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Psychedelics & Emerging Therapies

The growing body of research into the therapeutic use of psilocybin, ketamine, MDMA, and other psychedelics and emerging therapies is inspiring policymakers, medical experts, and the public to reexamine drug policy at every level of government.

As a firm dedicated to representing emerging industries for over a decade, Vicente LLP understands the complexities of transitioning a controlled substance from a prohibition model to a regulated system. From unique company formations and contracts to obtaining licensure and regulatory compliance, our attorneys and specialists guide clients through the complicated issues that businesses and entrepreneurs encounter in an emerging and highly regulated industry. We also help advocacy groups and state, local, and federal governments develop sensible policy solutions that advance the public interest and ensure decriminalization and responsible regulation of natural medicines. We’ve even worked on groundbreaking litigation against the DEA involving the therapeutic use of psilocybin for terminally ill patients through Right to Try laws.

Whether you are a healthcare practitioner, researcher, producer, manufacturer, investor, patient, community healer, entrepreneur, or government agency, or you are interested or currently manufacturing and researching psychedelics under federal DEA licensure and developing drugs, Vicente is here to help you navigate the growing patchwork of state laws and evolving federal laws regulating psychedelics and emerging therapies—including, but not limited to the Controlled Substances Act, Federal Food, Drug, and Cosmetic Act, and relevant federal and state criminal and drug control laws.

Colorado’s Natural Medicine Health Act

Passed in 2022, The Natural Medicine Health Act (NMHA) decriminalized adult possession of natural medicines (including psilocybin, psilocin, mescaline not derived from peyote, ibogaine and DMT), and initiated the process of creating regulated healing centers in Colorado. Vicente LLP founding partner Joshua Kappel served as the lead drafter and a leading member of the campaign for the NMHA. Our team is actively involved in the development and implementation of the NMHA and other psychedelics laws and policies in the U.S. and abroad.

Healthcare providers, patients, facilitators, government agencies, and others turn to Vicente LLP for strategic guidance, monitoring, and compliance with these new laws. And, through a strategic alliance with Kleinfeld, Kaplan & Becker LLP (KKB), a Washington, D.C.-based firm concentrated on products subject to the jurisdiction of the U.S. Food and Drug Administration (FDA), we help clients develop product development strategies, prepare stances, prepare prosecuting investigational new drug (IND) exemptions and new drug applications (NDA), and comply with current good manufacturing practice (cGMP) and other requirements.

Click the "Services" and “Experience” tabs below to learn more about Vicente LLP’s work in the emerging psychedelics field.

LEADERSHIP

Founding Partner

Services

  • Creation, drafting, and strategic implementation of local, state, and federal psychedelic policy reform measures

  • Monitoring services and strategic guidance regarding state and federal laws governing the personal and commercial use and distribution of psychedelics 

  • Risk assessment for practitioners and other health care professionals providing emerging therapies

  • Risk management advice, including waivers, insurance, professional licensure, and best practices

  • Assisting clients in obtaining DEA and state licensure for the manufacturing and research of psychedelics

  • Guiding clients through the complex federal and state regulations applicable to researching, manufacturing, storing, importing, exporting, and marketing of controlled substances

  • Protecting the religious freedoms and first amendment rights of organizations traditionally involved in entheogen practices

  • Preparing applications for licensure under the Oregon Psilocybin Services Act

  • Preparing applications for licensure under Colorado’s Natural Medicine Health Act

  • Helping professional organizations shape ethical guidelines and set standards for practitioners in emerging therapies

  • Delivering a full suite of compliance services for federally and state-licensed facilities, including facilities growing, researching, and manufacturing psilocybin, LSD and other substances

  • Advising clients regarding the personal use of psychedelics in legal states

  • Providing guidance on FDA, DEA, and FTC compliance

  • Providing full-service corporate representation, including corporate formation

  • Advising on Alternative Corporate Structures, including forming benefit corporations, perpetual purpose trusts, and benefit sharing/honoring

  • Providing counsel on financings:
    • Private placements and other securities law matters
    • Negotiating debt financings such as working capital lines of credit, term loans, and equipment lease financings
    • Angel and venture capital financings
    • Equipment leasing
  • Assisting with commercial contracts, including various agreements and leases

  • Legal guidance for investing in psychedelics businesses
  • Providing strategic guidance for research and intellectual property development

  • Advisement for real estate leasing and licensing issues

  • Advising on issues regarding international trade and supply chain
  • Leading impact litigation cases, including actions against the DEA relating to the scheduling of therapeutic medicine and Right to Try laws 

  • Advocating for federal and state legislation regarding therapeutic access to psychedelics and scheduling reform

Via our alliance with Kleinfeld, Kaplan & Becker, we can assist with:

  • Navigating federal and state regulations applicable to researching, manufacturing, storing, importing, exporting, and marketing of controlled substances

  • Complying with the FDA requirements for developing, researching, manufacturing, obtaining regulatory approvals and clearances, and marketing novel and emerging therapeutic products

  • Managing issues presented by developing professional licensure and scope-of-practice requirements applicable to researchers and healthcare providers working with novel and emerging therapeutic products

Experience

  • Shaped federal and state psychedelics laws, including providing legal and policy guidance to key federal and state legislators and regulators.

  • Co-authored Colorado Proposition 122—the Natural Medicine Health Act of 2022—the historic state-wide measure that created equitable access to natural psychedelic medicines through a regulated supervised-use model and by decriminalizing personal and communal use.  

  • Assisted Decriminalize Denver with drafting and strategy for the successful 2019 Denver Psilocybin Initiative. The historic local ballot measure designated possession of psilocybin mushrooms by persons age 21 and older the city’s lowest law-enforcement priority, and it prohibited the city from spending resources to impose criminal penalties for such activities. 

  • Advised Decriminalize Nature on the Oakland Community Healing Initiative, including policy and legal considerations applicable to drafting a regulatory system that allows for legal access to entheogens. 

  • Provided compliance services to state and federally licensed facilities growing, researching, and manufacturing psilocybin, cannabis, LSD, and other substances.

  • Provided compliance, regulatory, and strategic counsel for DEA-licensed facilities.

  • Advised the Heroic Hearts Project, a national nonprofit that connects military veterans struggling with mental trauma to ayahuasca therapy retreats.

  • Advised multiple clients engaging in legal psychedelics-based therapy and related services, including drafting liability waivers and advising on corporate structure and procedure.

  • Advised a technology company on legal issues related to psychedelic therapies.

  • Advised an entrepreneur regarding the legality of psilocybin production and research.

  • Advised multiple clients regarding biosynthetic cannabinoid production, including legal analyses with regard to the Controlled Substance Act, the Federal Analogue Act, and similar laws at the state level.

  • Advised a member of the Native American Church regarding unfair treatment by local law enforcement in connection with legal activities with entheogens.

People

Senior Associate Attorney

Senior Associate Attorney

Founding Partner

Director of Economics & Research

Director of Regulatory Compliance

News

Colorado Natural Medicine Advisory Bulletin #7: December 2023

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Jan 18, 2024

Colorado Natural Medicine Advisory Bulletins provide updates on the implementation of Colorado's legal psychedelics program, the Natural Medicine Health Act. Bulletin #7 focuses on updates from the recent subcommittee meetings.

Colorado Natural Medicine Advisory Bulletin #6: November 2023

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Dec 13, 2023

Colorado Natural Medicine Advisory Bulletins provide updates on the implementation of Colorado's legal psychedelics program, the Natural Medicine Health Act. Bulletin #6 focuses on updates from the recent subcommittee meetings and the full meeting of the Natural Medicine Advisory Board.

A Potential Breakthrough for Psychedelic Treatments: Ninth Circuit Court Ruling on Psilocybin Rescheduling

By Jason Adelstone
Dec 7, 2023

On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic mushrooms” from Schedule I to Schedule II. Read this Insights post for more information about the Ninth Circuit Court’s order to reschedule psilocybin.

Colorado Natural Medicine Advisory Bulletin #5: October 2023

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Nov 14, 2023

Colorado Natural Medicine Advisory Bulletins provide updates on the implementation of Colorado's legal psychedelics program, the Natural Medicine Health Act. Bulletin #5 focuses on updates from the October subcommittee meetings and the full meeting of the Natural Medicine Advisory Board.

Colorado Psychedelics Implementation Update: DOR Natural Medicine Division Listening Sessions - Part 1

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Oct 24, 2023

As part of the pre-rulemaking process, the Colorado Department of Revenue's Natural Medicine Division began holding public “Listening Sessions” with the goal of gathering information from the public at large. The October sessions consisted of five, one-hour, online meetings focused on specific topics announced in advance. Read this article for a summary of the first five sessions.

Colorado Natural Medicine Advisory Bulletin #4: September 2023

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Oct 17, 2023

Colorado Natural Medicine Advisory Bulletins provide updates on the implementation of Colorado's legal psychedelics program, the Natural Medicine Health Act. Bulletin #4 focuses on updates from the September subcommittee meetings and the full meeting of the Natural Medicine Advisory Board.

Colorado Natural Medicine Advisory Bulletin #3: August 2023

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Sep 7, 2023

Colorado Natural Medicine Advisory Bulletins provide updates on the implementation of Colorado's legal psychedelics program, the Natural Medicine Health Act. Bulletin #3 focuses on updates from the August subcommittee meetings and the full meeting of the Natural Medicine Advisory Board. In addition, the Department of Revenue will hold NMHA listening sessions throughout September.

Colorado Natural Medicine Advisory Bulletin #2: July 2023

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Aug 14, 2023

Colorado Natural Medicine Advisory Bulletins provide updates on the implementation of Colorado's legal psychedelics program, the Natural Medicine Health Act. Bulletin #2 focuses on updates from the July subcommittee meetings and full meeting of the Natural Medicine Advisory Board.

Colorado Natural Medicine Advisory Bulletin #1: Background

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Aug 14, 2023

Colorado Natural Medicine Advisory Bulletins provide updates on the implementation of Colorado's legal psychedelics program, the Natural Medicine Health Act. Bulletin #1 focuses on the Natural Medicine Advisory Board: What is the board, how does the board work, what subcommittees exist, what have they done so far, and what's next?

City of West Hollywood Community Educational Forum on Psilocybin Features Psychedelics Attorney Joshua Kappel

Jul 12, 2023

Learn about and support psychedelic policy by attending a community educational forum on psilocybin, featuring Vicente LLP founding partner Joshua Kappel, at the West Hollywood City Council Chambers on July 25, 2023. The educational forum will explore the full spectrum of psilocybin-related topics, including a discussion of past and current legislation aimed at decriminalizing psilocybin mushrooms and other hallucinogenic substances.

Join Vicente LLP at Psychedelic Science 2023 in Denver

Jun 7, 2023

The largest psychedelic gathering in history is coming to Denver June 19-23 and Vicente LLP is ecstatic to sponsor the conference and welcome the global psychedelic community to our hometown. Let’s connect at the conference and the many networking events that week!

Legal Guide to Decriminalized Natural Medicine in Colorado

May 29, 2023

Colorado is the first state to decriminalize natural psychedelics for personal and communal use. This guide contains information on personal use, civil protections, and Colorado's regulated natural medicine access program. Natural psychedelics remain illegal under federal law. Please be conscientious and know the laws.

The Ultimate Guide to SB23-290, Colorado’s Natural Medicine Regulation and Legalization Bill

By Joshua Kappel, Juliana Todeschi, George Winfrey
May 24, 2023

Another key step in bringing natural psychedelic medicine to Colorado was completed this week. Governor Polis signed SB23-290, the Natural Medicine Health Act’s implementation bill. This bill is the most comprehensive piece of legislation ever passed by a state government related to a state-authorized natural psychedelic medicine program. It builds upon the values of the NMHA with a renewed focus on indigenous voices, safety, and regulatory efficiency. The measure goes into effect on July 1, 2023. Read our full analysis of the bill.

Buying a Ketamine Clinic: Why, How, and Risks to Understand

May 11, 2023

With ketamine being the only approved psychedelic drug for medical use, ketamine clinics offer a unique opportunity for investors and entrepreneurs looking to enter the expanding market of innovative mental health therapies. In this article, we will explore the reasons behind the growing demand for ketamine clinics and the unique regulatory considerations involved in transactions involving these businesses.

What You Need to Know About SB23-290, Colorado’s Natural Medicine Health Act Implementation Bill

By Genevieve Meehan and Sara Simons
May 3, 2023

Since its introduction on April 18, SB23-290, the implementation bill for the Natural Medicine Health Act (NMHA), made its way through the Colorado Legislature and now awaits the governor's signature. Although the bill started off with a couple of policy positions that were antithetical to the voter-initiated act, after a series of amendments and a lot of work by Colorado activists and lawyers, it seems clear SB23-290 builds off the intent of the NMHA to create a natural psychedelic ecosystem in Colorado based in equity and safety. Read this Vicente Insights post for key aspects of the bill.

Colorado Psychedelics Update: State House of Representatives Passes Natural Medicine Health Act Implementation Bill SB23-290 with Amendments

By Joshua Kappel
May 1, 2023

Since its introduction on April 18, SB23-290, the implementation bill for the Natural Medicine Health Act (NMHA), made its way through the Colorado House and has now passed with amendments that have generally brought this bill even closer to the original intent of Prop 122! Read this Vicente Insights post for the latest updates and next steps for the bill.    

Colorado Psychedelics Update: Natural Medicine Health Act Implementation Bill SB23-290 Engrossed, Reengrossed, and Heading to the House

By Joshua Kappel, Juliana Todeschi
Apr 25, 2023

Since its introduction on April 18, SB23-290, the implementation bill for the Natural Medicine Health Act (NMHA), has gone through the Colorado Senate Finance and Appropriations Committees and several amendments have been made. The reengrossed version of the now 91-page bill heads to the state House with a new sponsor, Representative Judy Amabile. Read this Vicente Insights post for the latest updates and next steps for the bill.    

[Webinar] Equitable Access & Psychedelics

Apr 13, 2023

Making psychedelic-assisted therapy and training opportunities accessible to historically and systematically oppressed populations is essential to creating a more equitable healthcare model. But how can this be achieved? Watch this webinar for a discussion on equity and psychedelics with professionals from Alchemy Community Therapy Center.

Forming Psychedelic Companies: 10 Lessons from the Cannabis Industry

By Charles Alovisetti
Mar 22, 2023

A new industry is emerging in the United States, and entrepreneurs in the psychedelics space must make critical decisions at the onset of new ventures regarding how to set up and structure their new businesses. Luckily, we have access to another industry with a complex legal framework and a patchwork of different state laws: cannabis. And after forming hundreds of cannabis companies with clients over the past decade, Vicente LLP has lessons to be shared.

[Webinar] Psychedelic Opportunities in Oregon and Colorado

Jan 12, 2023

As states like Oregon and Colorado develop regulated pathways for people to get involved in the regulated psychedelics industry, possibilities—and questions—are increasing: What are the opportunities now, what’s next, and where? Get answers by watching this recorded session.

Oregon Psilocybin Services Releases New Proposed Rules and Public Comment Period

By Yolanda Clarke, Jamie Greenwood
Nov 16, 2022

In another exciting step towards implementing psilocybin services, the Oregon Psilocybin Services Section issued updated proposed rules under the Oregon Psilocybin Services Act this month, making significant changes to the previous iteration. Make your voices heard! The public comment period is open through November 21, 2022.

[Webinar] Cannabis & Psychedelics On the Ballot

Nov 1, 2022

The November 2022 ballot has those interested in cannabis and psychedelic policy reform on their toes. From supporting adult-use cannabis initiatives in Arkansas, Missouri, North Dakota, South Dakota, and Maryland, to potential psychedelic reform in Colorado, there is plenty of excitement!

Colorado Prop 122: A Transformative Measure Grounded in Equity and Healing

By Joshua Kappel and Tucker Wentz
Oct 11, 2022

Vicente Sederberg LLP is proud to stand with Natural Medicine Colorado and support Proposition 122. This measure not only provides safe access to natural psychedelic medicines, but does so in a way that is grounded in equity and conscious capitalism while also protecting legacy communities and existing medicine keepers.

The Natural Medicine Health Act of 2022: A Measure to Access Psychedelic Medicine in Colorado

By Colleen Mitchell, Yolanda Clarke
Oct 10, 2022

Prop 122 would create a regulated system for adults aged 21 and older to access natural psychedelic medicine, such as psilocybin, in a supervised setting to treat various mental health conditions. It would also allow for the cultivation, possession, personal use, and gifting of psychedelic medicine for adults aged 21 and older. Read this for an overview of the proposition’s key components.

Psychedelics As Medicine: Right To Try Case Versus DEA

By Shane Pennington
Aug 9, 2021

In what could be a groundbreaking case for psychedelic medicine, VS counsel Shane Pennington is part of a team working on an exciting and very important Ninth Circuit challenge to the DEA's refusal to accommodate state and federal right to try laws.

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