FDA Announces Next Steps in Cannabis Regulation
The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for cannabis and cannabidiol (CBD) products. Specifically, this includes a public hearing, an agency working group, question-and-answer updates and the possibility of enforcement actions.
A public hearing on May 31, 2019, aims to obtain “scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Electronic or written comments will be accepted until July 2, 2019. FDA is seeking comments, data and information related to (i) what levels of cannabis cause safety concerns; (ii) how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, cannabis; (iii) how cannabis interacts with other substances; and (iv) standardized definitions for cannabis-related ingredients, supply chain quality control, effective marketing and labeling of risks to the general public or vulnerable populations.
FDA also intends to form a “high-level” internal agency working group to explore pathways for dietary supplements and food products containing CBD to be legally marketed. In addition, the agency has updated its questions-and-answers page regarding FDA regulation of cannabis and cannabis-derived products.
Cannabis products may also become subject to potential enforcement actions. In his most recent Congressional testimony, FDA Commissioner Scott Gottlieb stated that the agency is using “enforcement discretion” and is taking action against perceived “over-the-line” claims against those marketing CBD and “claiming that it can cure cancer or prevent Alzheimer’s disease … because that can mislead a patient into forgoing otherwise effective therapy.” The agency has warned multiple companies—including Advanced Spine and Pain LLC, Nutra Pure and PotNetwork Holdings Inc.—that their claims about the benefits of CBD establish their products as new drugs.
For more information about cannabis-related legal issues, please contact Shook Partners Greg Wu or Katie Gates Calderon.
Reporting provided by Shook Partner Greg Wu and Associate Ruth Anne French-Hodson.
