FDA Submits Input to HHS Cannabinoid Scheduling Review: CBD Scheduling Recommendation

As part of the broader HHS review of cannabis scheduling initiated following President Biden's October 2022 directive, FDA submitted a formal input memorandum to HHS in August 2024 specifically addressing the scheduling status of cannabidiol (CBD). FDA's memorandum recommends that HHS's scheduling review consider reclassifying CBD given its approval as Epidiolex (a Schedule V controlled substance), the clinical evidence base supporting its medical use, and the public health implications of current scheduling. Key elements of FDA's input: - FDA affirms the eight-factor analysis supports potential reclassification of CBD - Epidiolex approval constitutes a "currently accepted medical use" under the CSA factors - The abuse potential of pure CBD is distinguishable from THC-containing cannabis preparations - Reclassification would not affect Epidiolex's regulatory status as an approved drug - FDA notes the scheduling recommendation is separate from its FDCA food/supplement determinations The DEA has not yet acted on the broader cannabis scheduling initiative, and CBD scheduling is not part of the main cannabis scheduling proceeding.