Contrary to some accounts of the meaning of an announcement in the Federal Register, CBD remains a Schedule 1 drug. The FDA has rescheduled only Epidiolex, a brand of medicine made by GW Pharmaceuticals and approved only for treatment of two types of severe seizure disorder. All other types of CBD product are still illegal under federal law.
Near the beginning of the announcement, these words appear: “this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V.”
This seems to reschedule anything that has no more than 0.1 percent tetrahydrocannabinol, but it does not. It may at this point be helpful to review what rescheduling is. The Controlled Substances Act (CSA) is the federal law under which marijuana is classified, or scheduled. Marijuana is listed under Schedule 1 of the act as a drug with “a high potential for abuse” and that “has no currently accepted medical use in treatment in the United States.” The schedule goes up to five. Drugs in that schedule have “a low potential for abuse” and has a currently accepted medical use in treatment in the United States.
What the order in the Federal Register does is move only Epidiolex to Schedule Five by bureaucratic fiat. Since Epidiolex now has a medically approved use, it does not belong on Schedule 1 anymore. After a short history of the drug’s approval by the FDA, the order goes on to say:
Epidiolex is an oral solution that contains cannabidiol (CBD) extracted from the cannabis plant. This is the first FDA-approved drug made from the cannabis plant. Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA….DEA must therefore take the appropriate scheduling action to remove the drug from schedule I.
Narrow as this order is, it is highly significant, as it shows the way that other CBD drugs may be approved, which in turn could lead to a blanket approval of CBD medications. If a particular type of CBD drug is shown through medical trials to be effective, as Epidiolex was, it may obtain FDA approval, and that approval may result in the drug’s being rescheduled from Schedule 1 to Schedule 5.
The FDA approved Epidiolex after controlled clinical trials. In a prepared statement, FDA Commissioner Scott Gottlieb, M.D., cited the approval of Epidiolex as a means of approval for additional controlled testing of medical marijuana products. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients,” he said, adding:
We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
While CBD remains Schedule 1 drug, the government’s moving of Epidiolex to Schedule 5 is an indication that more may be to come.
What do you think? Will big drug companies sponsor more CBD studies? Will the FDA approve CBD generally? Leave a comment below.