What You Need to Know (And What
We’re Working to Find Out) About
Products Containing Cannabis or
Cannabis-derived Compounds, Including
CBD
The FDA is working to answer questions about the science, safety, and quality of
products containing cannabis and cannabis-derived compounds, particularly CBD.
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Cannabis is a plant of the Cannabaceae family and contains more than eighty
biologically active chemical compounds. The most commonly known compounds
are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the
component that produces the “high” associated with marijuana use. Much interest
has been seen around CBD and its potential related to health benefits.
Marijuana is different from CBD. CBD is a single compound in the cannabis
plant, and marijuana is a type of cannabis plant or plant material that contains
many naturally occurring compounds, including CBD and THC.
The FDA has approved only one CBD product, a prescription drug product to
treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome
(DS), or tuberous sclerosis complex (TSC) in people one year of age and older.
It is currently illegal to market CBD by adding it to a food or labeling it as a
dietary supplement.
The FDA has seen only limited data about CBD safety and these data point to real
risks that need to be considered before taking CBD for any reason.
Some CBD products are being marketed with unproven medical claims and are of
unknown quality.
The FDA will continue to update the public as it learns more about CBD.
Potential harm, side effects and unknowns
1. CBD has the potential to harm you, and harm can happen even before you
become aware of it.
o CBD can cause liver injury.
o CBD can affect how other drugs you are taking work, potentially causing
serious side effects.
o Use of CBD with alcohol or other drugs that slow brain activity, such as
those used to treat anxiety, panic, stress, or sleep disorders, increases the
risk of sedation and drowsiness, which can lead to injuries.
o Male reproductive toxicity, or damage to fertility in males or male
offspring of women who have been exposed, has been reported in studies
of animals exposed to CBD.
2. CBD can cause side effects that you might notice. These side effects should
improve when CBD is stopped or when the amount used is reduced.
o Changes in alertness, most commonly experienced as somnolence
(drowsiness or sleepiness).
o Gastrointestinal distress, most commonly experienced as diarrhea and/or
decreased appetite.
o Changes in mood, most commonly experienced as irritability and
agitation.
3. There are many important aspects about CBD that we just don’t know, such as:
o What happens if you take CBD daily for sustained periods of time?
o What level of intake triggers the known risks associated with CBD?
o How do different methods of consumption affect intake (e.g., oral
consumption, topical , smoking or vaping)?
o What is the effect of CBD on the developing brain (such as on children
who take CBD)?
o What are the effects of CBD on the developing fetus or breastfed
newborn?
o How does CBD interact with herbs and other plant materials?
o Does CBD cause male reproductive toxicity in humans, as has been
reported in studies of animals?
Unanswered questions about the science, safety, and
quality
Unproven medical claims, unsafe manufacturing
practices
Evaluation of the regulatory frameworks
For More Information:
FDA Regulation of Cannabis and Cannabis-Derived Products, Including
Cannabidiol (CBD)
What You Should Know About Using Cannabis, Including CBD, When Pregnant
or Breastfeeding
