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.
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.
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
Assisting with commercial contracts, including various agreements and leases
Providing strategic guidance for research and intellectual property development
Advisement for real estate leasing and licensing issues
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
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.
Mar 22, 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? Tune in to a Vicente LLP webinar on Thursday, April 13 at 1 p.m. MT for a discussion on equity and psychedelics with professionals from Alchemy Community Therapy Center.
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.
By Shane Pennington
Mar 1, 2023
How TGA's rescheduling of psilocybin and MDMA shines a bright light on DEA delinquency
Feb 23, 2023
Calling all cannabis and psychedelic industry professionals! RSVP to attend our private networking event and fundraiser during SXSW in Austin, co-hosted with Grasslands: A Journalism-Minded Agency.
By Krissy Atterholt
Feb 14, 2023
Michigan leads the Midwest in affording its communities local protection for psychedelic-based activities. This article gives a breakdown of notable moments in Michigan's psychedelic legislative history.
Feb 9, 2023
What is microdosing and what does the path to legalizing responsible psychedelic use look like? Get the low-down from the Third Wave Podcast featuring Josh Kappel, Alli Schaper and Marie Mbouni, M.D.
By Yolanda Clarke and Jaime Greenwood
Feb 3, 2023
Colorado's Natural Medicine Health Act provides a path for responsible access to psychedelic natural medicines. If you're interested in the personal use of natural medicines in Colorado, read this article to find out what is and is not permitted.
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.
Jan 10, 2023
Certain psychedelics were decriminalized in Colorado, now what? Join Chacruna’s Community Forum on January 18 for an in-depth discussion about the Natural Medicine Health Act.
Jan 6, 2023
"Can I start selling mushrooms in Colorado now?" Joshua Kappel answers your questions about Proposition 122 on the Psychedelics Passage podcast. Listen here!
Dec 23, 2022
On January 7, 2023, the VS team will provide legal services at a drug conviction record sealing clinic in Denver, Colorado.
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.
Nov 4, 2022
Josh Kappel recently discussed everything related to Proposition 122: The Natural Medicine Health Act with Higher Practice Podcast. Listen now!
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!
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.
By Marc Ross
Oct 11, 2022
Colorado Prop 122, The Natural Medicine Health Act, requires that licensed entities participating in the Natural Medicine Regulated Access Program must meet specific ESG criteria.
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.
By Sally Kent Peebles
Sep 9, 2022
Oregon Health Authority published the remaining draft rules to implement 'Measure 109' – the Oregon voter initiative passed in November 2020 which directed the OHA to license and regulate psilocybin products and the provision of psilocybin services. Read more about psilocybin licensing rules.
Sep 7, 2022
Don’t miss the Emergence Psychedelic Education Festival on October 1, 2022. The event will feature psychedelic practitioners and advocates, including VS’s Barine Majewska.
Aug 10, 2022
Josh Kappel will be featured in a legalization and regulation panel at the Psychedelic Law Summit hosted by InsidePractice, "Legalization or Regulation: Pathways to Psychedelic Access"
Aug 8, 2022
VS founding partner Joshua Kappel was a featured guest on a panel hosted by Into The Multiverse Podcast to discuss the history and future of psychedelic microdosing.
Jul 22, 2022
Joshua Kappel was interviewed by Psychedelica Lex to discuss his advocacy for the Colorado Natural Medicine Health Act, a measure on the Fall ballot.
Jul 22, 2022
It's official! Coloradans will have the chance to vote on a historic ballot initiative this year to legalize possession of certain psychedelics, establish a therapeutic model for supervised psilocybin treatment and provide a pathway for record sealing for prior convictions.
By Charlie Alovisetti, Genevieve Meehan, Josh Kappel
May 27, 2022
Do commercial opportunities for entrepreneurs exist in psychedelics? We explore the current limited legal pathways and potential opportunities via proposed legislation and ballot initiatives in this article.
Jan 19, 2022
Watch this live session on Thursday, January 27 at 12 p.m. MT to explore the latest in local and national psychedelics policy, with a focus on initiatives in Colorado and Denver.
Dec 13, 2021
Update on psychedelics-related legislation and rulemaking, regulatory changes, and other noteworthy psychedelics news and events.
By Charles Alovisetti, Joshua Kappel, Andrea Golan
Dec 2, 2021
As we wait for federal legalization and/or state-regulated psilocybin markets to emerge, what can a motivated entrepreneur interested in mycelium pursue?
By Shane Pennington
Oct 18, 2021
An introduction to the different registrations available for schedule I substances such as psilocybin and psilocin.
By James Nechleba
Oct 6, 2021
How can mental health practitioners map the new territory of psychedelics use in mental health therapy and stay within Colorado law?
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.
By Barine Majewska
Aug 4, 2021
When we discuss inclusivity in the quickly emerging psychedelic industry, it is important to also acknowledge the inclusivity of different viewpoints about the administration of psychedelic medicine.