On May 21, 2024, the US Department of Justice (DOJ) published the highly anticipated notice of proposed rulemaking (NPRM) to reschedule marijuana (cannabis) from a Schedule I controlled substance to Schedule III, taking the first step to easing federal restrictions on cannabis and potentially opening up the door for further cannabis research and development. This regulatory change could have far-reaching implications for the cannabis, pharmaceutical and banking industries if promulgated in a final rule. Stakeholders interested in submitting comments to the DOJ must do so by July 22, 2024.
DOJ Proposes to Reschedule Marijuana (Cannabis) to Schedule III
By James R. Ravitz, Alva C. Mather, Paul S. Gadiock, Deepika Raj, Marissa Hill Daley and Karis Jackson on June 3, 2024
Tags: cannabis, Controlled Substances Act, CSA, DEA, DOJ, Drug Enforcement Agency, FDA, Financial Crimes Enforcement Network, FinCEN, Food and Drug Administration, HHS, marijuana, marijuana-related businesses, MRBs, SAFER Banking Act, Schedule I drug, Schedule III drug, Section 280E of the Internal Revenue Code, Secure and Fair Enforcement Regulation Banking Act, US Department of Health and Humans Services, US Department of Justice
James R. RavitzJames (Jamie) Ravitz is the co-head of the Firm’s Life Sciences industry practice and head of McDermott’s Food and Drug Administration (FDA) practice. He works alongside clients across the entire spectrum of life sciences and healthcare law, including regulatory counsel, compliance, and investigations and government enforcement. He is particularly focused on Food and Drug Administration (FDA) regulatory counseling. Jamie works in partnership with companies and investors across the complete ecosystem of FDA-regulated products—drugs, devices, health technologies, biologics, food, cosmetics and cannabis— to help them achieve their business goals.Read James R. Ravitz's full bio.
Alva C. MatherAlva Mather is the global head of McDermott’s Regulatory Practice Group and a member of the Firm’s Management Committee, and heads the Alcohol Regulatory & Distribution Practice. As a nationally recognized go-to lawyer for alcohol beverage regulatory, commercial and M&A matters, clients say that Alva “comes to the situation with clear leadership and strong knowledge of the food and beverage industry.” She combines her extensive knowledge of the commercial and legal landscape as well as deep understanding of the beverage industry to help clients mitigate risk, respond to challenges, and capture and pursue new business opportunities. Read Alva Mather's full bio.
Paul S. GadiockPaul Gadiock leverages his firsthand experience at the Food and Drug Administration (FDA) to provide life sciences, healthcare and other FDA-regulated companies with practical, strategic counsel at every phase of the product life cycle. Paul supports medical device, digital therapeutic, and biopharma companies, software as a medical device (SaMD) and clinical decision support (CDS) developers, and their investors on their FDA regulatory and due diligence needs, delivering premarket and postmarket regulatory guidance to maximize business outcomes. Read Paul S. Gadiock's full bio.
Deepika RajDeepika Raj advises a broad range of healthcare industry clients on regulatory, compliance and transactional matters. She offers multifaceted advice on state and federal fraud and abuse statutes, licensure rules, cannabis laws and due diligence matters. Read Deepika Raj's full bio.
Marissa Hill DaleyMarissa Hill Daley focuses her practice on healthcare and US Food & Drug Administration (FDA) matters, including advising clients on regulatory compliance, government and internal investigations, and FDA marketing requirements. Marissa also defends clients against whistleblower qui tam suits that involve the False Claims Act and the Anti-Kickback Statute.Read Marissa Hill Daley's full bio.
Karis JacksonKaris Jackson advises healthcare clients on diverse transactional and regulatory issues related to managed care, healthcare policy, US Centers for Medicare & Medicaid Services due process, and Food & Drug Administration and Federal Trade Commission guidance. Her clients include private equity and practice management companies, public and private companies, and healthcare organizations. Read Karis Jackson's full bio.
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