Last week, the Drug Enforcement Agency gave the all-clear for Epidiolex, an epilepsy drug derived from cannabis, to be sold on the market. Though cannabis is still illegal at the national level, Epidiolex is now in the least restrictive category of drug regulation, Schedule V. The move is a good news for pharmaceutical companies that want to develop their own cannabis-based drugs, but it won’t mean much for other cannabis “wellness” products.
Epidiolex, made by GW Pharmaceuticals, treats severe forms of childhood epilepsy and is the first drug derived from natural cannabis that is approved by the US Food and Drug Administration. Epidiolex includes cannabidiol (CBD), a chemical that comes from the cannabis plant that is not psychoactive. (In terms of legality, no one really knows how to classify it yet.)
Though the FDA approved the drug back in April, GW couldn’t sell it because the DEA has deemed cannabis a Schedule I drug along with heroin, LSD, and cocaine, meaning it is considered to have “no currently accepted medical use and a high potential for abuse.” Now, Epidiolex specifically — but not CBD or cannabis in general — is Schedule V. “The DEA is saying, ‘if you’ve satisfied FDA, you’ve satisfied us,’” says Andrew Ittleman, a partner of the law firm Fuerst Ittleman David & Joseph. It’s showing a “fair amount of deference” to the FDA.
In other words: CBD in an FDA-approved product is okay and has a low potential for abuse, and CBD in a product not approved by the FDA is as dangerous as heroin. (Sorry about your CBD lattes.)
Schedule V includes the other anti-seizure drugs, so it makes sense that the DEA made this choice, says Stephanie Yip, an analyst with Informa Pharma Intelligence. For context, other cannabis-based drugs on the market (these are synthetic, whereas Epidiolex is natural) are in Schedules II and III because they contain the psychoactive component THC. Yip adds that, in the past four years, the number of companies doing cannabis research has grown from 16 to 40; these are mostly smaller companies, not including partnerships. The main research interest is pain and then chemotherapy-induced nausea and vomiting.
So expect pharmaceutical companies to take note. But this won’t have much of an effect on the CBD wellness products — including mascara, bath bombs, and weed lube — that are popping up everywhere. “I don’t believe there is a practical application for a cannabis manufacturer,” says Serge Chistov, an investor in Honest Marijuana Company. The government might be softening its grip, but the decision is so limited that “it really doesn’t help us unless we want to go the FDA route.”