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PsychedeLinks – June 9, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

Medford Approves First Psilocybin Service Center
On May 25th, the Medford Planning Commission voted to approve plans for the launch of Shrooms Help Center, the city’s first psilocybin service center. The center will occupy a currently vacant building on Market Street, neighboring a nearby coffee shop and a wellness center. When complete, the treatment facility will boast six therapy “rooms,” including an outdoor area of approximately 8,000 square feet. As part of the approval process, the Commission conducted an in-depth review of Shrooms’ business plans, including parking, staffing, and business hours, with the only unique condition of the approval being the limitation of psilocybin administration hours to 8am - 11:59pm. The city’s approval of the service center is welcome news to current and prospective psilocybin facilitators, as many have expressed concern over the early disparity between the number of facilitator and service center licenses. While Shroom Help Center’s OHA license is still pending, if approved, the license will be the first service center license awarded in Medford since licensure began earlier this year. “We were concerned early on that some areas of the state would be underserved by psilocybin licensees. Would we end up with pockets of oversaturation in populated areas and other less populate regions wouldn’t have access to services at all? This approval allows for psilocybin coverage in a smaller jurisdiction and hopefully represents a continuing trend. It’s exciting to see service centers popping up throughout the state,” says Emerge attorney Alex Berger.

 Other Noteworthy News

Rhode Island Lawmakers Approve Psilocybin Legalization Bill
“A Rhode Island legislative committee this week approved a bill to legalize the possession and cultivation of psilocybin mushrooms. The measure, House Bill 5923, was approved by the House Judiciary Committee by a 12-2 vote on Tuesday, according to a report from Marijuana Moment. A companion bill is pending in the Rhode Island Senate, where the chamber’s Judiciary Committee is holding the bill for further study. If passed, the legislation would eliminate criminal penalties for adults who possess or cultivate up to one ounce of psilocybin mushrooms for personal use. Up to one ounce of mushrooms could also be shared by one adult with another. The bill is slated to go into effect on July 1.”
First-Of-Its-Kind Study Reveals How Psilocybin Therapy Helps Treat Alcohol Addiction
“[A] first-of-its-kind analysis released on Monday is offering novel insights into exactly how psychedelic-assisted therapy works for people addicted to alcohol. Researchers at NYU, UC San Francisco and the mental health practitioner training provider Fluence set out to investigate the therapeutic mechanisms that led a cohort of people with alcohol use disorders (AUDs) to significantly reduce negative drinking behavior after participating in an earlier landmark psilocybin clinical trial. The study, published by the American Psychological Association in the journal Psychology of Addictive Behaviors, revealed several common themes among participants that could help inform future research and therapeutic applications as more states move to promote psychedelic studies and regulated access. The study subjects almost universally said that they had experienced inner narratives that consisted of excessive blame, guilt and resentment toward people they were close to, and that inner voice was often self-critical and lended to intrusive thoughts. Another key takeaway from the qualitative analysis is that while the participants who went through the clinical trials generally reported fewer days drinking and reduced desire to drink, cravings didn’t fully disappear for everyone and it was understood that psilocybin on its own is not a panacea.”
What Does Good Psychedelic Therapy Look Like?
“As MDMA and psilocybin treatments become more mainstream, the therapy component has come under scrutiny. While there is mounting evidence that psychedelics could offer much-needed new treatments for intractable mental illness, stories of abuse or trauma have also emerged — which have more to do with the therapists than the drugs. Twenty years of research has standardized the dosage of the drugs used in clinical trials, but the therapy part has not received similar scrutiny. The lack of scientifically backed best practices has prompted researchers, clinicians and former patients to call for a more critical look at the therapeutic component of psychedelic therapy.” To Dr. Amy Lehrner, the clinical director of the Center for Psychedelic Psychotherapy and Trauma Research at the Icahn School of Medicine at Mount Sinai, “what researchers should be working to standardize now are general therapeutic principles while they continue testing whether the treatment as a whole is safe and effective. ‘Afterwards,’ she said, ‘people may investigate: ‘Well, what if we tweak it like this? What if we change it like that?’’”
LISTEN: Oregon is Moving to Legalize Psychedelics
“In Oregon, psychedelics are moving from illegal status to an approved product. But this brave new world comes with lots of regulations and challenges, including training psychedelic 'facilitators.' Deena Prichep reports.”

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PsychedeLinks – May 26, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

Synaptic Training Institute Won’t Open Psilocybin Service Center Because of “Cumbersome Process”
Synaptic Institute Inc., a facilitator training program based out of PDX, has halted plans to add a service center. Synaptic’s founder cited the “cumbersome” nature of licensing and running a service center as the primary driver for the decision. This statement echoes previously expressed concerns within Oregon’s psilocybin industry, largely prompted by the unique regulatory challenges faced by service centers as opposed to regulations for facilitators and facilitator training programs. Compounding these concerns are questions of tax and insurance liability, the required separation from other professional licenses, and a generally high cost of business. With only 3 service centers currently licensed in the state of Oregon, there is understandable concern among prospective psilocybin business owners that the state will see a surge of newly trained and licensed facilitators with little access to space in which to practice their craft. We are however in the very early days of the psilocybin industry, and a moderate surge in all licenses is anticipated throughout the year.

“Understandably, many prospective business owners in this space are coming to terms with the reality of start-up costs,” says Emerge attorney Kaci Hohmann. “There has been a lot of discussion in the community about Internal revenue Code 280E, high regulatory costs, and unaffordable or unavailable insurance coverage. As more prospective business owners get really serious about their business plans, they should consult with an attorney and CPA who can oftentimes find creative solutions to help mitigate the impact of these barriers.”

 Other Noteworthy News

Salem, Massachusetts Lawmakers Vote to Decriminalize Psilocybin Mushrooms
“Salem, Massachusetts lawmakers have approved a resolution to decriminalize psilocybin mushrooms. Members of the City Council voted unanimously on Thursday [5/11/23] to pass an activist-led measure making it the local government’s official policy to deprioritize enforcement of laws prohibiting the possession and cultivation of psilocybin. This is the latest Massachusetts city to enact some form of psychedelics decriminalization as the national reform movement continues to expand, though it is the only one to focus on psilocybin alone. Other cities that have taken broader psychedelics action include Somerville, Cambridge, Easthampton and Northampton. The local measure doesn’t remove criminal penalties for the substance, but it states that the “arrest of adult persons for using or possessing psilocybin-containing fungi” as well as the “investigation and arrest of adult persons for cultivating, purchasing, transporting, distributing, engaging in practices with, and/or possessing psilocybin-containing fungi” should be “amongst the lowest law enforcement priority for the city of Salem.” The resolution says that “no City of Salem department, agency, board, commission, officer or employee of the city should use city funds or resources to assist in the enforcement of laws imposing criminal penalties for the use and possession of psilocybin-containing fungi by adults.”
State to Fund Clinical Trials on "Whole Mushroom" Psilocybin Research
“Arizona will soon award $5 million in grants for researchers to conduct clinical studies on hallucinogenic psilocybin mushrooms. The recently approved budget for fiscal year 2024 includes a competitive grant program overseen by the Arizona Department of Health Services (ADHS). Grant recipients will conduct clinical trials to study the effects of "whole mushroom psilocybin" on post-traumatic stress disorder, long COVID symptoms, depression, anxiety, chronic pain and other maladies. Trials must prioritize veterans, first responders, frontline health care workers and people from underserved communities. It's unclear when ADHS will begin accepting applications or how large the grants will be, but the budget requires that grants be awarded by Feb. 1 each year.”
Psychiatrist to Lead State-Mandated Psilocybin Trial
“UW Medicine will facilitate a small-scale study to explore the potential benefit of psychedelic mushrooms with psychotherapy. In early May, Washington Gov. Jay Inslee signed Senate Bill 5263 governing recreational and medical use of psilocybin. The new law mandates that the University of Washington School of Medicine facilitate a study to explore the potential therapeutic value of the psychedelic compound found in mushrooms. “The big benchmark in the bill says that we need to start (treating) people Jan. 1, 2025. We have about a year and a half to get all the infrastructure developed,” said addiction psychiatrist Dr. Nathan Sackett, who will oversee the trial. He’s an acting assistant professor of psychiatry and behavioral sciences. Sackett said the Seattle-based trial will include 30 to 40 military veterans and first-responders who have documented problems with post-traumatic stress and alcohol use disorders, which are often linked. Participants will likely be recruited through community groups who already work with prospective participants.”
VIDEO: Touring Oregon's First Licensed Psilocybin Lab
“It's been two years in the making, but Oregon now has the supply chain for legal psilocybin therapy complete from cap to stem. That means that the state has licensed at least one "magic mushroom" grower, a lab to test the product, facilitators to administer the psilocybin to clients and a service center to do it in. Recently, The Story got a chance to tour Rose City Laboratories, which is the first lab licensed in Oregon to test psilocybin. They walked [KGW8] through the process that happens before psilocybin gets sent out to service centers for clients to take in controlled "trips."
L.A. Dispensaries Openly Sell ‘Magic Mushrooms’ as State Weighs Decriminalization
“As the state Legislature considers a bill to decriminalize several psychedelics including psilocybin, some L.A.-area businesses are openly selling the potent hallucinogen. Although cannabis is legal statewide, no Southern California municipality or county has followed the lead of Oakland, San Francisco and Santa Cruz by decriminalizing magic mushrooms. Yet there’s a thriving market for the fungi and other psychedelics in L.A. Entrepreneurs have long taken advantage of the relative scarcity and high demand by selling them illegally, in gleaming storefronts and in parking lots. The L.A. County Sheriff’s Department served about 50 search warrants at dispensaries selling magic mushrooms in the last six months alone. Meanwhile, there’s growing support for legalizing or decriminalizing psilocybin and other hallucinogens among psychologists, researchers, veterans’ advocates and others who’ve witnessed mental health turnarounds after psychedelic treatment. As evidence of their therapeutic benefits grows and states including Oregon and Colorado legalize or decriminalize magic mushrooms, some Democrats in Sacramento are pushing to make a similar change in California.”

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PsychedeLinks – May 12, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

Oregon Approves First Psilocybin Service Center License
Nearly three years after voters approved Measure 109, which made Oregon the first state in the country to legalize psilocybin, on Friday the Oregon Psilocybin Services section issued the first service center license - to EPIC Healing Eugene, owned by Cathy Jonas. Once licensed, service centers can employ and/or contract with licensed facilitators who are trained in providing preparation, administration, and integration sessions to clients. Service centers will sell psilocybin products that were produced by licensed manufacturers and tested by licensed laboratories. Clients 21 years of age or older may access psilocybin services, and while they won’t need prescriptions or referrals from healthcare providers, they must first complete a preparation session with a licensed facilitator.

If they meet the criteria to move forward, they may participate in an administration session at a licensed service center, where they may consume psilocybin products in the presence of a trained and licensed facilitator.

“Oregon has now issued at least one Service Center, Manufacturer, Laboratory, and Facilitator license, and almost 100 worker permits, all of the license types under the newly created program. While the process was not free from controversy, this approval represents the culmination of years of cooperative work by government, businesses, and the public,” said Emerge’s Matt Brockmeier. “It’s also instructive as other states, like Colorado, are also creating similar regulatory schemes. Psychedelic decriminalization efforts are gaining momentum around the country, and states like Oregon and soon Colorado can provide a helpful model for other states.”

 Other Noteworthy News

Ohio State Receives DEA license to Grow Psychedelic Mushrooms for Research
“The DEA has issued a license to Ohio State University that will allow the school to legally cultivate psilocybin mushrooms. This is reported to be the first such license issued to a university research center, and will allow Ohio State and its partner, Inner State, to cultivate psilocybin mushrooms for research purposes only. This development comes after the Center for Psychedelic Drug Research and Education (CPDRE) Directed by Assistant Professor of Social Work Alan Davis was established at Ohio State last year.

All research will be conducted in a federally sanctioned and secured grow house in accordance with strict DEA regulations and guidelines. “By combining cutting-edge techniques in genomics and metabolomics, we have the opportunity to obtain a high-resolution picture of the chemical diversity of mushrooms that have remained difficult to study for several decades,” according to Ohio State researchers Dr. Jason Slot and Dr. Kou-San Ju.”
Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
“On May 10, DEA issued a new regulation temporarily extending waivers used during the COVID Public Health Emergency (PHE) to ensure patients did not experience lapses in care, and to ensure continuity of care under the current telehealth flexibilities. Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, a practitioner was required to conduct at least one in-person medical evaluation of the patient before prescribing a controlled substance by means of the “Internet” (a broadly defined term that includes telemedicine). The Ryan Haight Act contains seven “practice of telemedicine” exceptions to the in-person medical evaluation requirement, one of which was used by DEA to extend COVID-19 PHE DEA telemedicine flexibilities through November 11, 2023. This additional time is intended to allow patients, practitioners, pharmacists, service providers, and other stakeholders sufficient time to prepare for the implementation of any future regulations that apply to prescribing of controlled medications via telemedicine. It will also give DEA time to review and respond to the 38,369 comments they received in response to the two notices of proposed rulemaking and to conduct a thorough evaluation of regulatory alternatives in terms of telehealth rules.”
Kaya, Jamaican Cannabis Operator, Introduces Psychedelic Mushroom Chocolate
“Kaya announced today its Kaya Extracts subsidiary plans to expand its product offerings in Jamaica's legal psilocybin market by introducing two new SKUs of Psychedelic Mushroom Chocolate. Kaya will sell its Psychedelic Mushroom Chocolate in a flat bar that contains 1000mg of psilocybin per bar that can be broken into four equal-sized pieces containing 250mg of psilocybin per square. Each square can be divided into smaller, fractional pieces for a scheduled psilocybin microdose routine. Kaya Group ("Kaya") also recently announced plans to expand its already profitable Jamaican operations. Jamaica is emerging as a destination for psychedelic travelers, as Jamaica does not have any regulations on the cultivation of psilocybin mushrooms at the moment.”

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PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.
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PsychedeLinks – May 1, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

Oregon Approves Nation’s First Psilocybin Facilitator Licenses to Administer Psychedelic
As of May 1, the Oregon Health Authority (OHA) has issued 3 manufacturer licenses, 1 laboratory license, and 5 facilitator licenses. First and foremost, congratulations to the newly licensed laboratory and facilitators! However, it remains to be seen when the OHA will issue the first service center license(s), and the business models that those first service centers have in mind. “To keep costs affordable and psilocybin services accessible to a wide variety of people, we need a wealth of service center business models ranging from microdosing, to no-frills single room sessions, to more comprehensive resort-style options,” says Emerge attorney, Kaci Hohmann. “If regulated businesses can’t pass on rates to clients that compete with the underground, then the program simply won’t meet its intention to provide affordable access to the public. That would be a real failure and one I hope will be avoided as service centers come online in the coming months and years.”

 Other Noteworthy News

Colorado House Approves Senate-Passed Psychedelics Regulation Bill
“The Colorado House of Representatives approved a Senate-passed bill to create a regulatory framework for legal psychedelics under a voter-approved initiative. The legislation seeks to set policies on “healing centers” where adults 21 and older could receive psychedelic treatment, tighten up rules on cultivation and facilitators, establish licensing requirements, dictate state agency regulatory responsibilities and impose penalties for unsanctioned activities. During Thursday’s House Finance Committee hearing, members adopted a series of amendments, including adding language to clarify that using psychedelics would not be a violation of probation or parole[.] Another adopted amendment makes various changes, including: requiring psychedelic facilitators to inform participants if they are not licensed; making it so psychedelics business employees have to comply with the state’s general fingerprinting rules for practitioners; clarifying that protections for parental rights of people who use psychedelics are limited in cases where the health and safety of a child is threatened; and making changes to definitions of psychedelic business entities that were requested by municipal officials. On the floor on Friday, members adopted additional amendments to clarify that personal cultivation of psychedelics can be done outside of a residence (such as in a greenhouse) as long as it is on someone’s own property in an enclosed and locked space, direct regulators to collect data on drug use trends, require regulators develop an equity plan and define federally recognized tribes cited in the bill. The body also rejected several amendments, including ones that would have given local officials authority to further restrict psychedelic services, required businesses to have liability insurance policies, added progesterone to the definition of natural medicines being legalized and regulated under the bill, included pregnancy resource centers in the definition of healing center while exempting them from licensing requirements and removed the phrase “or related services” from the definition of personal use.”
US Could Soon Approve MDMA Therapy – Opening an Era of Psychedelic Medicine
“For Rick Doblin, 2023 could be a landmark year: the year that the US government decides whether it will allow the use of hallucinogenic drugs to treat mental illness. Doblin…is the founder and president of the non-profit organization Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS has now completed a second, larger trial that it says has also produced positive results. After that study is published in the coming months, MAPS plans to ask the US Food and Drug Administration (FDA) to approve the drug as a legal treatment for PTSD, probably by October. But many questions remain in the short term, chiefly how MDMA will be administered and by whom. MAPS officials say that the drug must be given in concert with a psychotherapy protocol developed by the company’s scientists, but the FDA does not typically regulate such treatments. Some worry that premature approval of the drugs could frustrate scientific progress. In 2020, the state of Oregon voted to legalize psilocybin for therapeutic use. And in February, researchers around the world were shocked when Australia’s Therapeutic Goods Administration announced that it would legalize MDMA as a PTSD treatment as of 1 July. Australia’s move could put pressure on the FDA to approve MDMA and open a larger market in the United States. MAPS intends to commercialize MDMA for profit, but its long-term plans are unclear. In 2014, the organization created a public-benefit corporation (PBC) — a company that attempts to balance shareholders’ financial interests and the public interest. Beyond that, Doblin says, MAPS PBC hasn’t decided what its future will look like. “I’m on the knife’s edge between capitalism and altruism,” Doblin says.”
MindMed Collaborators Announce Positive Phase II Results for LSD in Major Depressive Disorder
“NYC-based clinical-stage biopharmaceutical company Mind Medicine (MindMed) announced that Swiss collaborators at the University Hospital Basel (UHB) and the University Hospital of Psychiatry have released positive topline data from a double-blind, investigator-initiated trial evaluating lysergide in the treatment of major depressive disorder (MDD). A few years back, MindMed entered into a pretty broad research collaboration with Matthias Liechti, MD, PhD, at the University Hospital Basel. As part of the collaboration between MindMed and Liechti, a number of investigator-initiated studies have been and are being conducted with lysergide. The Phase II study, led by Liechti and Felix Mueller, MD, consisted of 61 patients with MDD given two doses of lysergide four weeks apart. A high-dose group received doses of 100 μg on day zero and 200 μg on day 28, and a low-dose group received 25 μg on both days, which is about the perceptual threshold for lysergide, according to Barrow. Consistent with a long history of positive results in hundreds of patients in over 20 studies, lysergide showed significant, rapid, and beneficial effects, as well as the potential to alleviate MDD symptoms. The Swiss collaborators saw a clinically and statistically significant response for the primary endpoint: a statistically significant 12.9-point reduction in the high-dose group versus a 3.6 reduction in the low-dose group.”
Executive Behind Chat GPT Pushes for a New Revolution: Psychedelics
“Sam Altman, chief executive of OpenAI, is chairman of a start-up that aims to tap into the promise that psychedelic drugs have shown in clinical trials — and make them broadly available for people who suffer from mental health and drug-use disorders. The firm, Journey Colab, is partnering with a luxury rehab clinic, All Points North, to shepherd drugs like MDMA and psilocybin through late-stage trials and design a model for administering them to patients. Altman’s foray into psychedelics showcases the buzz that the drugs have kindled in Silicon Valley, with venture capitalists betting millions of dollars that such therapies will transform treatment for mental health disorders and drug addiction. He is entrusting the details of this to Chowdhury, a Rhodes scholar and physician-turned-entrepreneur, who came to psychedelics through his own mental health struggles and credits them with saving his life. Chowdhury freely acknowledges that he doesn’t yet have a business model, but envisions Journey becoming a specialty service, providing psychedelic care to patients at rehab clinics the way wound-care specialists are contracted by hospitals. To begin with, he said, Journey is working to partner with firms conducting clinical trials on MDMA and psilocybin to run them at a rehab center near Vail, Colo. Journey Colab has emphasized making psychedelic therapy accessible to marginalized communities — it has reserved 10 percent of its founding equity in a trust to benefit U.S. Indigenous groups — but is first focused on delivering the care with all of the supports available in a facility like All Points North.”

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PsychedeLinks – April 14, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

This Psychoactive Plant Could Save Lives—And Everyone Wants To Cash In
Tabernanthe iboga is a tree whose roots contain a powerful psychoactive compound called ibogaine. It is native to several Central African countries but is most culturally established in Gabon. Studies have shown that ibogaine, which takes its name from the tsogho word “to heal,” can prompt significant decreases in PTSD symptoms. But ibogaine also has risks. It can strain the kidneys and liver, although deaths are usually attributed to its effect on the heart. And behind the flood of positive stories about changed and saved lives hides an embarrassing truth: the iboga and ibogaine used by clinics around the world originate largely from plants poached illegally. That’s because iboga is subject to the Nagoya Protocol, a United Nations agreement designed to prevent cultural and natural exploitation by establishing a sharing of benefits benefiting producers of genetic resources and their environment. The first iboga to be legally exported from Gabon just left the country, bound for researchers and clinics in Canada and Mexico. “We have never refused to share iboga with others,” said Denis Massande, president of the Association for the Development of Culture of the Pygmy Peoples of Gabon. “But now that this iboga business has gained notoriety around the world, if you don't put regulation in place, iboga will disappear.”

“Colorado legalized the personal use of iboga under the Natural Medicine Health Act, and given its apparent therapeutic potential I would expect other states to follow suit.” said Emerge Law Group’s Matt Brockmeier. “But it’s important to balance access with other concerns, like the rights of indigenous communities where iboga is sourced, as well as safety, considering the associated health risks, which are not just a ‘bad trip’ but potential cardiac complications.”

 Other Noteworthy News

Beyond Medical Marijuana, A Bipartisan Group Of NC Legislators Wants To Study Psychedelics
“For a relatively conservative Southern state that has yet to legalize cannabis, most conversations about psychedelics don’t mention North Carolina. But that hasn’t stopped State Rep. John Autry, a Mecklenburg County Democrat, from working to advance research on psychedelics. He and other members of the North Carolina legislature formed the NC Psychedelic Policy Coalition and are supporting a proposal to allocate $4.5 million to support two psychedelic medical studies conducted by North Carolina’s research universities. A proposed psilocybin study would focus on reducing anxiety and fear in people with cancer and other life-threatening illnesses. A separate MDMA study would focus on reducing post-traumatic stress disorder (PTSD) experienced by veterans, first responders and sexual assault survivors. The legislation would also create an advisory board of experts to make recommendations about how these medicines can responsibly be made more available in North Carolina. Notably, the bill would not make psychedelics available for retail purchase. But home to the Research Triangle and two world class universities, the Tar Heel State may begin allowing its citizens to heal with psychedelics sooner than expected.”
3,000-Year-Old Hairs Hold the Oldest Clues About Psychoactive Drug Use in Europe
“Drug use among humans is a practice known to be thousands of years old, based on clues that were previously uncovered in Eurasia and the Americas. But in Europe, the presence of mind-altering plants at prehistoric sites offered archaeologists an incomplete picture; until now. Scientists recently discovered direct evidence that people in Europe used psychoactive drugs during the Bronze Age, possibly as part of ancient rituals. Traces of alkaloid substances that originate in plants and are known to affect perception and cause delirium and euphoria were preserved in strands of human hair dating to around 3,000 years ago. The compounds that they detected are all produced by plants that grow on Menorca, such as devil’s snare (Datura stramonium), white henbane (Hyoscyamus albus), mandrake (Mandragora automnalis) and joint pine (Ephedra fragilis).”
Hawaii Passes Bill to Prepare for Federal Approval of Psychedelics
“The Hawaii Senate just approved HB1340, a proposed bill that would create an advisory board to explore and prepare for regulations around federal approval of “breakthrough therapies” like psychedelics. It would create an advisory council tasked with exploring state and federal regulations on certain psychedelics, in addition to reviewing scientific literature related to using them for mental health treatment. It would also assess FDA breakthrough therapies and examine the requirements, specifications, and guidelines for a health care professional to prescribe and provide various treatments for patients who may benefit. The The bill passed the Senate on April 11 without much debate, and is now headed to the House for another - perhaps final - vote.”

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PsychedeLinks – March 31, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

Medford Company Becomes Second in State to Receive Psilocybin License
In the past week, the Oregon Health Authority issued Oregon’s first two psilocybin manufacturing licenses to Satori Farms PDX and Satya Therapeutics. Next up, the OHA expects to soon issue licenses to facilitators, service centers, and laboratories. But will psilocybin services be in full swing imminently? Probably not. The full psilocybin mushroom growth cycle can take a couple months and a laboratory still needs to be licensed by the OHA to test the first batch of psilocybin mushrooms before the product can make its way to services centers and ultimately consumers. “As we suspected and have reported in the past, the Oregon psilocybin services program is slow to grow but based on the concerns being voiced, I remain hopeful that people in this space are committed to building an affordable and sustainable program,” says Emerge attorney Kaci Hohmann. Patience…it’s a virtue.

 Other Noteworthy News

Market Battle Lines are Being Drawn in Psychedelics – But What are the Warring Camps Really Fighting About?
“Advocates are understandably concerned that patents will be used to withhold medicine from people who need it. If these biotech businesses try to be rent-seekers of the entire industry, it will go about as well for them as it’s gone for corporate cannabis. Despite their mutual antipathy, I would argue that cultivators making small-batch chocolates and billion-dollar corporate entities do actually have something in common: they’re all incentivized to paint psychedelics as a miracle cure-all. Psychedelics’ potential is genuinely awe-inspiring — but as a long-time supplement manufacturer, I can assure you there are no magic bullets for physical or mental health. These psychoactive compounds are tools for change, not the change itself — and overstating their capabilities does consumers a disservice. When Oregon legalized recreational psilocybin use but required it to be consumed with a licensed guide, critics accused them of gatekeeping — but psychiatrist Richard A. Friedman applauded the choice. “Reshaping your mind isn’t always a great idea,” he argued in a recent Atlantic piece titled ‘Psychedelics Open Your Brain. You Might Not Like What Falls In.’ Clearly, big businesses shouldn’t be allowed to “own” plant medicines that have been used for millennia. But reasonable people with honorable motives can differ on some of these other issues, from regulating therapeutic training standards to what we should teach consumers to expect from psychedelic experiences. We can rail against the corporate water that’s flooding the psychedelic ship — or we can all grab a bucket and start bailing. We can also model responsibility in this space by not overpromising on psychedelics or misleading consumers into thinking they’re a magic antidote to all that ails us.”
Field Trip’s Downfall: Too Early, Too Aggressive, Too Extravagant?
“From the get-go, Field Trip made it clear that they would pursue an aggressive growth strategy, planning to open seventy-five clinics by 2024. But, there’s the kicker: Field Trip’s services were out of pocket, there was no reimbursement from insurance companies. There’s a limited pool of folks that would be able to afford Field Trip’s treatments, then. Self-styled psychedelic clinics like Field Trip were also a bit off in their forecasts of when psychedelics like MDMA and psilocybin might be approved. This confluence of factors has been punctuated by a cooled-off market that’s seen a significantly increased cost of capital. To be honest, Field Trip’s remarkable fundraising stint will likely be viewed in hindsight as an artefact of a frothy, hype-fueled early psychedelics market.”
Some Colorado Communities Don’t Want Psychedelic Healing Centers – But Can They Stop Them?
““Proposition 122 specifically prohibits local bans,” said state Sen. Steve Fenberg, a Boulder Democrat and the Senate president. “So a municipality can’t ban — but it can regulate time, place and manner.” Despite the ballot measure’s explicit prohibition on local opt-outs on psilocybin healing centers, municipal and county leaders from the Kansas line to the Utah line are intent on inserting as much local control as they can into whatever psychedelics-related legislation emerges at the state House this spring. The refrain at the Colorado Municipal League’s annual legislative workshop in Denver in February was clear: regulate mushrooms like marijuana. “Colorado has established a precedent with marijuana that allows Colorado communities to choose whether, and to what degree, they want to allow controlled substances in their communities,” league executive director Kevin Bommer said. “That precedent has been working well for state and local governments, but Prop 122 deviates from this model.” The jostling over the introduction of magic mushrooms is just the latest clash in a long-running dispute over what power and authority belongs to Colorado’s cities and counties versus the state. Cokedale Trustee Bob Holman said there are many specialty healthcare services that are simply not available to residents in rural areas of the state and psychedelics shouldn’t get special status. But backers of Prop 122 are adamant that their measure not get watered down. In February, proponents of psychedelic medicine faced off with state lawmakers in a legislative town hall in Boulder to demand that the General Assembly not gut the spirit of what voters passed.”
Hawaii Health Department Says Legalizing Psychedelics Is a ‘More Meaningful’ Step Than Creating a Study Group
“The Hawaii Department of Health (DOH) says that it would be prudent for the state to legalize certain psychedelics like psilocybin and MDMA to prepare for a likely federal policy change allowing their use for medical treatment. At a hearing before the Senate Health and Human Services Committee last week, DOH testified on a pair of resolutions that call for the establishment of an advisory council to study and make recommendations on approving psychedelic medicines. Members of the panel ultimately deferred action on the legislation, but there are other psychedelics bills advancing in the legislature this session, including one to create an advisory council to look into possible regulations to provide access to federal “breakthrough therapies” like psilocybin and MDMA. During last week’s Senate hearing, a DOH representative said that the department is neutral on the separate resolutions being considered by the committee, adding that he didn’t think the department would be the appropriate body to oversee the proposed advisory council. He also said that it might not necessarily make sense to form such a council to advise on possible therapeutic uses for psilocybin and MDMA given that the federal Food and Drug Administration (FDA) seems poised to authorize their use within “half a year” after designating them as “breakthrough therapies.”

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PsychedeLinks – March 17, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

Oregon Closer to Magic Mushroom Therapy, But Has Setback
Last week, more than 100 future Oregon facilitators graduated from InnerTrek’s psilocybin facilitator training program. Congrats to those students! Soon enough those facilitators will be licensed by the Oregon Health Authority (OHA) and ready to provide psilocybin services to clients. But without any currently licensed OHA services centers or manufacturers, there are no clients for facilitators to guide and no psilocybin products to administer. It’s a classic chicken and egg scenario. It isn’t clear yet how many service centers will be licensed and operational by the end of the year and many facilitators may be without a job for longer than initially anticipated. “The service center to facilitator ratio may be out of whack for quite some time. So, facilitators will be forced to wait it out, apply for service center licenses of their own to address the bottleneck, or maybe even turn (or return) to the underground,” says Emerge attorney Kaci Hohmann.

 Other Noteworthy News

Psychedelics Could Revolutionize Couples Therapy
“Proponents of psychedelic use expect the U.S. Food and Drug Administration (FDA) to approve MDMA as a treatment for post-traumatic stress disorder (PTSD) within the next two years. If that happens, it could potentially open the door to other therapeutic uses of the drug—possibly including couples therapy. Research on MDMA in couples therapy is limited, but the practice has a long history. Some therapists legally used MDMA in couples counseling in the 1970s and 1980s. Effective as they can be, though, experts say it’s a mistake to think that psychedelics offer a one-way ticket to marital bliss.”
Vermont Legislators File Four Bills that Would Legalize Psychedelics and Decriminalize All Drugs
“Four major drug reform bills have been introduced in the Vermont State Legislature to decriminalize simple possession of all drugs, expand harm reduction services, remove criminal penalties for using and selling psilocybin and decriminalize certain psychedelic plants and fungi. Nearly a third of their 150-member House of Representatives have co-sponsored H.423, an all-drug decriminalization legislation sponsored by Reps. Logan Nicoll (D) and Taylor Small (P/D). Rep. Vyhovsky (P/D) has joined forces with ten other senators on the S.119 companion bill, making Vermont on its way to becoming the promised psychedelics land. H.439, sponsored by Rep. Brian Cina (P/D), would completely decriminalize psilocybin, mescaline and peyote in Vermont by removing them from Vermont's definition of hallucinogenic drugs. S.114 ,the other proposed bill by Sen. Martine Gulick (D) would not only remove the famed psilocybin mushroom from Vermont's drug classification, but also take an entire step above her colleague's effort to create a working group dedicated to studying the potential physical and mental health benefits of these substances. The specific psilocybin bill has been assigned to the Senate Health and Welfare Committee for deliberation, while all other related bills have been referred to their respective chamber's judiciary committee.”
Washington Senate Approves Scaled-Down Psilocybin Bill to Prepare State for Future Psychedelic Services
“The Washington State Senate has approved a bill to create a task force promoting research into psilocybin and developing a pathway for legal access to the psychedelic.
The legislation from Sen. Jesse Salomon (D)—which was effectively gutted in an earlier Senate committee to exclude original regulated access provisions—cleared the full chamber in a 41-7 vote on Tuesday. It now heads to the House. Senate Democrats cheered the passage, but advocates remain disappointed about the extent to which the bill was watered down in committee. That 81-page bill was reduced to an eight-page bill mandating the formation of a task force to explore regulatory pathways for the psychedelic in the future. It’s possible, of course, that House lawmakers may seek to further amend it in their chamber.”
Colorado’s Proposition 122: Too Soon for the Mushroom Boom?
“Is Colorado's passage of Prop. 122 a bridge too far for federal law enforcement? We have yet to see what the federal government's enforcement position will be with regard to legalizing magic mushrooms, much less DMT or Mescaline. Will the Department of Justice sit back and allow states to continue to legalize other Schedule 1 Controlled Substances without some federal interference? Alternatively, will Merrick Garland's Department of Justice issue a "mushroom memorandum" akin to the now-rescinded Cole Memorandum of 2013 for cannabis? As they say, history is often bound to be repeated. While Psilocybin may have a faster federal legalization trajectory than cannabis has, Colorado is wise to create a robust regulatory framework to stave off possible federal enforcement of the Controlled Substances Act. Industry participants need to understand the potential risks, and armed with a hefty dose of risk tolerance, seriously address compliance with state law. Is it too soon for a mushroom boom? We will have to wait and see.”
Vancouver Company Inks MDMA and Psilocybin Distribution Agreement in Australia
“Vancouver-based drug manufacturer and formulator Optimi Health has signed a distribution agreement to supply the Australian market with its MDMA formulation and psilocybin capsules. The products will be exported to Australia by July 1, 2023, when authorized psychiatrists can begin prescribing MDMA and psilocybin for specific mental health conditions. The distribution agreement is with Mind Medicine Australia (MMA), a leading charitable organization and patient advocacy group seeking to expand access to legal psychedelic-assisted therapies, and marks Optimi Health’s first international MDMA and psilocybin sale. All products destined for the Australian market will be manufactured, encapsulated and packaged inside Optimi’s facility under GMP-compliant protocols, and will follow Health Canada’s controlled substances export laws. To provide equitable access to its products, Optimi will allocate a percentage of product sales towards a fund managed by MMA to assist low-income earners and others who face systemic barriers to access, with those details to be announced in the coming weeks.”

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PsychedeLinks – March 3, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

DEA Proposes New Telemedicine Regulations
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) amended the Controlled Substances Act (CSA) in an attempt to prevent the illegal distribution of controlled substances on the internet. Among other things, the Act required an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances online. One exception allowed DEA to waive the in-person requirement during the COVID Public Health Emergency (PHE). During the pandemic a number of companies began providing a not insignificant volume of controlled substances via telehealth, namely ketamine and Adderall, subject to this exception. However, that exception is set to expire on May 11, 2023, thrusting a nascent industry into uncertainty over the past few months. Analysts familiar with DEA’s intransigence and stall tactics predicted that the ketamine telehealth industry would be devastated by the expiration of the PHE declaration. In a surprise to most, on March 1, 2023, DEA issued a notice of rulemaking that would authorize telemedicine where 1) the prescribing practitioner has not conducted an in-person medical evaluation with the patient; 2) the prescription was issued pursuant to a telemedicine encounter and 3) the telemedicine encounter results in a prescription for controlled medications. There are some limitations, including that prescribing practitioners will only be able to issue telehealth prescriptions for up to a 30-day supply of a controlled substance, and there are labeling and recordkeeping requirements. Some telehealth providers and advocates have concerns about some of the limitations in the DEA’s proposed rules, but for ketamine in general, “this is an encouraging development from an agency that has earned a reputation for being dilatory and obstructionist at times”, says Emerge Of Counsel attorney, Matt Brockmeier.

 Other Noteworthy News

Bill Seeks Personal Data Collection On People Who Use Legal Psilocybin in Oregon
“State Sen. Elizabeth Steiner, D-Portland, wants the state to monitor whether Oregon’s landmark law allowing the controlled use of psilocybin is working as intended — and not just for ‘rich white people.’ The Oregon Senate Health Committee on Monday heard her bill, Senate Bill 303, which would require psilocybin service centers to collect data on the health, education, race, income and other sensitive information of adults that use the hallucinogenic drug under their supervision. Steiner’s bill is in response to concerns that Oregon’s psilocybin program will only be accessible to those who can afford what could be hefty price tags service centers charge. It’s also meant to answer questions about the effectiveness of the first-of-its-kind program, which was pitched to voters as a means to address mental health and included a requirement that a report be issued on safety and efficacy after the first two years. Opponents of the bill argue it will mean another administrative burden that will further drive up the cost of psilocybin sessions. They also say its data collection requirement will have a chilling effect on people who may already be wary of using the federally illegal drug for its purported benefits.”
New Mexico Lawmakers Approve Psilocybin Study Bill
“New Mexico lawmakers advanced legislation on Wednesday to create a state body that would study the possibility of launching a psilocybin therapy program for patients with certain mental health conditions who could benefit from using the psychedelic. The House Health and Human Services approved the bill, sponsored by Rep. Christine Trujillo (D), in a unanimous voice vote. The measure now heads to the House Appropriations & Finance Committee. The legislation would establish an eight-member Psilocybin Advisory Group appointed by the governor that would be responsible for studying and making recommendations on the ‘feasibility’ of creating a psilocybin therapy program. Members would specifically need to consider policies to create a regulatory framework for psilocybin cultivation, manufacturing and dispensing, as well as ‘treatment guidelines for the use of psilocybin-derived products to treat certain mental health issues, including patient selection and provider training and certification.’”
More and More Psychedelic Reform Bills in the Pipeline Throughout United States
“2023 has already shown extensive advances in the realm of psychedelic policy reform. About a dozen states in the US have put forward legislation that would see multiple psychedelic substances from ketamine, MDMA, psilocybin, and more receive downgraded criminalization designations. In addition, lawmakers are as open as ever to the idea of psychedelics’ therapeutic potential. Special task forces or state-sponsored research bodies have been created or are set to be voted on which would seek to properly educate voters and state governing bodies on the possibilities associated with psychedelic therapy. With direct support from the Governor’s office, two new psychedelic research bills have been unanimously approved by Hawaii’s Senate Ways & Means Committee. While not exactly psychedelic policy, an important bill is brewing in Colorado’s state legislature. It would allow cities throughout the state to institute “overdose prevention centers”, similar to those seen in Europe, where citizens could use drugs regardless of their legality in a medically supervised environment.”
Untangling Anorexia: Psychedelics Offer Hope for a Neglected Condition
“Characterised by self-starvation, anorexia nervosa is a psychiatric disorder that mainly affects adolescent women, who become invested in restricting their food intake. A fear of weight gain can morph into a general fear of loss of control. In the past, clinicians have looked to pharmaceuticals for help, but several antidepressants, antipsychotics and nutritional or hormonal supplements have failed in clinical trials[4]. As a result, no medicine has been licensed. Another approach attempts to reset the outlook of a person with anorexia nervosa with psychedelics. Several clinical trials of psilocybin — the active ingredient in magic mushrooms — are underway. ‘If you experience that you can still have life, that you can still have hope, this helps to motivate the patient for further therapy,’ says Hubertus Himmerich, a clinician and researcher at King’s College London, who is leading a trial of psilocybin for anorexia, using ‘COMP360’ tablets of synthesized psilocybin manufactured by COMPASS Pathways. Two other trials of psilocybin therapy for anorexia nervosa are also ongoing.”

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PsychedeLinks – February 17, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

Lawmakers Could Limit Personal Psychedelic Rights Created by Prop 122
There’s been chatter coming from Colorado this week that lawmakers will move forward this session with legislation restricting the Natural Medicine Health Act (“NMHA”). The NMHA is a rather broad act with a decriminalization element allowing personal use, possession, cultivation, and adult sharing of five psychedelic medicines (psilocybin, psilocin, mescaline (excluding peyote), DMT, and iboga), and a regulated element allowing adult consumption at state-licensed healing centers. At a Boulder town hall meeting on February 13, 2023, Colorado Senator Steve Fenberg confirmed the Colorado legislature will consider specific limitations on cultivation, possession, and transportation restrictions for the decriminalization component of the NMHA. Other groups in Colorado are lobbying for local jurisdiction approval of cultivation and healing centers. Colorado is home to a growing and vibrant community of advocates and activists who are working tirelessly to ensure the healing potential of these medicines is fully realized. “In the months before the election, psilocybin advocates who supported decriminalization before commercialization voiced concerns that legislators would water down the hard-won ‘personal use’ provisions. It appears those fears have just been substantiated. It would be paternalistic and antidemocratic for legislators to defy constituents by substantially modifying the law at this point,” says Matt Brockmeier, Of Counsel Attorney at Emerge Law Group.

 Other Noteworthy News

Australian Approval of MDMA and Psilocybin a ‘Baby Step in the Right Direction’, Medical Experts Say
“The Therapeutic Goods Administration announced on Friday that, from July, approved psychiatrists would be able to prescribe MDMA (ecstasy) for post-traumatic stress disorder and psilocybin (found in magic mushrooms) for treatment-resistant depression. The move makes Australia the first country in the world to officially recognize psychedelics as medicines. Psychiatrists will need to get approval by a human research ethics committee, then approval under the TGA’s authorized prescriber scheme. To get those approvals they must demonstrate their training, robust patient selection and evidence-based treatment protocols, as well as patient monitoring. They must also satisfy governance and reporting criteria. Because there are are currently no approved Australian substances, the psychiatrist would also have to apply for a license to import them.”
Psychedelics May Be Part of U.S. Medicine Sooner Than You Think
“In Nov. 2022, the U.S. nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that it had completed a second phase-three trial on MDMA as a treatment for PTSD—a step widely seen as the last hurdle to clear before applying for approval from the U.S. Food and Drug Administration (FDA). Rick Doblin, MAPS’ founder and executive director, says his group is preparing to apply for FDA approval based on those data. If all goes well, he says, the drug could be approved as soon as 2024. Australia’s approval of these drugs, Doblin says, may only expedite the approval process in the U.S. A representative for the FDA did not respond to TIME’s request for comment before press time. But in a May 2022 letter first published by the Intercept, a U.S. Department of Health and Human Services official wrote that FDA approval of MDMA and psilocybin was ‘anticipated’ within ‘approximately 24 months.’”
Arizona Lawmakers Unanimously Approve Bipartisan Psilocybin Research Bill
“Arizona lawmakers have approved a bill in committee to promote research into the medical potential of psilocybin mushrooms for a variety of conditions, which could inform future reforms to more broadly allow access to psychedelic-assisted therapy. The proposal is focused on psilocybin research, providing $30 million in grants over the course of three years for scientists to study the impact of the psychedelic on 13 different conditions such as post-traumatic stress disorder (PTSD), depression, anxiety, long COVID symptoms and substance misuse disorder. The research grants would be appropriated for phase I, II and III clinical trials that are “capable of being approved by the United States Food and Drug Administration (FDA) to evaluate the effects of whole mushroom psilocybin” for the designated conditions. A “Psilocybin Research Advisory Council” would be established under the Department of Health Services (DHS), tasked with establishing eligibility criteria for grant recipients, overseeing applications and making “recommendations to the governor, the speaker of the House of Representatives, the president of the Senate and the department on psychedelic-assisted therapy based on current federal and state research policy.”
Senator Pivots to Pilot Program to Legalize ‘Magic Mushrooms’ in Utah
“A lawmaker is paring down her plan to decriminalize magic mushrooms in Utah for patients suffering from certain conditions. Senate Bill 200, sponsored by Sen. Luz Escamilla (D-Salt Lake City), now aims to create a pilot program for patients to use psilocybin. She hopes that change might move it across the finish line. Escamilla’s plan would allow patients suffering from depression, anxiety, PTSD, or those on hospice care to use psilocybin. But it would cap the number of patients at 5,000. ‘This will be under a lot of control,’ said Escamilla. Her bill would also impose an end date to the pilot program so the Legislature can review it.”

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PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.
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PsychedeLinks – February 3, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

Regulatory Hurdles Challenge Oregon Psilocybin Providers
Emerge attorneys, Dave Kopilak and Kaci Hohmann, are quoted in this Lucid News article along with other key individuals in the Oregon psilocybin services world. Ranging from insurance to land use to business realities, the article touches on the primary legal concerns facing prospective psilocybin business owners. In a public records request, the Oregon Health Authority disclosed that as of January 27, 2023, applications have been submitted for 6 manufacturer licenses, 3 service center licenses, and 1 laboratory license. These numbers reflect the contemplative approach that many prospective psilocybin business owners are taking in Oregon. As we progress through the year, we anticipate a moderate surge in license applications. Until then, we just have to wait to see how things shake out. As Dave mentions in the article, there is a concern that there may be too many facilitators and not enough service centers, at least at the outset. “I hope it will eventually stabilize into a sustainable, thriving ecosystem,” he says.

 Other Noteworthy News

Psychedelics Bills Filed in Four More States as 2023 Reform Efforts Heat Up
“Another series of psychedelics reform bills have been introduced in states from New Hampshire to Hawaii, building on the movement that’s seen exceptional activity in the 2023 session. Sen. Ron Kouchi (D) [in Hawaii] filed a bill to create a “therapeutic psilocybin working group” that would be tasked with studying the “medicinal and therapeutic effects of psilocybin or psilocybin-based products” for conditions such as anxiety, depression and post-traumatic stress disorder (PTSD). The body would also need to look into the efficacy of therapeutic psilocybin programs that are being implemented in Colorado and Oregon. A bill from Rep. Matthew Santonastaso (R) [in New Hampshire] would simply remove the psychedelic DMT from the list of controlled substances under state statute. A Republican New Hampshire lawmaker also recently filed a bill to legalize the possession and use of psychedelics like psilocybin and LSD by adults 21 and older. Sen. Nathalia Fernandez (D) [in New York] has filed a bill to legalize psilocybin therapy for patients with qualifying conditions. Under the proposal, people could receive psilocybin treatment from a certified facilitator in a clinical setting, or at their home if they’re unable to travel. In Utah, Senate Minority Leader Luz Escamilla (D) has announced plans to soon file legislation to legalize psilocybin for people with serious mental health conditions. In West Virginia, Rep. Kayla Young (D) filed a bill that would simply remove psilocybin, marijuana and THC from the state’s list of controlled substances.”
Colorado Appoints Natural Medicine Advisory Board to Share Psychedelic Program
“On Friday, Governor Jared Polis announced members of the Colorado Natural Medicine Advisory Board. This fifteen-member board sits within the Department of Regulatory Agencies (DORA), where it will advise regulators drafting rules for the state’s psilocybin program. The board consists of two types of appointees. The first group will serve two-year terms, and the second will serve four-year terms. All but one of the appointed members reside in Colorado. At least on the surface, few board members appear to have experience directly related to psychedelics. Several board members have experience related to drug policy or substance use treatment.”
Senator to Present Medical Hallucinogens Legalization Bill
“A senator with the Ecological Green Party of Mexico (PVEM) has committed to presenting a bill to legalize and regulate natural hallucinogenic substances such as psilocybin for the treatment of mental health problems such as depression and anxiety. The PVEM senator told forum attendees — among whom were indigenous leaders, traditional healers and scientists — that in Mexico’s indigenous towns, there is ‘infinite wisdom and knowledge about psilocybin mushrooms and what they can do for people’s mental health.’ There has been a “prohibitionist policy” on natural hallucinogens since the 1960s, and the General Health Law considers such substances as ‘psychotropic with no therapeutic value’ and a ‘problem for public health,’ she added. The senator said that several countries have decriminalized substances such as psilocybin to treat mental health disorders and it’s ‘urgent’ for Mexico to do the same.”
Baylor Launches Program Focused on Bioethics and Health Policy of Psychedelics Research
“Research into the medical use of psychedelics to treat mental health is on the rise, but the impact of this research remains unclear. To address questions around this issue, the Center for Medical Ethics and Health Policy at Baylor College of Medicine is launching a new program to explore Ethical and Legal Implications of Psychedelics In Society (ELIPSIS). As part of the new program, experts will outline policies and ethical guidelines for psychedelic research, examine legal implications of psychedelic use for medical care, measure psychosocial impacts of psychedelic research and help to train the next generation of scholars interested in ethical and policy issues related to psychedelics. A multidisciplinary team of experts in bioethics, social science, medicine, health policy and law will study the ethical legal and social implications of this research.”

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PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.
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FRANCHISE LAW

Franchisors

Franchise law is a heavily regulated area of law.  We help clients expand their businesses through franchising and other distribution methods. We have experience in many industries including, restaurants, health, and beauty, alcohol, and cannabis among others. Our representative services include the following:

Franchisees

We also help potential franchisees interested in buying a franchise. We are able to assist with evaluation of franchise opportunities with respect to:

Alternative Structures

However, not all businesses are suited to franchise. We are also experienced with helping clients structure alternative distribution methods to prevent classification as a franchise.

MERGERS AND ACQUISITIONS

Our M&A attorneys are highly experienced in counseling clients who are considering acquisitions or exit strategies.  We have many years of experience handling deals of various types and sizes, ranging from sales of small closely-held business, private companies, and publicly-traded corporations.  We have represented business owners, private equity firms and investment banks in a wide range of industries. 

We have a deep business bench, and Emerge attorneys have handled transactions of all shapes and sizes.  Whether your deal is valued at $100,000 or $100,000,000, our experienced attorneys will guide you through the deal process.

We understand the intensity, technical skill and judgment needed to get deals done, and we provide our clients with timely, practical and cost-effective legal advice.  We are highly capable in all aspects of M&A, including the following:

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.

Emerge attorneys were instrumental in the drafting and passage of Oregon Measure 91, legalizing marijuana in the State of Oregon, and have represented cannabis businesses well before many law firms were willing to enter the cannabis industry. As a firm that has provided legal services in the cannabis space for many years, we are familiar with the unique and complex issues businesses and individuals face in an emerging and highly regulated industry.

We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS

There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including terminally ill patients suffering with anxiety and depression. Until recently, psychedelic substances have been accessible only in the illicit market and are illegal under federal and state to manufacture, distribute, or possess. These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application. As such, no one invested in this area or required legal services, outside of the criminal context.

Today, researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the Controlled Substances Act. Companies are now actively raising money to develop intellectual property and seize market opportunities associated with psychedelic drugs.

In addition, advocates at the state and local levels are not waiting for the rescheduling of these substances and are active in undertaking efforts to decriminalize these substances and/or make them affirmatively legal under state and/or municipal law. Decriminalization already has occurred in cities including Denver, Oakland, Santa Cruz, and Ann Arbor. Oregon is poised to be the first state to make psilocybin therapy affirmatively legal. Emerge Law Group is working with a wide array of clients pushing forward in this emerging area.

See our Psychedelics Practice Group page for more information.

TAXATION

CORPORATE AND PARTNERSHIP TAX

Businesses of all kinds benefit from a customized but systematic approach to structuring legal relationships. Emerge Law Group helps businesses and business owners with a variety of tax planning matters.

Representative client services include:

ESTATE PLANNING

Estate planning encompasses everything from a will and power of attorney to combined estate and business succession planning. In almost all cases, the purpose of the plan is to help the client protect those they care about most in the event they can no longer be there for them.

Emerge Law Group has experience with a wide range of tools used in estate planning, including wills, trusts, and family business entity planning.

TAX CONTROVERSIES

Emerge Law Group can assist with the resolution of difficult tax controversies. Our areas of emphasis and experience include:

REAL ESTATE TRANSACTIONS

Emerge Law Group assists clients with a wide range of real estate transactional matters.  We regularly help clients with:

LAND USE

Emerge Law Group also assists clients with all aspects of local government land use and development processes, ranging from preliminary property analyses and building permit issues to complex land use reviews and hearings. Our attorneys are experienced in obtaining land use entitlements and development permits for a wide range of uses.

We regularly help clients with:

Above all, we understand the value of working with cities and counties to enhance communities while developing the land to its potential. We strive to create solutions to land use issues that serve to better our clients and the communities in which they live and work.

LITIGATION AND ALTERNATIVE DISPUTE RESOLUTION

The attorneys in Emerge Law Group’s Litigation and Alternative Dispute Resolution practice group litigate commercial, intellectual property, and public interest matters in state and federal courts, as well as private mediation and arbitration proceedings.  Our lawyers have represented national and regional financial institutions, major media, entertainment and technology companies, and other Fortune 500 companies in a broad array of high-stakes disputes.  Our team of litigators has handled leading cases that have shaped the law in cutting-edge business, technology, free speech, and public interest impact lawsuits in trial and the courts of appeal.

We have particular expertise in handling civil litigation and regulatory enforcement matters in the cannabis and psychedelic industries.  While many firms claim expertise in the these industries, few have our depth of experience successfully litigating contract, trademark, partnership, shareholder, land use, and real estate disputes in court and arbitration.  Even fewer firms have our level of experience handling writ of mandate proceedings against the government regulators.

Our litigators practice in California, Oregon, and Washington, but have appeared in state and federal courts nationwide.  Our knowledge of our clients’ businesses, goals and concerns, and our experience litigating at the highest levels, give us unique insight into possible outcomes and pitfalls as we continuously confront issues of new impression.

No matter what the industry, we pride ourselves in achieving our clients’ objectives through efficient and creative solutions primarily designed to avoid disputes in the first place—which is always the best litigation strategy.  Many times, our clients obtain excellent outcomes before or at the earliest stages of litigation because our adversaries quickly recognize the challenges they will face in litigating against us.  When litigation is unavoidable, however, we work hard to provide our clients with both cost-efficient and “big firm” quality representation.

 

INTELLECTUAL PROPERTY

Your intellectual property (or “IP”) strategy can harness your most valuable information and intangible assets including your name, your brand, your designs, your content, your services, and your products — what makes your business stand apart in a competitive world.  We can help you evaluate and build your IP portfolio, then secure it, monetize it, and protect it.

IP encompasses multiple areas of law and different types of information or material.

Our Intellectual Property practice focuses on:

TRADEMARK

Trademarks include names, signs, logos, designs, phrases, slogans, expressions, and sometimes even colors, sounds, or smells that identify or distinguish one business compared to others.  Trademark protection is fundamental in securing your “brand.”

COPYRIGHT

Copyright covers original works of creative authorship fixed in a tangible medium of expression.  This includes literary, dramatic, musical, and artistic works, such as poetry, novels, designs, movies, songs, computer software, and architecture. Copyright does not protect facts, ideas, systems, or methods of operation, although it may protect the way these things are expressed.  Depending upon the type of work, “moral rights” (such as the right of attribution) may be implicated as well.

TRADE SECRET

Trade secret laws can vary somewhat between states, but generally trade secrets cover information, including drawings, cost data, customer lists, formulas, recipes, patterns, compilations, programs, devices, methods, techniques or processes that derive economic value from not being generally known and are the subject of efforts that are “reasonable under the circumstances” to maintain secrecy.

PRIVACY

Depending upon where you live or operate, there is a special patchwork of laws and regulations that protect and regulate personal information.  If you are handling or giving out personal or potentially sensitive information, you may be implicating privacy laws.

PUBLICITY

Publicity rights address the commercial use of an individual’s face, name, image, or likeness.  These rights vary state-to-state.  Marilyn Monroe, for example, lived in multiple states which created complex questions about her publicity rights.

Our Intellectual Property services include:

FINANCIAL INSTITUTIONS

In states where new cannabis banking opportunities exist, Emerge Law Group has the proven expertise in creating canna-banking programs to efficiently capitalize on those opportunities. Our Banking Practice Group specializes in working with banks and credit unions to develop regulatory compliant programs and operational best practices. We also train banking staff to become experts in canna-banking so they can effective understand and manage the risk affiliated with canna-banking.

We regularly help clients with:

EMPLOYMENT LAW

At Emerge Law Group, we recognize that employees are the heart and soul of any successful business.  Our Employment Law Practice Group works with employers to help them effectively manage their workforce, navigate the complex web of federal, state and local employment laws and, if necessary, defend against claims before administrative agencies and in court.

We regularly help clients with:

CORPORATE FINANCE AND SECURITIES

Our corporate finance and securities lawyers are experienced attorneys who have practiced at large law firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We work with clients to help achieve their financing goals while safely navigating the highly technical securities law landscape. 

In addition to representing issuers, we also routinely represent institutional and individual investors, including in connection with fund formation and investments.

Our expertise includes:

We have a deep understanding of the financing options available to businesses, including simple unsecured loans, asset-backed financing, convertible debt, common and preferred equity, crowdfunding and various other structures.  We work closely with our clients to understand their business and financing needs, ensure they are prepared to approach investors and choose the right partners, structure and negotiate terms, navigate the due diligence process and successfully close the deal.

COMPLIANCE AND LICENSING

ALCOHOL AND BEVERAGE INDUSTRY

Emerge attorneys have represented businesses in the alcohol and beverage industry, including wineries, breweries, distilleries, restaurants, bars, movie theaters, golf courses, and gas stations.  We can help you vet new locations, acquire existing locations, and apply for the appropriate liquor license.  We also provide training to comply with applicable rules and regulations, prepare operating procedures, submit renewals, and keep clients protected in the event of any potential violations or administrative hearings.

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.  We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS INDUSTRY

Emerge Law Group is a leader in the psychedelics industry.  There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including veterans struggling with PTSD and terminally ill patients suffering with anxiety and depression.  Until recently, psychedelic substances have been accessible only in the underground; they are illegal under state and federal law to manufacture, distribute, or possess.  These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application.  As such, businesses have not invested in this area or required legal services, outside of the criminal context.

Today, psychedelics are proceeding toward legalization on multiple paths.  Researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the federal Controlled Substances Act, opening legal access to them.  Private and public companies are now actively raising money to develop intellectual property and capitalize on the market opportunities associated with psychedelic drugs.  Opportunities to be early actors in this new arena are tremendous.

See our Psychedelics Practice Group page for more information.

BUSINESS AND CORPORATE

Our business transactions team is made up of highly experienced transactional attorneys who have practiced at large law and accounting firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We understand complex legal matters and provide high quality legal services in a cost-effective manner.  Our clients value our experience, knowledge and judgment.

ENTITY FORMATION

Our team routinely advises clients regarding:

CORPORATE GOVERNANCE

Emerge attorneys also advise on-going concerns with: