MJBiz - July 2023 - 44
Manufacturing
Milestones
Regulatory changes can force marijuana
manufacturers and retailers to stop
producing high-dose products and
remove them from shelves. Courtesy Photo
Weighing the Costs of GMP
Third-party certification can be laborious and costly,
but it's one way to keep your products on the shelf
By Tim Shaw
W
hen states change their
regulations concerning
high-dose edibles, medical
cannabis patients aren't the only ones
left in the lurch.
Brands that have been forced to take
their high-dose edibles off the market
because of regulatory shifts can find
themselves scrambling, too. Not only
do such companies lose revenue, they
also must navigate the disappointment
of brand-loyal customers.
That's what my company ran into
in 2021, when Maryland capped its
potency limits at 10 milligrams per
44 July 2023 | MJBizMagazine
dose and 100 milligrams per package.
Luckily, there was one way to get our
high-dose products back on the shelf:
current Good Manufacturing Practice
(GMP) certification established by the
U.S. Food and Drug Administration.
The FDA updated GMP guidelines
most recently in 2015 to help
companies achieve the highest possible
standards for consumer safety. Thirdparty
GMP certification is available
to any manufacturer that is willing
to go through a stringent (and often
expensive) approval process.
Because the bar set by GMP is so
high, some states have baked this
certification into their cannabis
regulations-particularly for CBD
products marketed as dietary
supplements and for cannabis edibles.
Florida, for example, made GMP
certification a requirement for licensed
cannabis producers to participate
in the state's medical-only market.
Maryland-which has a medical market
and is launching adult-use cannabis in
July-is less explicit, instead tying GMP
certification to potency caps.
Maryland regulations stipulate
that marijuana edibles contain no
MJBiz - July 2023
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MJBiz - July 2023 - Cover1
MJBiz - July 2023 - Cover2
MJBiz - July 2023 - 3
MJBiz - July 2023 - 4
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