The Food and Drug Administration (FDA) has issued an announcement seeking public comment on the “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use” of cannabis and several other substances now under international review.
This announcement comes in response to the upcoming meeting of the World Health Organization’s Expert Committee on Drug Dependence (ECDD) in Geneva, Switzerland in November. The ECDD will be evaluating whether to recommend that certain international restrictions be placed on the plant.
Under current U.S. federal law as well as global drug policy agreements, cannabis is classified in the most restrictive category of Schedule I. Consequently, nations who are signatories of such drug control treaties are expected to treat cannabis as an illegal substance, not that this has stopped countries such as Canada and Uruguay from legalizing cannabis nationwide.
Earlier this year, ECDD determined that cannabidiol (CBD), a component of cannabis shown to have medical benefits without intoxicating properties like other cannabinoids such as THC, should not be scheduled under international drug control conventions.
“CBD has been found to be generally well tolerated with a good safety profile,” the UN body found in its critical review. “There is no evidence that CBD as a substance is liable to similar abuse and similar ill-effects as substances…such as cannabis or THC, respectively.” The Committee went on to recommend that preparations considered to be pure CBD should not be scheduled.
This determination confirms a statement by the FDA that CBD should be completely removed from federal control. Specifically, the agency found that CBD has a “negligible potential for abuse” and has a “currently accepted medical use in treatment.”
Despite this, because of the international drug treaty obligations, the FDA conceded that the substance should be placed under the least-restrictive category of Schedule V.
Having said that, in its analysis to DEA the FDA noted that “if treaty obligations do not require control of CBD, or if the international controls on CBD change in the future, this recommendation will need to be promptly revisited.”
The FDA’s statement that was released in May preceded the ECDD determination that CBD should not be globally scheduled, and was part of the federal government’s approval and rescheduling last month of CBD-based drug Epidiolex, which is used for severe epilepsy disorders.
The ECDD has also agreed to undergo an in-depth critical review of the marijuana plant and its resins and extracts, including CBD and THC. That new review is what triggered the FDA’s request for public comment.
For now, the FDA will be accepting comments on cannabis as well as the other substances currently under review until October 31, 2018. Interested parties can submit written comments here.