The FDA announced it will host its first public hearing on cannabis and cannabis-derived compounds (including hemp-derived CBD) on May 31, 2019 in Silver Spring, Maryland. The notice was published yesterday for public inspection in the Federal Register, and officially published today in the Federal Register.
Here are the key takeaways:
- The public may attend the hearing in person on May 31, 2019 in Silver Spring, Maryland, or via streaming webcast. Registration information is provided in the notice.
- Requests to make oral presentations and comments at the public hearing are due by May 10, 2019. An agenda will be available 5 days prior to the hearing.
- The FDA will transcribe the meeting and will make it accessible when it is available after the hearing. The public will not be allowed to ask questions or make comments during the hearing (other than pre-approved presentations).
- Electronic or written comments will be accepted until July 2, 2019. Electronic submissions will be posted to the FDA’s rulemaking website and will not be confidential.
The stated goal of this first public hearing is “to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform [FDA’s] regulatory oversight of the products.”
The FDA provided a list of questions and issues for consideration at the public hearing and in submitted comments. The main categories of issues for which the FDA is seeking comment include health and safety risks, manufacturing and product quality, and marketing/labeling/sales issues. Some of the questions FDA articulated include:
- Health and Safety Risks: Based on what is known about the safety of products containing cannabis and cannabis-derived compounds, are there particular safety concerns that FDA should consider regarding its regulatory oversight and monitoring of these products?
- Manufacturing and Product Quality: Are there particular standards or processes needed to ensure manufacturing quality and consistency of products containing cannabis or cannabis-derived compounds, including standards applied to evaluate product quality?
- Marketing/Labeling/Sales: How should consumers be informed about the risks associated with such products (e.g., directions for use, warnings)? What specific risks should consumers be informed about? Are there any subpopulations for which additional warnings or restrictions are appropriate?
For a full list of questions and topics the FDA identified, please click here and here.
This advisory is a publication of Davis Wright Tremaine LLP. Our purpose in publishing this advisory is to inform our clients and friends of recent legal developments. It is not intended, nor should it be used, as a substitute for specific legal advice as legal counsel may only be given in response to inquiries regarding particular situations. Manufacturing, cultivation, distribution and possession of cannabis remains illegal under federal law and under certain state laws, and is strictly regulated in those states which have legalized medical or recreational cannabis.