It has been said that 2018 will go down in history as one of the biggest years in the grand scheme of cannabis reform. Not only did Canada legalize the leaf nationwide for recreational use, but also the U.S. Food and Drug Administration (FDA), one of the gatekeepers to “safe and effective” medicine in the United States, admitted that parts of the cannabis plant, something that the U.S. government has considered a gateway to addiction and social downtrodden for the past several decades, has a place in the treatment of patients suffering from severe forms of epilepsy.
The federal agency recently gave Britain’s GW Pharmaceuticals’ cannabis-based drug Epidiolex, which is comprised of pure cannabidiol (CBD), the green light for distribution in pharmacies all across the nation. This is the first time ever that anything derived from the cannabis plant has been considered fit to mingle with the likes of the American healthcare industry. This, of course, is big. But there is one unsung detail that even is bigger. It seems that tucked inside this major development is a minute reform that no one seems to be talking about – the fact that CBD must now be rescheduled by the U.S. Drug Enforcement Administration (DEA).
It was just a few weeks ago that the FDA gave GW Pharmaceuticals permission to start slinging Epidiolex to epilepsy patients here in the states. The solution, which has been shown effective in reducing seizures in children with Lennox-Gastaut syndrome and Dravet syndrome, will soon be available with a prescription through all major pharmacy chains from Walgreens to CVS. This is significant considering that the federal government still considers any derivative of the cannabis plant a Schedule I dangerous drug – a substance that resides in the same dark closet with heroin. This despite the fact that cannabidiol (CBD) is a non-intoxicating part of marijuana. Even when consumed in large doses, it is impossible to get high from it.
But now that the FDA considers Epidiolex a “safe and effective” treatment option for certain forms of epilepsy, CBD must be downgraded to a Schedule II or III on the DEA’s Controlled Substances Act.
Barbara Carreno, a public affairs representative for the DEA, recently told Business Insider that the agency has 90 days to put CBD into a lower classification. The change is already in progress. Unlike with past petitions aimed at getting cannabis downgraded to a less restrictive classification, the DEA’s pending action with respect to the CBD deal is a prerequisite to the launch of Epidiolex.
“We don’t have a choice on that,” she said. “It absolutely has to become Schedule 2 or 3.”
A reschedule of the CBD compound is necessary to uphold the Controlled Substance Act. Because CBD’s current listing as a Schedule I drug suggests that it has “no known medicinal value,” the FDA cannot allow Epidiolex to go to market without making a change. It is the same reason that opioid medications, like OxyContin and Percocet, are listed as Schedule II even though these narcotics are essentially the same drug as heroin – listed Schedule I. It’s Uncle Sam’s sneaky way of skirting its own rules in the interest of profits. Just ask Hustler magazine publisher and cannabis investor Larry Flynt.
Sadly, not much is expected to change from a CBD reschedule. In reality, the cannabis scene probably will not experience any difference at all. At best, the DEA tossing CBD into a Schedule II or III classification will open up some additional research opportunities that have been sandbagged under Schedule I. That’s about the extent of it. But this doesn’t mean it will be easier for the scientific community to explore the medicinal benefits of whole plant marijuana. The FDA recently rejected a petition to include Tetrahydrocannabinol (THC) and other cannabis derivatives on its list of over-the-counter medications that are considered safe and effective. The agency basically said that while no additional federal restrictions would be imposed on the herb, it was not being let out of its cage.
Furthermore, FDA Commissioner Scott Gottlieb is not keen on certain kinds of medical marijuana. He said recently that the agency would likely never hand down approval for a cannabis product as long as it was presented in smokeable form. Not impossible — just not probable.
“Using a lung as a drug delivery vehicle isn’t optimal,” he said. “That’s not to say that we wouldn’t evaluate it if it came in; it just wouldn’t be an optimal way to deliver an active ingredient.”
If marijuana ever finds its way to nationwide legalization in the U.S. in a manner similar to beer, a modified version of the Alcohol and Tobacco Tax and Trade Bureau (TTB), not the FDA, would be responsible for regulating most cannabis products.
But as long as marijuana is considered a Schedule I dangerous drug, any research geared toward the discovery of therapeutic properties will remain almost non-existent. What’s more is a CBD reschedule will do nothing to alleviate the conflict between state and federal law. Sure, it will be easier for doctors nationwide to prescribe medical grade CBD to some of their patients. But since Epidiolex is the only FDA-approved medication of its kind — and it is exclusively for children with epilepsy — patients with conditions ranging from chronic pain to cancer will not be prescribed the drug as an alternative to traditional medications.
In order for a situation like that to open up, members of the cannabis industry would have to pull together some mega-bucks to seek FDA-approval for their respective products. It is a process that costs billions of dollars to bring to fruition. It is unlikely, at this juncture, that even the most successful cannabis company has the resources to take such an ambitious plunge into the American drug game.
But the FDA says it is open to it if they want to give it a try.
“We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market,” Gottlieb said last year in a statement.
Once CBD is rescheduled, cannabis companies will still not have the freedom to make unsubstantiated claims about their cannabis products. Any business telling customers that their CBD oil shrinks tumors or cures cancer is likely to catch some heat. As far as the FDA is concerned, the only benefit CBD provides is making life more palatable to some patients with severe seizure disorders. Nothing more.