CONFIDENTIAL -- TO UNPA MEMBERS ONLY
Dear Colleagues --
The past 10 days have been exceptionally active on the HE/C front. There has been big news nearly every day. Here is a brief summary, just to keep you informed, and a more in-depth analysis and strategic proposal will follow early next week.
1) Synthetic cannabinoids de-scheduled by DEA.
2) Congressional staff briefing on cannabis. Yesterday on Capitol Hill a congressional staff briefing was held on the future of cannabis as a drug. This briefing was sponsored by GW, in conjunction with the National Consumers League and other patient interest entities. Later today, Peter Reinecke forwarded handouts from this briefing (attached). Of key interest is the announcement of a January 15 national CBD summit. No details yet. We are investigating and will report back. Also, there are two new GW-funded interest groups: Consumers for Safe CBD and The Collaborative for CBD Science and Safety. Details are found in the attachment. UNPA COMMENT: Today's briefing and the formation of these two groups are again in furtherance of efforts to influence congressional members and staff with regard to CBD-related legislation and to influence regulators, health professionals and the public with regard to the benefits but also risks and hazards of unsupervised use of CBD.
3) Class action lawsuits. You are, no doubt, aware that at least six class action lawsuits were filed in recent days. We attach Josh Long's excellent article detailing this, along with a note from ClassAction.org, which further describes the reasons behind these class action cases. Prospective defendants include: Garden of Life, Charlotte's Web, Barlean's, and CV Sciences. This, we believe, is the beginning of a much more litigious period. We will discuss this further on an upcoming conference call.
4) FDA warning letters. On November 25, FDA announced and issued 15 warning letters (see attachment). This was widely reported in the press. UNPA's Larisa Pavlisk has prepared a brief analysis of these warning letters (also attached), which is informative with respect to the type of claims made, the class of product (DS, food, pet, other) as well as who from FDA sent each warning letter. Several things are very clear. Explicit drug claims are a lightning rod. Food products (gummies in particular) are a high risk item, and FDA is beginning to develop an enforcement theme that consuming CBD presents risks to the elderly, to children, those on multiple drugs, etc. Once again, these themes resonate and are consistent with the general messages being conveyed via the pharmaceutical sector.
5) Journal of Dietary Supplements article. Finally, UNPA has been invited to write a paper to be included in a special issue on cannabidiol in the Journal of Dietary Supplements. Igor Koturbash, our MOU partner at University of Arkansas Medical Sciences, is a special issue editor for this journal. We will call upon our UNPA members interested to co-author UNPA's paper, which will identify a proposed regulatory path for CBD and other cannabinoids, together with other regulatory and policy issues relevant to a lawful status for this class of products. The deadline for submission is March 15, and we will send a separate note asking for expressions of interest to participate in this joint effort.
In addition to the news noted above, there are many other active issues that require a growing level of UNPA staff time as well as Peter and Trish's attention on Capitol Hill.
We are now seeing the end of the "skirmish" phase of the battle over the future of CBD and are entering the active battle to build and influence key constituencies, take and hold territory, and set the template for legislative, regulatory, litigation and the public access to hemp extract, CBD and other cannabinoids.
On a final note, it's also clear that the hemp/CBD and DSHEA 2.0 issues will become a joined issue. This means that all UNPA members and all industry members should consider themselves affected by the outcome of the CBD debate, given the likelihood that DSHEA 2.0 issues will be heavily influenced by the issues and events around hemp extracts and CBD.
Please look for a further update mid-next week as well as a special conference call on December 16 from 11:00-12:30 MT, where we will discuss these and many other issues in more detail. Please consider this a must-attend call and our year-end wrap up of CBD news and UNPA's action plan going forward.