The good news for the industry is that FDA “recognize[s] the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward."
At the U.S. Food and Drug Administration’s (FDA) public hearing on May 31, 2019 (read more about the hearing), over 100 people presented to a panel of FDA stakeholders and to over 500 attendees. Last week, FDA stated in a post that it recognizes the “significant public interest in these products, for therapeutic purposes and otherwise” but reiterated that “there are many unanswered questions about the science, safety, and quality of many of these products.”
The good news for the industry is that FDA “recognize[s] the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward,” including “being transparent and up-front” as they continue to collect data and information on CBD. FDA is taking an “Agency-wide, integrated, and collaborative approach” to regulating products made from CBD and is exploring potential pathways to market for CBD products. However, FDA still grapples with how to balance the desire for widespread availability of CBD products with the desire to preserve incentives for research and drug development of CBD products.
FDA also stated that it had “several significant takeaways” from the hearing. Specifically, that there is a general “desire for a regulatory pathway to enable lawful marketing of cannabis-derived products (especially CBD) in food and dietary supplements, with appropriate regulatory oversight.” This regulatory oversight includes “clear safety standards and strong enforcement; the need to support research evaluating the therapeutic effects of CBD; the need for consistent terminology related to these products; and, the need for industry standards to address the potentially dangerous manufacturing quality issues with some cannabis-derived products on the market today.”
Some of the outstanding questions FDA is considering include:
- How much CBD is safe to consume in a day? How does it vary depending on what form it’s taken?
- Are there drug interactions that need to be monitored?
- What are the impacts to special populations like children, the elderly, and pregnant or lactating women?
- What are the risks of long-term exposure?
On June 20, 2019, FDA issued a notice that it is extending the period to provide public or confidential comments from July 2, 2019, to July 16, 2019. FDA will review all public and confidential comments as they draft rules to regulate products containing cannabis and cannabis-derived compounds. FDA stated that it believed this two-week extension will allow for adequate time to submit comments without significantly delaying any action on these issues. If you have any information that would be helpful to answering FDA’s questions or that you believe should be considered by FDA, especially data, we encourage you to submit electronic or written comments to the docket.
For More Information
If you have any questions about this Alert, please contact Frederick R. Ball, Carolyn A. Alenci, any of the attorneys in our Life Sciences, Biotech, Medical Devices, Pharmaceuticals and Biologics Group, attorneys in our Cannabis Industry Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.