CBD Southwest There’s a lot of excitement about the healing potential of CBD – with good reason.
But it wasn’t until June 25, 2018, that the U.S. Food and Drug Administration (FDA) recognized cannabidiol as a medicine by approving Epidiolex, an almost pure pharmaceutical CBD formulation, as a treatment for two severe pediatric seizure disorders, Lennox-Gastaut syndrome and Dravet syndrome.
This was the first time since the peak of the reefer madness era 80 years ago – when “marijuana” became a crime instead of a cure — that the federal government had given an official thumbs-up for a cannabis-derived product.
In response to the FDA’s historic decision, the Drug Enforcement Administration (DEA) announced in September 2018 that it had removed Epidiolex from Schedule I classification, a category reserved for dangerous drugs with no medical value. Henceforth, Epidiolex would be considered a Schedule V drug, the least dangerous designation under the Controlled Substances Act. The DEA later “descheduled” Epidiolex and removed it from the federal government’s list of controlled substances.
But the DEA kept cannabis and CBD (when derived from a cannabis plant with more than 0.3 % THC) on Schedule I as an illegal narcotic. In the world according to Uncle Sam, pharmaceutical CBD is officially the only good cannabinoid while the rest of the plant remains an ‘evil’ weed.
Given CBD’s reputation as a popular, artisanal remedy, one would think that Epidiolex would command a lot of “off label” attention. After all, physicians often prescribe pharmaceuticals off label to treat conditions that were not the actual focus of clinical trials. But the costly price tag for Epidiolex (more than $30,000 annually) precludes off label prescribing as well as affordable access for tens of millions of Americans without health insurance.