A new drug derived from marijuana led to a landmark change in the US government’s stance on cannabis in late September.
After being greenlit over the summer as the first federally approved marijuana-based medication, an epilepsy drug called Epidiolex triggered the nation’s top drug enforcer to change how it regulates CBD, the compound in marijuana not responsible for a high. It’s the first time in 46 years that the agency has shifted its stance on the marijuana compound.
The move was somewhat unexpected. Barbara Carreno, a representative from Drug Enforcement Administration, initially told Business Insider that she expected the agency to reschedule CBD entirely — not just federally-approved drugs made with CBD.
Carreno added that the move would unleash what she called a “sea change” for CBD manufacturers and the industry as a whole, which up until this point has existed in a legal grey area.
But it appears that sea change may not occur after all. Only drugs already approved by the Food and Drug Administration will now be considered Schedule 5, the agency announced last Thursday.
Still, researchers, advocates, and entrepreneurs told Business Insider they thought the move was good news overall for patients and for the CBD industry as a whole, which has been pegged as a roughly $1 billion business. Here’s why.
The move makes the medication available, but limits research
Laura Lubbers, the chief scientific officer of a nonprofit called Cure that funds epilepsy research, told Business Insider that she was neither disappointed nor “necessarily pleased” with the DEA’s decision, but felt it was good news overall that Epidiolex, which treats two rare forms of epilepsy, could finally get into the hands of patients who need it.
“I’ve had so many people asking me: ‘When is this coming? When is this going to happen?’,” Lubbers said.
Now that the DEA has made its decision, patients can officially get Epidiolex with a doctor’s prescription.
But the research on CBD will continue to be limited, Lubbers added.
That’s because as it stands, CBD remains a Schedule 1 substance — unless it’s inside of a federally-approved medication. That means it’s still difficult for many researchers to access and study, Lubbers said. Conversely, if the agency had decided to put all CBD — whether in a medication or not — in the Schedule 5 category, more people would be able to get their hands on it and research the compound’s potential benefits.
“CBD is already a precious commodity and now it’ll be directed towards patients, which is good, but it’ll be harder for researchers to access and study it” than it would be if the DEA had fully rescheduled CBD, Lubbers said.
“I think the research will move forward but at a slower pace than people would want,” she added.
The DEA’s move could help keep unvetted products off the market
Still, the DEA’s move may also help keep the booming CBD industry — which manufactures products that range from dog treats to coffee— in check.
That’s because the CBD in Epidiolex is manufactured and produced under strict standards, just like any other FDA-approved drug. The CBD in many other products is not.
“The main thing is that CBD as approved by the FDA is pharmaceutical-grade CBD,” Shlomo Shinnar, the president of the American Epilepsy Society and a professor of neurology and epidemiology at the Albert Einstein College of Medicine, told Business Insider in June. “That’s not the same as when people tell you, ‘Oh, I’ve got marijuana and it’s high in CBD,’ or ‘Oh, I’ve got a CBD product.'”
As it stands, the products are poorly regulated, meaning there is wide variation in content, safety, and price.
For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 CBD products purchased from 31 different online retailers. Roughly seven out of 10 items had different levels of CBD than what was written on the label. Of all of the items tested, roughly half had more CBD than was indicated; a quarter had less. And 18 of the samples tested positive for THC, despite it not being listed on the label.
“If the entire compound were to be rescheduled, there would be an even greater emergence of companies trying to ride the CBD wave, and these companies may or may not create a high quality product,” Kelvin Harrylall, the CEO of a company called The CBD Palace (which audits CBD companies and creates a list of vendors it deems safe for customers), told Business Insider.
“I am eager for the day when the schedule changes for the entire industry, but the issue isn’t as simple as just reclassifying CBD,” Harrylall said. “I believe the CBD industry as a whole will benefit from this, and those that continue to make a good product will grow and shine, while those that are not will slowly recede.”