MJBiz - November/December 2023 - 54

But even that hurdle now seems like
a formality.
The DEA has never contradicted
health regulators' recommendations on
matters of science and health-and
might lack the authority to do
so-according to an analysis by the
Congressional Research Service
think tank.
That means the DEA is likely to sign
off on the HHS' recommendation
and issue a proposed rule change,
possibly as early as the end of the year,
predicted Howard Sklamberg, a former
top enforcement offi cial at the Food
and Drug Administration who is now
a partner at Washington DC-based law
fi rm Arnold & Porter.
" I don't think that will take terribly
long, " said Sklamberg, who also
correctly predicted that the HHS
recommendation would come more
quickly than many anticipated.
" They're wanting to get this done, "
he added. " They'll want to have the
fi nal rule done certainly by 2024-and
probably not too late in 2024, given the
political cycle. "
That might mean Biden-chief
sponsor and lead agitator for the
notorious 1994 crime bill that fi lled the
nation's prisons with nonviolent drug
offenders-could run for reelection
with " doing more than any other
president to legalize marijuana " on his
resume, which could be a key factor in
cannabis-friendly swing states such as
Florida, Ohio and Pennsylvania.
" Biden was not a friend of
cannabis, " said Aaron Miles, chief
investment offi cer of Chicago-based
marijuana multistate operator Verano
Holdings Corp.
" At one point recently, he was
calling this a 'gateway drug.' For this
administration to embrace this as
medicine is just massive. Massive. "
WHAT'S NEXT
While drugs have been rescheduled
and even descheduled in the past-the
most relevant example being Epidiolex,
Still, there's a generally agreedThe
FDA does not
have the bandwidth
or the resources or
the wherewithal or the
expertise to regulate
this product. They
can't even regulate
CBD. So, what are
they going to do?
Stop inspecting meat
so they can start
cracking down
on cannabis?
-Andrew Kline, Perkins Coie
the hemp-derived, CBD-rich epilepsy
treatment that the DEA classifi ed as a
Schedule 5 drug in 2018 before removing
it from the Controlled Substances
Act (CSA) entirely in 2020-experts
agree there is little precedent for rescheduling
marijuana that would give a
clear picture of what's to follow.
" It's totally fair to say it's
unprecedented, " said Jonathan
Caulkins, a drug-policy researcher and
professor at Carnegie Mellon University
in Pittsburgh.
" This is a botanical, No. 1, " said Kline
of Perkins Coie. " And, No. 2, there has
never been a nationwide marketplace
for a drug that hasn't been approved by
the FDA like this. "
54 November-December 2023 | MJBizMagazine
upon process that the rescheduling
recommendation will follow from here,
policy experts said.
After the DEA weighs how
rescheduling might affect matters
of law and policy-including U.S.
obligations under international drugcontrol
treaties-the agency triggers the
federal rulemaking process laid out in
the Administrative Procedures Act.
The DEA publishes a proposed rule,
then opens a window for public comment-possibly
30 to 60 days. Those
comments will be considered and, in
some cases, answered, either directly
or by a blanket statement addressing
common concerns.
The rule might be issued as soon
as the end of the year, meaning
rescheduling could take effect next
spring.
What the DEA cannot do is contradict
the rescheduling recommendation.
" The DEA has to accept the medical
and scientifi c evaluation, " Kline said.
" That is statutory. "
Observers agree there will almost
certainly be lawsuits, brought by
both legalization foes seeking to
keep marijuana strictly illegal and
by legalization advocates seeking to
deschedule the drug entirely.
Either or both scenarios could lead
to a judge imposing an injunction and
halting the rescheduling process before
the legal complaint is resolved.
Photo by adobe.stock.com/Tada Images
http://adobe.stock.com/Tada

MJBiz - November/December 2023

Table of Contents for the Digital Edition of MJBiz - November/December 2023

MJBiz - November/December 2023 - CT1
MJBiz - November/December 2023 - CT2
MJBiz - November/December 2023 - Cover1
MJBiz - November/December 2023 - Cover2
MJBiz - November/December 2023 - 3
MJBiz - November/December 2023 - 4
MJBiz - November/December 2023 - 5
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