MJBizMag April 2022 - 14

HEMP NOTEBOOK Kristen Nichols
Is the FDA ... Right?
Why U.S. drug regulators don't deserve so much criticism
from the cannabis industry
A
re you sitting down?
Because I have nice things
to say about Enemy No. 1 in
the hemp industry: the U.S. Food
and Drug Administration.
I know, I know! I write this while
ducking metaphorical shoes being
hurled at my head from anyone in
the CBD industry.
As everyone in the hemp
industry knows, the FDA says
that the cannabinoid has great
medicinal value. But the FDA
also says that CBD can't be sold
without a prescription because GW
Pharmaceuticals, now part of Jazz
Pharmaceuticals, has sole clearance
to market the cannabinoid they
researched for 20 years before
getting approval to sell it.
Here's where many in the
cannabis industry roll their eyes:
How can any one company be
awarded an entire market for a
molecule that exists in nature and
has been used therapeutically for
thousands of years?
I understand the frustration. It
makes sense that hemp operators
by the thousands ignore the
" exclusionary rule " that gives
pharmaceutical companies the
ability to profit without any
competition. The rule is downright
un-American.
But as we focus this month on
safety and quality in a cannabis
industry that has grown so big you
can buy cannabinoid treatments at
countless convenience stores and
bodegas, it's worth considering
14 April 2022 | MJBizMagazine
the value of pharmaceutical-grade
cannabis products. Do they have a
place in the industry?
MEDDLING FOR GOOD
Let's back up and consider why the
" exclusionary rule " even exists: In
1994, Congress needed a way to
regulate dietary supplements and
keep quack cure-alls off store
shelves.
At the same time, Congress
needed to preserve a profit motive
for companies to spend decades
(and hundreds of millions of dollars)
researching new drugs for rare
medical conditions. Otherwise,
there would be no incentive for
pharmaceutical firms to develop
anything but blockbuster drugs for
wealthy people.
So, when the FDA gave a
pharmaceutical company the sole
right to market CBD medicine more
than two decades ago, it had good
reason. At the time, there weren't a
lot of companies lining up to drop
nine figures researching a drug
to treat rare types of epilepsy in
patients too young to hold jobs.
NOT JUST GW
We all know GW Pharmaceuticals
wasn't working alone. Basement
and backyard breeders also toiled
for years to unlock the healing
power of the cannabis plant,
work that too often won them
nothing but felony convictions
and jail time.
But that's not the FDA's fault.
Rather than bash the FDA for
not giving CBD operators the green
light to sell products over the
counter, let's acknowledge that
the agency has largely resisted a
national CBD crackdown. (I duck
again to avoid the arrows of those
who have gotten FDA warning
letters-but let's be honest, it could
be much, much worse.)
I also believe the industry
owes a begrudging nod to GW
Pharmaceuticals for jumping
through hoops for more than two
decades to prove that cannabis
contains powerful medicine, then
ignoring over-the-counter CBD
competitors (despite having every
legal right to want them shut
down).
There are sick kids out there
whose parents would never give
them a drug that didn't have
FDA approval. Those kids now
have access to cannabis medicine
because of the pharmaceutical
industry and the annoying
" exclusionary rule. "
Everyone reading this knows that
cannabinoid epilepsy treatments
are just the tip of the iceberg. Let's
not disincentivize pharmaceutical
cannabis research in a scramble to
profit off the plant.
Kristen Nichols
covers hemp for
MJBizMagazine. She can be
reached at kristen.nichols@
hempindustrydaily.com.
MJBizMag April 2022

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