trial (Compass Pathways and Usona both currently have Phase-2 trials ongoing) and has been granted “breakthrough therapy” status by the FDA (see our blog here for a brief discussion of what a breakthrough therapy designation is). Therefore, psilocybin qualifies as a drug that fits squarely within the language of the Federal Right to Try Act, which mirrors Florida’s Right to Try Act.

An eligible patient does not need to apply to the FDA. Instead, the eligible patient and their treating physician must follow the requirements of the Right to Try Act. For an eligible patient to lawfully use psilocybin under the Right to Try Act, an eligible patient or their legal representative must first provide “written informed consent” to their treating physician about using psilocybin. Under the federal Act, there is not a definition or outline specific requirements for “written informed consent.” Therefore, it is unclear what specific consent an eligible patient must provide their physician looking only at the Federal Right to Try Act. To understand what is required of “written informed consent,” we must look to state law. Each of the 41 states with a state Right to Try Act has its own requirements. Under s. 499.0295 (2)(d) Fla. Stat., Florida defines “written informed consent” as:

1. An explanation of the currently approved products and treatments for the patient’s terminal condition;
2. An attestation that the patient concurs with his or her physician in believing that all currently approved products and treatments are unlikely to prolong the patient’s life.
3. Identification of the specific investigational drug, biological product, or device that the patient is seeking to use;
4. A realistic description of the most likely outcomes of using the investigational drug, biological product, or device. The description shall include the possibility that new, unanticipated, different, or worse symptoms might result and death could be hastened by the proposed treatment. The description shall be based on the physician’s knowledge of the proposed treatment for the patient’s terminal condition;
5. A statement that the patient’s health plan or third-party administrator and physician are not obligated to pay for care or treatment consequent to the use of the investigational drug, biological product, or device unless required to do so by law or contract;
6. A statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins treatment with the investigational drug, biological product, or device and that hospice care may be reinstated if the treatment ends and the patient meets hospice eligibility requirements; and
7. A statement that the patient understands he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that liability extends to the patient’s estate, unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise.

Once an eligible patient or their legal representative provides the treating physician written informed consent, the physician and patient must contact a manufacturer of the desired substance. To acquire a psilocybin product in the United States, an eligible patient must look towards the companies currently undergoing clinical trials of psilocybin products. Therefore, an eligible patient and their treating physician would be allowed to contact Usona or Compass Pathways to acquire psilocybin products under Right to Try. If a psilocybin manufacturer agrees to provide the eligible patient psilocybin products, there are no further requirements.1 In other words, neither the eligible patient nor the treating physician are required to contact the FDA or any other federal agency about the eligible patient’s use of the psilocybin product.

Psilocybin’s “breakthrough therapy” status and other milestones show that the US is beginning to accept the medical benefits of psilocybin. Furthermore, Right to Try under federal and state law allows patients to enjoy these benefits of investigatory substances prior to widespread FDA approval. Therefore, terminally-ill individuals would be permitted to use psilocybin to treat their illnesses under the Federal Right to Try Act and the Florida Right to Try Act. The biggest challenge right now is getting Usona or Compass Pathways on board with supplying such medicine.

1. Byrne, Jennifer. “Right to Try: A ‘Well-Intentioned’ but ‘Misguided’ Law.” Healio, 10 Mar. 2020, www.healio.com/news/hematology-oncology/20200303/right-to-try-a-wellintentioned-but-misguided-law.

By: Ben Ari

 

As a part of my series about “5 things I wish someone told me when I first became an attorney”, I had the pleasure of interviewing Dustin Robinson.

Dustin Robinson is the Founding Partner of Mr. Cannabis Law. Dustin is licensed in Florida as an Attorney, a Certified Public Accountant, and a Real Estate Agent. He focuses his practice on providing legal, accounting, financial, and business consultation to various businesses operating in the hemp, marijuana, and psychedelic industries.

Dustin is also the co-founder of Mr. Psychedelic Law — a 501(c)(4) focused on using medical and spiritual research to drive responsible legal reform in Florida for psilocybin mushrooms and other entheogens. Dustin has drafted Resolutions for psychedelic decriminalization for various cities in Florida and hopes to build a responsible legal framework in Florida for the commercialization of psilocybin mushrooms and other entheogens. Dustin has built a team at Mr. Psychedelic Law that consists of the top lawyers, lobbyists, doctors, scientists, and spiritual leaders in the state of Florida. Dustin — through Mr. Cannabis Law — also represents various psychedelic non-profits including Mind Army and Ketamine Fund.

Thank you so much for joining us! Our readers would love to get to know you a bit more. What is the “backstory” that brought you to this particular career path in Law?

Well, I kind of had a different path to starting my own law firm compared to most. Prior to law school, I obtained my CPA and worked at a Big Four accounting firm — Deloitte. After law school, I worked in Big Law — Holland & Knight. Then, I took a detour from law by transitioning to a more operational and entrepreneurial role helping run and build one of the top roofing-manufacturing-companies in the country — Tropical Roofing Products. Once I sold my interest in Tropical Roofing Products, I was looking for a venture that would utilize my diverse skill set as an entrepreneur, attorney, CPA, and licensed realtor, while also having an impact on the world.

A friend had a cannabis license and needed help doing a deal with another company that had a cannabis license in another state. I was able to assist with the transaction, utilizing my legal, accounting and real estate background. I found it fascinating the need to learn a completely new and emerging area of law — cannabis law — in order to successfully structure the transaction. I also found it interesting that my old law firm, Holland & Knight, wasn’t willing to represent companies in the cannabis industry due to the industry being federally illegal. There was a clear need in the market for a law firm that provided cannabis businesses with Big Firm-type of expertise, with a narrow focus on the cannabis industry. So, as an entrepreneur, I decided to fill that market void by starting my own law firm that exclusively focuses on the cannabis industry, Mr. Cannabis Law. Since then, my firm has expanded its focus to also include the psychedelic industry, which is one of the most emerging industries in the country. Working in these two industries fulfills my desire to always be challenged and my desire to have a positive impact on the world.

Can you share the funniest or most interesting story that occurred to you in the course of your law career?

I generally counsel cannabis companies to not use words in their name that indicate that they work in the cannabis industry because it causes challenges with banking, insurance, social media, etc. However, I purposefully called my firm “Mr. Cannabis Law” because I wanted to experience the challenges that are attached to having a company with the word “cannabis” in it, so that I can better counsel clients on overcoming those challenges. I found it interesting that Facebook and other social media sites were even more strict than some of the banks and insurance companies. For example, my Facebook page was taken down within 24 hours of it being live; and Instagram still periodically blocks my post. It is already hard enough to launch a new company, however, when you’re operating in the cannabis industry, you have to deal with whole a new set of challenges.

What are some of the most interesting or exciting projects you are working on now?

I recently launched a psychedelic division of my law firm that is focused on providing legal and business assistance for clients looking to launch companies in the psychedelic industry. For example, one company we are representing is KetaMD, which is a platform for virtual psychedelic-assisted therapy using ketamine. KetaMD is revolutionizing the way we address mental health in the United States. We also represent various non-profits in the psychedelic space, like Mind Army and the Ketamine Fund. Through this work, I have learned about the tremendous therapeutic value of psychedelics; and I’m excited to work through my own non-profit — Mr. Psychedelic Law — to push legal reform of psychedelics.

What are some of the most interesting cases you have been involved in? Without sharing anything confidential can you share any stories?

Due to attorney-client privilege, it’s hard to say much about cases in which I’ve been involved. However, what I can say is that I’ve represented various businesses in partnership disputes. Entering into a partnership is like entering into a marriage. Everyone enters the partnership with the best of intentions but oftentimes things go sideways. That’s why I counsel clients to really make sure they spend the money on legal fees on the front-end clearly outlining the rights, responsibilities, and obligations of the partners rather than spending the money on legal fees on the back-end once a dispute has arisen. Early in my career, I dealt almost exclusively with dealing with the disputes on the back-end. Now I spend more of my time on the front-end with structuring the transactions, which I enjoy more.

Which people in history inspire you the most? Why?

Gary Vaynerchuk is probably the person who has inspired me the most. He has a “no excuse” attitude towards business and life, but also preaches the importance of empathy. A piece of his advice that resonated with me and inspired me to start my law firm is: “There no longer has to be a difference between who you are and what you do.” While working at Big Law and Big Accounting, I conformed to fit the profile of a professional accountant or professional attorney with no individuality. Now, with my law firm, I’m able to truly be myself; advocate on the issues I believe in, and drive legal reform that will ultimately lead to a better world. My law firm and the services it provides are a clear reflection of who I am and what I believe in. I couldn’t imagine it any other way.

What advice would you give to a young person considering a career in law?

Find your purpose. A license to practice law provides you with opportunities in so many different areas. Do you want to lobby for legal reform? Do you want to represent the injured? Do you want to represent people who are arrested? Do you want to use your law degree to operate a business? Spend your first few years out of law school finding your purpose. And, once you’ve found your purpose, be hyper-focused on being the absolute best in that category.

If you had the ability to make three reforms in our judicial/legal system, which three would you start with? Why?

Deschedule marijuana, deschedule psychedelics, and provide social equity to those that were disproportionately impacted by the war on drugs. This would improve society in the following ways: (1) it would significantly improve unemployment; (2) it would generate tremendous tax revenues to federal and state governments; (3) it would stimulate the economy; (4) it would allow further research to be done with these substances so that we can recognize their true therapeutic value; (5) it would right the wrongs of society through various social equity programs, including expungements and preferences within the industry; (5) it would allow humans to reclaim their inalienable right to determine their own relationship with nature; and (6) it would allow humans to reclaim their inalienable right to control their own mind and reach elevated states of consciousness.

How have you used your success to bring goodness to the world?

I sit on various boards on non-profits and governmental bodies that all promote social equity and the use of improving health through the use of highly regulated substances. I am on the Board of Directors of Minorities for Medical Marijuana, where I assist with social equity legal reform and ensuring that the future of the cannabis and psychedelic industries is inclusive and equitable; I am on the Legal Committee of Florida Hemp Council where I helped set up one of the first minority hemp co-ops in the state of Florida; and I am on the Broward County Medical Marijuana Advisory Board where I’ve advocated for various rights for medical marijuana patients, including employment protections. I also founded Mr. Psychedelic Law, which is a non-profit with a mission to drive responsible legal reform for psilocybin and other psychedelic substances. Through the non-profit, we will improve mental health across the world and will restore some of the most basic of human rights.

I know this is not an easy job. What drives you?

Myself! My best coach is my personal voice. My personal voice creates stories, and those stories manifest the reality that I desire. Too many people create false narratives in their heads, which is self-perpetuating and creates a negative reality. A positive mindset will increase your productivity, improve your mood, and help you manifest the reality you desire for yourself. Once you’ve mastered the power of a positive mindset, you’ll be positively driven to think big and execute big.

What are your “5 things I wish someone told me when I first started” and why. Please share a story or an example for each.

My brother is seven years older than me and is also an attorney. He and many of his other attorney friends have served as my mentors since the very beginning of my career. As a result, I was fortunate to receive plenty of solid advice from experienced attorneys when I first started. Here are 5 pieces of advice that I’ve found most helpful:

  1. Find mentors. Mentors can help you reach your full potential by helping you avoid common pitfalls and guiding you through the process. A good mentor will also hold you accountable.
  2. Find your purpose. This might take time and it will likely continue to evolve. But, once you know your purpose, you can achieve anything.
  3. Foster your relationships. In your first few years as an attorney, your value to your firm is mainly keeping your face in the computer. That was certainly the case for me. But don’t neglect the importance of relationships. As you get further in your legal career, your relationships will become your most valuable asset.
  4. Stay physically and mentally healthy. Law school breeds a competitive attitude where people develop the mindset that they can outwork the other students by making schoolwork the highest priority in life. When you’re young, you can maybe get away with not taking care of your physical and mental health. But life is a marathon, not a race. An unhealthy lifestyle is not sustainable. If you prioritize your physical and mental health, you will outperform your professional competition in the long run.
  5. You can manifest your future. You are in complete control of your life and your decisions. Adopt a positive mindset. Set goals. Believe you can achieve those goals. And go execute. Once you’ve realized you are in complete control of your destiny, you can start to manifest the future you desire.

We are very blessed that some of the biggest names in Business, VC funding, Sports, and Entertainment read this column. Is there a person in the world, or in the US whom you would love to have a private breakfast or lunch with, and why? He or she might see this. 🙂

I would choose to go to breakfast with Mark Cuban. I’ve always admired Mark as an impact investor, a leader, a father, and an all-around solid citizen. Not only does he identify investments that earn a great ROI, he also identifies investments that have social impact (VOI). Mark has also been vocal about revolutionizing health care over the years. If I had breakfast with Mark Cuban, I believe he’d be on board with partnering so we can, together, change the world of health care.

Thank you so much for this. This was very inspirational, and we wish you only continued success!

By: Kevin E.G. Perry

After being diagnosed with clinical depression as a teenager, Warren Gumpel spent years swallowing handfuls of antidepressants that would often leave him feeling “catatonic”. Then, during a severe depressive episode five years ago, Gumpel turned to a New York clinic offering a relatively new form of depression treatment: ketamine infusion therapy. The results were immediate, and transformative.

“The SSRI mixtures I was taking would just suppress my emotions,” says Gumpel, speaking over Zoom from his home in Florida. “But ketamine expands your consciousness and even grows grey matter in your brain. It’s the most incredible way to deal with things that you didn’t know were in your subconscious, things that affect the decisions you make every day.”

Gumpel felt so liberated by his experience with ketamine that he became a vocal advocate for the treatment, encouraging friends and family members who were dealing with depression to try it for themselves. Together with his business partner, Mike ‘Zappy’ Zapolin, Gumpel founded The Ketamine Fund, a non-profit that has donated over 400 treatments to military veterans. Their next venture is KetaMD, an online ketamine clinic set to open this year which they hope will help widen access to the treatment by allowing it to be prescribed over a video call.

Still best known as a party drug, ketamine’s reputation as a new type of antidepressant has grown steadily in recent years. It was first synthesised in 1962 by Calvin L Stevens, a chemist in Detroit who was trying to develop a more manageable alternative to PCP to use as an anaesthetic. By 1970 it had been approved by the FDA and was being given to American soldiers fighting in Vietnam, where it proved revolutionary as, unlike other anaesthetics, it barely affects the respiratory system. That meant medics could operate on the battlefield without breathing machines. Still more remarkably, anecdotal reports began to emerge that even soldiers who’d had their limbs blown off were less likely to experience post-traumatic stress if they’d been given ketamine. By the 90s, studies of soldiers returning from the Gulf War showed that using ketamine greatly reduced the prevalence of PTSD, spurring curiosity about its potential for therapeutic use.

Subsequent research at the Yale School of Medicine set the standard for today’s ketamine infusion therapy. As Gumpel explains, this means patients typically receive a 45-minute intravenous or intramuscular ketamine infusion six times over the course of two to three weeks. They then return for a further infusion ‘top-up’ once they feel their symptoms return, with the aim that over time these top-ups are needed less and less frequently. Between 2015 and 2018, the number of American clinics offering this sort of treatment jumped from 60 to over 300.

Part of this boom in popularity is because, unlike traditional antidepressants which take weeks to start having an effect, ketamine has been shown to alleviate symptoms of depression within hours of receiving the first infusion – even for patients like Gumpel, who have ‘treatment-resistant’ depression. He describes the experience of receiving a ketamine infusion in psychedelic terms: “Commonly I see a fabric that doesn’t allow me to see where I end and somebody else begins. There’s no distinction between me and another person, or even me and the furniture. It’s all just one big connected thing, and there’s something very comforting about that. It feels like the whole universe is within (reach) to you, and yet you also feel like a speck of dust at the same time. You feel like nothing and everything at once. It’s so liberating.”

The experience that patients have during the infusion is key to the success of ketamine treatments. Exactly why the drug is so effective in fighting depression remains something of a mystery, although it’s thought to be due to the multiple ways in which the drug affects brain function. Firstly, ketamine is an NMDA inhibitor, which acts as a painkiller and gives the drug its dissociative effect. Secondly, it has been shown to encourage the regrowth of neurons and synapses in the brain, which is significant as a reduction in neurons and synapses is closely associated with depression. Thirdly, ketamine acts on an area of the brain called the lateral habenula, the region which mediates negative emotions. Dysfunction in the lateral habenula is linked to depression, schizophrenia and drug-induced psychoses, but this can be reversed by ketamine infusion therapy. “It’s not just one thing,” says Dr Joseph Rosado, a Florida-based physician who is advising KetaMD. “It’s a combination of things, and that’s what makes it such a novel treatment in therapy.”

Ketamine infusions are usually only available in a doctor’s office or other clinical setting, but KetaMD’s aim is to offer ‘at-home’ treatments. Patients will speak to a doctor during an online TeleMed consultation, and then once ketamine lozenges have been mailed out each infusion session will be guided by a nurse using the same technology. This is only possible because of new guidelines brought in as a response to the coronavirus pandemic. “During this health emergency there’s been an exception to The Ryan Haight Act, which is a federal law that essentially doesn’t allow controlled substances to be prescribed through virtual meetings,” explains Dustin Robinson, KetaMD’s legal advisor. “During corona, doctors have been allowed to prescribe controlled substances remotely.”

Both Gumpel and Zapolin say they see widening access to ketamine therapy as a important tool in dealing with America’s epidemic of suicide, addiction and depression – something which has only worsened during the pandemic. Statistics from the CDC published last summer stated that one in four young adults between the ages of 18 and 24 had considered suicide in the past month due to the pandemic. “We’re trying to get to the millennial audience who are hurting in a big way out there,” says Zapolin. “What I love about ketamine is that it’s not just for treatment-resistant depression. It’s for people who have PTSD, which is pretty much everyone right now. If you’ve lived through coronavirus, you have PTSD. It’s important we open this up and make it the first stop in mental health instead of the last stop after nothing else has worked.”

Zapolin believes that ketamine therapy will soon become mainstream – and argues that it could even challenge the big pharma companies who have a clear profit incentive to keep patients on a steady diet of antidepressants year after year. “What’s exciting is that, as big and powerful as pharma is, what’s bigger and more powerful is the insurance industry,” he says. “The insurance companies don’t want to keep paying for all these expensive medications. Ketamine is very cost-effective, so I think eventually when they have the data they’re going to tell the pharma companies, ‘Hey, sorry, we’re not paying for your stuff anymore.’”

In the UK, research into ketamine therapy for patients with treatment-resistant depression has been spearheaded by Dr Rupert McShane, a consultant psychiatrist at Oxford Health and researcher in Oxford University’s Department of Psychiatry. He has been carrying out studies at the Oxford Health NHS Foundation Trust since 2014, and is cautiously optimistic that ketamine could indeed prove to be a useful treatment for a variety of other conditions. “There is already some data to support its use in treating PTSD, bipolar, eating disorders, substance misuse and social anxiety, but not enough to support widespread use,” he says. “Getting enough data is so expensive, and the barriers to use so low, that it is inevitable ketamine will be used outside treatment-resistant depression before we have enough data to be sure. This creates a real risk of overuse, stigma and backlash. The only way to manage this risk, given where we are, is transparent, detailed monitoring of use outside clinical trials.” As for whether this sort of therapy will become easier to access in Britain, he adds: “The NHS will rightly be cautious, but I do think it likely that ketamine will eventually become a mainstream treatment.”

For Gumpel, the day that ketamine becomes as easy to access as traditional antidepressants can’t come soon enough – and he says potential patients shouldn’t be put off by the drug’s hard-partying reputation. “The ‘Special K’ association is there, but we have to remember ketamine is very widely used and very safe – it’s on the World Health Organisation’s list of the most essential medications in the world,” he points out. “I’d love to see a paradigm shift right now when we need it the most. I want more people to be able to get ketamine, and I really want more people to get ketamine before they get stuck on Prozac.”

By: Chris Roberts

A Florida state lawmaker plans to introduce as soon as next week a bill that would legalize psilocybin-assisted therapy in the state.

Modeled after a recent voter-approved initiative in Oregon, the proposal from State Rep. Michael Grieco, a Democrat who represents Miami Beach in the state Legislature, represents the first serious push for legal access to psilocybin on the East Coast.

It’s also the first effort to legalize magic-mushroom access in a red state, and a potential test case that could demonstrate that like cannabis legalization, access to legal psilocybin is also a bipartisan issue.

“I know at least two people personally who have gone through microdosing sessions, and they claim it’s completely cured their depression,” Grieco said in a recent telephone interview. “All this would be doing is creating a controlled environment, where folks can potentially address an issue. We should not be afraid of trying new things, especially if it’s controlled and safe.”

Voters in Washington, D.C. recently approved a measure asking the Metropolitan Police Department to stop arresting adults in possession of psilocybin mushrooms.

What Grieco is proposing includes legal access as well as legal consumption, an increasingly popular idea that until now has only gained serious traction on the West Coast.

Drafted in part by Florida attorney Dustin Robinson, the bill’s language is still being finalized, Grieco said Friday, but the plan is to follow to the model provided by Measure 109 in Oregon.

Approved by voters on Election Day, Measure 109 directs the Oregon Department of Public Health to allow therapists to provide psilocybin to patients under their care suffering from depression, PTSD, and other mental-health problems in a controlled setting. That program won’t launch for another two years.

In Florida, access would be limited to people with a diagnosis of a mental-health condition. In Florida, that would mean legal access to mushroom-assisted therapy for military veterans with PTSD—and there are at least 1.5 million military veterans in the state, the third-most in the United States behind California and Texas.

Grieco plans to focus on veteran access, he said. “There’s a black market for this in Florida anyway,” he said.

Once the bill’s language is approved—an “administrative review” process is still underway—it could be formally introduced in the Legislature as soon as next week, Grieco said.

Mushroom legalization is likely to meet serious opposition in Tallahassee, from both other lawmakers as well as public-health officials, Grieco admitted. That means the bill is unlikely to pass this session—and that’s okay.

Instead, the bill will trigger a conversation—as well as interest from Florida universities hoping to study psilocybin’s therapeutic potential, and, along with it, demand from voters, Grieco predicted.

“Florida is usually the last to do most things, whether it be medical marijuana or a slew of other issues,” Grieco said. “Even if it’s a Hail Mary bill, if the bill turns into a conversation, and that turns into a study at one of the universities… Someone in government needs to say, ‘You know. This is a good idea. Let’s talk about it. Let’s not be afraid.’”

Mainstream academia is recognizing psilocybin’s value as a treatment technique for stubborn conditions like depression, addiction, and PTSD.

The federal Food and Drug Administration (FDA) has granted psilocybin “breakthrough therapy” status, a designation meant to speed along research and development of pharmaceutical treatments for “serious conditions.”

And in late 2019, researchers at Johns Hopkins University in Baltimore launched the “Center for Psychedelics and Consciousness Research,” thought to be the first dedicated to understanding how psychedelic compounds—including MDMA as well as psilocybin—affect the human brain.

If Florida’s experience with cannabis is any indication, voters could expect to decide on mushroom access via the ballot in a few years’ time. Florida voters legalized medical marijuana in 2016, and there is wide speculation that a ballot measure to legalize adult-use cannabis is forthcoming.

According to Robinson, the attorney who worked with Grieco to draft the language—and who wants to work with therapists interested in setting up treatment clinics in Florida—this first push towards legalizing psilocybin on the East Coast will likely pick up steam in other states as well.

“This bill symbolizes the seed that will soon blossom into the widespread acceptance of psychedelics, which will ultimately lead to the healing and compassion that our society desperately needs,” Robinson said.

Cannabis overcame deep-seated cultural resistance as well as millions of dollars in opposition spending to become (at least in Florida) semi-legal. Mushrooms don’t trigger the same resistance from law-enforcement or conservatives. At the same time, unlike cannabis, the most widely used illicit drug on the planet (in the places where it’s illegal), the general public is less familiar with mushrooms.

For that reason, in order for Grieco’s effort to become law, in some way, at some time, “this is really something that’s going to have to come strictly from research and the medical community, from veterans and suicide-prevention groups,” Grieco said.

“But in five years, this is is going to look like a no-brainer,” he added.

By: Danny Reed

WASHINGTON, D.C. – The U.S. Department of Agriculture (USDA) has released its final rule on hemp production. The rule, which incorporates feedback provided to the agency by farmers and hemp industry advocates, is set to go into effect March 22, 2021.

“With the publication of this final rule, USDA brings to a close a full and transparent rule-making process that started with a hemp listening session in March 2019,” said USDA Marketing and Regulatory Programs Under Secretary Greg Ibach. “USDA staff have taken the information [hemp farmers and advocates] have provided through three comment periods and from [farmers’] experiences over a growing season to develop regulations that meet Congressional intent while providing a fair, consistent, science-based process for states, tribes, and individual producers. USDA staff will continue to conduct education and outreach to help the industry achieve compliance with the requirements.”

Key highlights of the final rule from the agency include clarification of licensing requirements, record keeping requirements, cultivation procedures including information regarding the land used to grow, and testing procedures. The USDA also updated its requirements for disposing of non-compliant plants that test above the legal THC threshold. The agency acknowledged there currently are not enough DEA-registered labs to conduct testing. Under the final rule, non-DEA registered labs can test hemp plants until January 2022.

Reaction from hemp industry advocates seems to be mixed but hopeful.

“The rule is a clear sign that the USDA has listened to the farmers and is willing to bend,” said Jeff Greene, co-founder and director of business development for The Florida Hemp Council. “That said, it’s not perfect and there will be more room for improvement as the DEA test lab rule doesn’t even go into effect until 2022. Now that farmers have a clear direction, we need the FDA to step up and provide the final clarity to allow the cannabinoid industry a path to growth. Without that clarity, farmers can grow but if the crop isn’t in demand they will stop. Additionally, the government needs to get behind the industry with manufacturing block grants to spur innovation and additional uses for the plant.”

Attorney Dustin Robinson, founding partner at Mr. Cannabis Law and co-founder of Mr. Psychedelic Law, applauded hemp advocates and farmers for their commitment to the industry despite years of legal uncertainty.

“The improvements made in the final rule are a testament to the strength and resilience of hemp advocates and the hemp industry as a whole,” said Robinson. “The final rule is certainly not perfect but it demonstrates the federal government’s willingness and openness to work with the industry on finding solutions as we transition to a legal and regulated system. This transition has not been easy, and we have many challenges ahead. But this marks an exciting step forward for the industry.”

Although more adjustments to federal hemp regulations are possible, the road leading up to the USDA’s final rule has been long and winding. The 2018 farm bill first legalized industrial hemp but further clarification has been a slow process. Industry members—and those paying close attention to financial markets—have been eager for hemp and hemp-derived CBD to get the federal green light. While reports vary greatly, BDSA (formerly BDS Analytics) predicted the CBD market could soar as high as $20 billion in sales by 2024.

By: Tiffany Kary

Hemp, the staid sister of marijuana, is becoming much more interesting.

With its low THC content and lack of psychoactive effects, hemp has long been used for mostly practical purposes, like rope or fabric, or to produce CBD, a popular salve to relieve various ailments. But the marijuana industry is starting to take interest in a hemp-derived substance called delta-8 THC, which can be used to get high yet doesn’t have the same legal obstacles as stronger strains of cannabis.

And after regulatory changes last week loosened restrictions on hemp, its ability to compete with marijuana is likely to grow.

Delta-8 THC exists at very low levels in cannabis, while its more-abundant molecular cousin, delta-9 THC, is the one that’s usually targeted in regulations. The U.S. Department of Agriculture updated its rules Jan. 19 to increase the amount of THC in hemp that would trigger a “negligent violation” finding to 1% from 0.5%. While hemp is defined as cannabis that contains less than 0.3% THC content — and plants above that level still must be disposed of — the relaxed rules give manufacturers more leeway when growing and processing plants.

That means hemp production in general just got easier. And that’s a good thing for the CBD business, as well as delta-8.

“Delta-8 is the new kid on the block that everyone wants to dance with,” cannabis industry consultant Susanna Short told me recently.

Because delta-8 is made from CBD, it isn’t clearly regulated like delta-9 THC, which has traditionally been cited as the source of cannabis’ psychoactive effects.

Since the 2018 Farm Bill, hemp and CBD can be transported and sold freely within the U.S., unlike high-THC marijuana, which can only be grown and sold in states where it’s legal. The rules around delta-8 aren’t yet entirely clear, amid confusion over whether the Drug Enforcement Agency’s rules on synthetic cannabinoids apply to the substance, which is synthetically produced.

“It’s derived from hemp, so we’re taking the position it’s legal,” said Dustin Robinson, a Florida attorney and founding partner of Mr. Cannabis Law. He sees delta-8 as a cheaper and more convenient buzz for many people. “I can get high by getting delta-8 from a smoke shop or a gas station.”

That could pose a threat to multistate operators who have built their businesses to comply with tight rules around high-THC marijuana, especially after states like Illinois and Colorado last summer began allowing the hemp industry to sell through marijuana dispensaries. But it could also present an opportunity, Robinson said.

“This could be a means for the marijuana supply chain to reduce their cost of cultivation, if they can use hemp biomass instead of marijuana biomass,” he said.

Delta-8 has more going for it than legal ambiguity. Trulieve Cannabis Corp., which sells products with delta-8, extolls it as less likely to induce anxiety at high doses compared to delta-9, and cites studies that have linked it to appetite simulation, neuroprotective properties and anti-vomiting properties.

With potential like that, some companies aren’t waiting for regulatory clarity. Take Deep Six CBD, a retailer that just announced a rollout of delta-8 THC oil, vapes and edibles at a store in Pennsylvania. “Why pay $250 for a medical marijuana card?” the company’s president said in its news release touting the new product. “Try delta-8 THC first!”

By: Andrew Ward

Due to a lack of federal laws, the United States cannabis market is much more fragmented than Canada’s. Rather than a uniform code, each legal state market dictates its own set of rules. In many cases, American cannabis marketing laws largely resemble the alcohol space.

The laws can be daunting in any U.S. market. Dustin Robinson, a founding partner at Mr. Cannabis Law, said that medical markets tend to be more restrictive with packaging and advertising than recreational. Regardless, companies remain limited from becoming well-known brands on either side of the market.

Geography plans a significant hurdle. Due to federal prohibition, companies cannot operate across state lines as they wish. U.S. brands must obtain licenses in each state it intends to set up shop.

“This makes it very hard for multi-state operators to build a national brand with consistent and coherent messages to its patients and consumers,” said Robinson. He highlighted Cookies, a prominent brand with well-known imagery, and its recent entry into Florida, which has strict packaging laws. “It will be interesting to see how Cookies builds its brand image in Florida,” he said.