What has the DEA done?
Cannabidiol (CBD) is a highly sought after cannabinoid or biochemical found only in cannabis. It’s thought to possess certain medical properties. While more research is needed, there is plenty of anecdotal evidence that CBD has anticonvulsant properties. It can relieve the symptoms of extreme childhood epileptic conditions, such as Dravet’s syndrome and Lennox-Gastaut syndrome. For normal, healthy adults, CBD is thought to help increase focus, decrease anxiety, and aid sleep. Despite all this, cannabidiol is still illegal federally, which until recently has left the Drug Enforcement Agency (DEA) in a bind.
What the DEA has just done is accept an FDA approved medication called Epidiolex. This is the first drug that contains an actual cannabinoid, CBD, rather than a synthetic equivalent. The drug is manufactured by Brittain’s G.W. Pharmaceuticals. G.W.’s stock skyrocketed after the DEA’s late September announcement. Now, drugs containing CBD and approved by the FDA, have been moved from a schedule I designation, under the Controlled Substances Act, to a schedule V. The FDA originally approved Epidiolex at the end of June.
Schedule I is the harshest classification, meaning a drug has a high potential for abuse and serves no medical purpose. This is the same level as heroin and LSD. Schedule V means a substance has a significant medical benefit with a low potential for abuse. Cough medicine containing codeine is an example of a drug at this level. Drugs containing CBD, according to the DEA, cannot possess over 0.1% of THC–the cannabinoid that induces a euphoric feeling or high. Although perhaps not going as far as many in the cannabis industry would like, the move is still significant.
What About Natural CBD?
According to officials, Epidiolex will soon be available by prescription, just as any other medication. Officials at G.W. estimate it should take about six weeks before the drug is on the market. Some patient’s parents are already lamenting the price tag, which, in a call to investors was estimated at about $32,500 per year. Although creams, lotions, honey, candies, capsules, and other products containing CBD are widely available throughout the US, technically they’re still illegal, federally, even though they have no psychoactive properties and there’s no record of CBD inflicting any harm.
Since state law often accepts products containing CBD, the DEA typically doesn’t pursue vendors selling such items. The FDA’s announcement in June made clear, however, that the agency is not telegraphing widespread approval. In fact, FDA Commissioner Scott Gottlieb voiced concerns over unregulated CBD products, suggesting that “unproven medical claims,” make such products illegitimate.
G.W. Pharmaceuticals CEO Justin Gover told Business Insider their next move is a THC-derived drug, a nasal spray meant to help relieve the spasticity common with multiple sclerosis patients. The question is, does this signal a sea change in the federal government’s outlook on cannabinoids, or, does it merely illustrate a bias towards Big Pharma. One argument against small operators being allowed to put out federally legal CBD products is that the content of such products often has different levels of CBD than reported on the label, as a recent study revealed.
However, this is more of an argument for better regulatory policies and greater oversight. Although small CBD producers are still locked out federally, more research into CBD, THC, and the other 400-plus cannabinoids will likely loosen federal law. As such, we might see greater opportunities for small to medium-size operations in the near future. The question is, is the federal government giving big players like G.W. a head start?
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