supplement, providing a pathway
forward for hemp-derived products.”
The legislation would be something of a
coup for farmers who embraced hemp
after the Farm Bill legalized the plant in
December 2018.
It would likely receive the backing
of Majority Leader Mitch McConnell
(R-Kentucky), who has encouraged the
state’s struggling tobacco farmers to
move into hemp production.
Wall Street initially anticipated that CBD
foods and drinks would contribute to
more than $15 billion in annual sales.
However, many of the big names were
scared off when the FDA raised concerns
about the safety of CBD products last
year.
Ben & Jerry’s recently said that it would
move forward with plans to create CBD
ice cream ‘only if the FDA approved the
compound.’
The FDA has been cracking down heavily
on CBD supplements over the past year,
using its discretion to target companies
making outlandish medical claims.
In November, it sent warning letters to 15
companies it said had used their websites
and social media platforms to market
CBD products in ways that violated food,
drug and cosmetics safety laws.
This included medical claims such as
CBD: “could help manage . . . Alzheimer’s
disease and autism. ... contains powerful
fatty acids that fi ght yeast and bacterial
growth.”
The FDA also indicated that it ‘cannot
conclude that CBD is generally
recognised as safe (GRAS) among
qualifi ed experts for its use in human or
animal food.’
FDA principal deputy commissioner,
Amy Abernethy, MD, PhD, said:
“We remain concerned that some people
wrongly think that the myriad of CBD
products on the market, many of which
are illegal, have been evaluated by the
FDA and determined to be safe, or that
trying CBD ‘can’t hurt.’
“Aside from one prescription drug
approved to treat two paediatric epilepsy
disorders, these products have not been
approved by the FDA and we want to be
clear that a number of questions remain
regarding CBD’s safety.”
The regulator issued a Consumer
Update the same day that the warning
letters were sent, stating that CBD has
the potential to harm and cause side
effects that users may not notice. It also
“This bill
will provide
a pathway
forward for
hemp-derived
products”
said that there’s still a lot that we don’t
know about CBD.
The FDA is continuing to draw up
regulatory pathways for the many
types of CBD products now available
on the market.
In June 2018, Epidiolex became the
fi rst FDA-approved drug derived from
cannabis.
The drug is used to treat seizures
associated with two rare and severe
forms of epilepsy, Lennox-Gastaut
syndrome and Dravet syndrome.
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