On August 11, DEA published a press release that was supposed to reveal an important decision whether cannabis was going to be rescheduled from its Schedule 1 label. Lots of cannabis lovers hoped that this decision would finally change the situation with legalizing marijuana, but it seems that they will have to wait a bit longer.
While preparing for the voting on cannabis legalization in California, marijuana activists had high hopes for the Drug Enforcement Administration's (DEA) decision, which was rumored to deschedule cannabis from Schedule 1. However, the decision they published on Thursday was to leave cannabis as a Schedule 1 drug, at least until the FDA sends them enough evidence and studies to change the situation.
The main reason why the DEA denied two petitions to reschedule cannabis is the lack of scientific studies. The petitions were submitted by Bryan A. Krumm, Washington State Governor Jay R. Inslee, and Rhode Island Governor Gina M. Raimondo. DEA replied to these petitions with a four-page letter, explaining their decision in detail.
The decision not to remove cannabis from Schedule I was explained with the following.
Fortunately, the DEA is going to change their policy about studies on cannabis. So far, the only approved cannabis manufacturer is situated in the University of Mississippi. In its announcement, the DEA claims it wants to open more manufacturers to conduct more studies on cannabis that would comply with the FDA rules.
Currently, the DEA has 350 applications of researchers who are looking for registration confirmation to conduct studies on marijuana and its components. As they report, the DEA has approved all application for studies on marijuana. Moreover, the DEA became more loyal to those who want to grow marijuana for researchers to use and allowed more people to register for this purpose.
Apart from that, they also asked the Department of Health and Human Services (HHS) for “a scientific and medical evaluation and scheduling recommendation.” So far, HHS believes that cannabis has high potential for abuse and not enough evidence of medical benefits for human health. Moreover, according to HHS, marijuana lacks safety for use even under medical supervision and, therefore, it should remain in the Schedule I list.
The accompanying document named “Preliminary Note Regarding Treaty Considerations” explains in detail that marijuana will remain on at least Schedule II level due to the U.S. obligations under international drug control treaties.
Therefore, it seems that the DEA will not reschedule cannabis unless the FDA confirms that it can be used as medicine. So it is not only the DEA who decides. In fact, the procedure is more complicated than it might seem. The DEA studies a substance to find out whether it meets the eight criteria in the Controlled Substances Act for controlling. Once the substance passes the test, the DEA sends all the information to the Department of Health and Human Services. DHHS proceeds with a certain amount of scientific studies, and according to their results, they can recommend the DEA either to schedule or to reschedule the substance.
The DEA cannot ignore their recommendation, and if DHHS recommend to schedule or reschedule something, the DEA starts the regulatory process of complying with the recommendations. The DEA can only take actions if other government agencies, such as the FDA, conduct enough studies and collect enough evidence on changing the situation about one or another substance. Right now, the FDA does not have enough information about cannabis, that is why their recommendation is not to move cannabis to any other schedule. Once they have more information, more trials conducted, the changes will become possible.
Despite the decision not to reschedule cannabis yet, the DEA is still considering to do it in the future. It will happen, of course, only if the FDA finds and confirms medicinal qualities of marijuana and, therefore, approves the changes in the scheduling of the substance.
At this moment, the FDA is providing trials for Epidiolex, in which the main component is CBD. If the FDA approves the drug, the chances are big that at least the CBD compound will be rescheduled to the Schedule II level.