Dear Colleagues --
FDA has announced it will hold a public hearing to receive comments regarding scientific data and information about products containing cannabis or cannabis-derived compounds (see attached Federal Notice). Cutting to the chase, this means CBD.
This hearing will include invited speakers, as yet not announced, as well as a public comment period for anyone wishing to make a brief statement. FDA will also receive written comments through July 2, 2019. Larisa Pavlick and I will be attending the meeting. We have not yet decided whether to request a speaking slot during the public comment period.
We will, of course, provide a detailed summary and color commentary of the hearing, together with additional news and information leading up to and after this important meeting.
You will recall that now departed Commissioner Gottlieb stated in mid-February FDA's intention to seek Congressional direction with respect to a regulatory pathway for cannabis products. And it should be noted that FDA's interests extend to foods, drugs, dietary supplements, medical devices, and veterinary products, given the wildfire-like growth of CBD-containing products in all of these categories. FDA, correctly, is seeking a comprehensive regulatory strategy for cannabis products under FDA jurisdiction. This excludes recreational and medicinal dispensary products.
As federal register notices are tedious to read, we hope you will find the attached mark-up helpful and easier to understand. Here is a quick summary for those that want a quick snapshot:
1) FDA raises a number of specific questions related to health and safety risks as well as manufacturing and quality issues.
2) We believe the core issues that FDA is really concerned about are:
So, it boils down to this. FDA is inviting industries seeking to sell CBD to justify rationale to recognize the lawful status of CBD by regulation or Congressional action rather than food additive petition, GRAS affirmation with notice, or a New Dietary Ingredient Notification. As FDA has noted, the explosive growth of the CBD category is far outpacing the normal regulatory process which, in this case, could take a number of years.
The stakes are rising very quickly with massive investments being made, hundreds, if not thousands of CBD products being launched or in the works, and a growing alarm within the pharmaceutical industry of erosion of drug research incentives and approval processes. Basically, everybody wants an answer to the question, "What is the legal status of CBD?" The only more pressing question is, "How does Game of Thrones end?" I'm afraid we can't help you on either count.