Statement from Hoban Law Group on the FDA Approval of Epidiolex
As many in the hemp industry have long expected, earlier this week the FDA approved Epidiolex -- which contains cannabidiol (CBD) isolate derived from marijuana -- as a prescription drug for treatment of epileptic conditions, Dravet or Lennox-Gastaut syndromes.
As we sit here today, this approval has no impact on the law surrounding industrial hemp and the recent positive rulings concerning the legality of industrial hemp and cannabinoids. Namely, in the recent HIA v. DEA suit (in the Ninth Circuit), the Court unequivocally determined that hemp (and its derivatives) produced domestically under the 'Farm Bill' is not a controlled substance. In fact, the Court found that the Farm Bill (as it relates to hemp) "preempts" the Controlled Substances Act; Congress exempted Farm Bill hemp from the Controlled Substances Act (CSA). In addition to DEA's statements and directive referenced below, these are all very positive things for the hemp industry, and makes it clear that Farm Bill hemp and related cannabinoids are not unlawful, or controlled substances...period.
As to Epidiolex's approval, we now expect the DEA to undertake a process to evaluate how to amend its schedules to allow for Epidiolex to be prescribed and dispensed accordingly. To that end, DEA has conceded it does not "seek to control cannabinoids," and that only cannabinoids derived from marijuana (e.g., flowers and resins of a cannabis plant above .3% THC) are controlled under the Controlled Substances Act.
Moreover, on May 22, 2018, the DEA issued a directive to federal agencies (Customs and Border Patrol, in particular), which states that cannabinoids are not controlled substances unless they fall under the definition of marijuana, and that the "mere presence of cannabinoids" in any product or derivative does not render it a controlled substance. Thus, it is our expectation that DEA adheres to its statements and we, as an industry, need to hold DEA to that.
Further, it is important to note that FDA's position concerning CBD also remains unaffected by this approval of Epidiolex -- the FDA established this position based upon the prior submission of an IND application years ago. We will simultaneously be evaluating options to, and stand ready to, overturn FDA's position towards CBD to ensure that hemp-derived supplements and other similar products are protected underneath FDA's regulatory framework.
Yet, the hemp industry's position concerning the rightful place of hemp-derived extracts as appropriate food additives and dietary ingredients also remains unchanged in light of this approval. There remain questions as whether FDA's invocation of certain technical provisions of the FD&C Act are appropriate and accurate, and whether the long history of hemp-derived supplement in fact would preclude FDA's position. Further, the demonstration of attaining GRAS status, as some in the industry have already self-affirmed or are in the process of doing so, is further reasoning that FDA should treat these additives and ingredients appropriately.