On Friday, May 31, 2019, the U.S. Food and Drug Administration (FDA) held a public hearing to discuss scientific data and information about products containing cannabis or cannabis-derived compounds. Acting Commissioner Sharpless made no new announcements about FDA’s current thinking about how it will regulate products containing cannabis or cannabis-derived compounds. However, it was clear from the FDA panel’s questions to the various academic, industry, and other stakeholders that FDA is looking for as much data from as many sources as possible. In particular, FDA’s questions focused on age and youth restrictions, dose and route of administration and how they affect the safety of the products, adverse event reporting, and interactions between cannabis/cannabis-derived products and other drugs. In addition, FDA continued to inquire about whether deregulating cannabis and cannabis-derived products would affect the incentive for research on these products.
Industry stakeholders asked for a prompt, expedited, clear, and transparent regulatory framework for products containing cannabis and cannabis-derived products. Specifically, industry sought clear definitions for terms like “full spectrum,” “broad spectrum,” “isolate,” and “THC-free.” Further, industry requested regulations on labeling, testing, good manufacturing practices, and track and trace for products. Many industry stakeholders asked FDA to look to the dietary supplement and food regulations already in place as a guideline for regulations on cannabis.
A video of the hearing will be posted by the end of the week and a transcript of the hearing will be available to order about thirty days from the hearing.
We urge stake holders to post to the public docket. The docket number is FDA-2019-N-1482. The docket will close on July 2, 2019. Submit either electronic or written comments on this public hearing by July 2, 2019. The docket may be found here: https://www.regulations.gov/docket?D=FDA-2019-N-1482.
We will be following up with a more detailed analysis in article in a couple week, so check back with us.