(Alexandria, VA) – SAM today applauded the rescheduling of Epidiolex, an FDA-approved medication derived from the marijuana plant that contains 99.9% pure cannabidiol (CBD).
The Drug Enforcement Administration (DEA) published a notice in the Federal Register that moves FDA-approved drugs that contain CBD derived from marijuana and no more than 0.1 percent tetrahydrocannabinols (THC) from schedule I to schedule V.
“The approval of an FDA-approved CBD product is a very encouraging development,” said Kevin Sabet, President of SAM. “SAM has long been advocating for research into legitimate medicines derived from marijuana that can actually be prescribed by physicians. This is how we conduct scientific research and practice modern medicine in America. In contrast, marijuana sold in dispensaries are often contaminated and mislabeled.”
The scheduling system, as established by the Controlled Substances Act, is not an index of harm, but an implementation of international treaty requirements for the acceptable medical use of substances that have a potential for abuse. Because whole-plant marijuana has not been standardized, dosed, and passed FDA clinical trials, the FDA has denied several petitions to reschedule the whole plant, most recently in 2016. A court of appeals recently rejected a challenge to that denial.
The FDA has issued several rounds of warning letters to the producers of dispensary marijuana products, some of which were found to contain no CBD, some with high levels of THC, and some contaminated with mold or pesticides.
“The FDA process protects both patients and doctors by ensuring that the products are made with Good Manufacturing Processes and contain medicine patients actually need. Many doctors are reluctant to recommend dispensary products because they know they are exposing their patients to harmful products and themselves to medical malpractice claims,” Sabet said.