On October 31, 2018, Brownson • Norby, PLLC submitted to FDA a comment in response to FDA’s request for input from stakeholders, the cannabis industry, and other interested persons concerning the “abuse liability and diversion of” substances including the cannabis plant and resin, extracts and tinctures of cannabis, and THC. Oct. 10, 2018 Request for Comments.
FDA’s request for comments was with a view toward “preparing a response from the United States to the World Health Organization (WHO)” in advance of the upcoming meeting this month (November 2018) to address international scheduling of such substances.
Earlier this year, in April, FDA requested comments specifically concerning cannabidiol (“CBD”) in advance of the summer WHO meeting ot discuss international scheduling of CBD — you can see our analysis and comment thereon here: April 23, 2018 Brownson Norby Comment to FDA. Shortly thereafter, in May FDA submitted to DEA a letter with recommendations for scheduling Epidiolex, the recently FDA approved CBD-based drug. FDA Letter to DEA. Importantly, in this letter, FDA suggests that CBD itself is not appropriate for scheduling based on its lack of potential for abuse, as well as its medicinal and therapeutic applications.
We conclude, based on consideration of these data and with respect to the eight factors, that CBD and its salts, with a limit of [redacted] THC, do not have a significant potential for abuse and could be removed from control under the CSA.
Why is this important? Well, it signals that FDA appears to be coming around on CBD and it may also indicate that FDA took the industry comments on CBD into consideration.
You may also be wondering, why does it matter what happens on the international level — we should be concerned with the federal view of CBD and cannabis. The answer to that question is: we are concerned about what happens at the federal level, which is why we must be concerned with what happens at the international level. This is because the United States is a signatory to treaties concerning international drug control, and as such it is bound to adhering to international drug schedules. In light of this, DEA’s acting administrator has “asserted that the United States would not be able to keep its obligations under the 1961 Single Convention on Narcotic drugs if CBD were decontrolled under the CSA.” As such, change must start at the very top (the international level) before it can be effected at the federal level.
We will continue to monitor this and other matters touching on CBD. To read the comment we submitted, please click here: Oct. 31, 2018 Brownson Norby Comment to FDA