T
he CBD regulatory map is more confusing
than ever, as FDA continues to delay its
ruling on the legality of CBD as a food
and dietary supplement additive. On the flip side,
the Hemp Access and Consumer Safety Act was
introduced in Congress in May to make CBD
products exempt from provisions of the Food, Drug
& Cosmetic Act.
This impasse was heightened in June when
FDA released a list of guidance documents that it
intends to issue within the next year. There is no
commitment to publish anything about CBD.
The CBD Controversy
It all began in December 2018, with the passage of
the Farm Bill, permitting the commercial cultivation,
processing, marketing, and sale of industrial hemp
products in the United States. Hemp and derivatives
of cannabis with concentrations of the psychoactive
compound delta-9-tetrahydrocannabinol (THC) were
removed from the definition of marijuana in the
Controlled Substances Act.
Since hemp seed does not contain CBD or THC,
FDA approved hemp seed products—hulled hemp
seed, hemp seed protein powder, and hemp seed
oil—to be used in the U.S. food supply.
Products containing CBD and THC are a more
complicated issue. The FD&C Act prohibits the
addition of an active ingredient in an approved drug
product to a food or dietary supplement. Epidiolex,
a drug used for treatment of seizures in pediatric
disease, was approved in June 2018 and its active
ingredient is CBD. FDA can make an exception for
CBD but the process usually takes three to five years.
In the meantime, farmers aggressively planted
hemp, which could bring more than 10 times
the revenue of traditional crops. Food, beverage,
dietary supplement, and health and beauty aid
manufacturers embraced the supposed "health"
properties of CBD and started adding it to products.
As many have said, the CBD craze is like the Wild
Wild West or the California Gold Rush.
In May 2019, FDA held its first (and last) public
hearing on CBD. More than 500 attended in person
and scores of advocates testified, ranging from state
department of agriculture officials to farmers to
manufacturers to doctors to consumers concerned
about drug addiction.
FDA has expressed many concerns, including
but not limited to:
• CBD has the potential to cause liver
damage and slow brain activity,
which could lead to injuries.
• CBD can cause side effects such as changes in
alertness, gastrointestinal distress, and mood.
FDA questions include:
• What happens if you take CBD daily
for sustained periods of time?
• What level of intake triggers the
known risks associated with CBD?
• How do different methods of consumption
affect intake (e.g., oral consumption,
topical, smoking or vaping)?
CBD Update: The Patchwork
of Regulations Continues
BY RON TANNER
54 SPECIALTY FOOD SPECIALTYFOOD.COM
SPECIALTY FOOD
MAKER
