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.