Earlier this month, on April 9, 2018, FDA published a notice requesting comments from the public on the scheduling of cannabis-related substances (“Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol”). See here: FDA Request for Comments.
As of today, April 20, 2018–a renowned cannabis holiday–nearly 6,ooo comments have been posted. The deadline to submit comments is Monday, April 23, 2018.
FDA Request for Comments
By way of overview, FDA seeks comments from “interested persons” regarding: the potential for abuse, information about actual abuse, medical uses, and other relevant details regarding cannabis to inform its response to the World Health Organization (“WHO”) regarding “abuse liability and diversion of these drugs.”
WHO will use this information to consider whether to recommend that certain international restirctions be placed on these drugs.
Much like the United States’ Controlled Substances Act, there is a similar scheduling of substances at the international level. In June of this year, a meeting will convene to discuss the scheduling of cannabis and its constituents on the international level. In advance of this meeting, the various “states” (i.e. countries that are a part of the 1961 Convention overseeing international drug laws) have an opportunity to submit responses and comments to WHO for consideration. As such, FDA’s request for input from interested persons is an opportunity for Americans to voice their position on cannabis’ legal status. Many who have already commented have used FDA’s request not only as an opportunity to voice their opinion on how FDA should respond to WHO, but also as an opportunity to campaign for the rescheduling — or descheduling — of cannabis in the United States.
In the Interim, FDA Panel Approves Epidiolex
Yesterday, April 19, 2018, FDA published the conclusions of a panel reviewing the new drug application for Epidiolex — a product containing CBD. In short, the panel approved Epidiolex. (See here for more details). While this is not the final hurdle for the product to become an FDA approved drug, it is a significant accomplishment. This particularly so in light of the conclusions surrounding CBD–a substance that has been at the center of a great deal of controversy over the past few years (see our article on Indiana and CBD):
The Controlled Substances Staff evaluated the abuse potential of cannabidiol in nonclinical studies and in a human abuse potential study, and has concluded that CBD has a negligible abuse potential.
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Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with [Lennox-Gastaut Syndrome and Dravet Syndrome].
These findings are important to the discussion of scheduling substances because the potential for abuse and lack of medical applications are two of the central factors for assigning a substance Schedule I status. (See DEA Schedule Outline.) While many, including WHO, have stated that CBD poses no potential for abuse and possess strong potential for medical and therapeutic applications, we have yet to see this conclusion from the federal government–until now. (See WHO Report on CBD.) As such, this is an important development.
Brownson • Norby to Submit Comment
Our firm will be submitting a comment to FDA focusing on CBD, which we will publish on our website. For any questions about submitting your own comment, or for questions regarding cannabis, please contact Tom Norby.