DEA shift on marijuana CBD could keep industry in check

Shutterstock

• For the first time in 46 years, the Drug Enforcement
  Administration has changed
  its stance on the marijuana compound CBD. 
• Rather than reclassifying
  CBD entirely, the agency changed how it regulates
  federally-approved drugs made with the compound.
• Those drugs — only one of which, called
  Epidiolex, currently exists — are now classified as
  Schedule 5 drugs, meaning they’re the least-strictly regulated.
• Researchers, advocates, and entrepreneurs say the move is
  good news for the
  CBD industry as a whole. Here’s why.
  

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

Shutterstock

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.”