1
ADVISORY
Substance Abuse and Mental Health
Services Administration
FEBRUARY 2023
CANNABIDIOL (CBD) – POTENTIAL HARMS,
SIDE EFFECTS, AND UNKNOWNS
The use of non-Food and Drug Administration (FDA)-approved cannabidiol, or CBD, has gained
attention in recent years, as CBD is becoming increasingly popular and is being marketed
for various health conditions.
1
A poll of American adults aged 18 years and older found that
14 percent reported using CBD products in 2019, and a similar poll conducted in 2020 found
that as many as 1 in 3 adults reported using CBD products.
2-3
However, non-FDA-approved,
commercial CBD products marketed to the public and available over the counter dier signicantly
in composition from those used in clinical studies,
4
and there is limited evidence to support their
safety.
5
The public should be aware of the misconceptions surrounding CBD products, as well as
the potential harms and risks associated with their use.
Key Messages
● Cannabidiol (CBD) and delta-9-tetrahydrocannabinol (delta-9 THC) are two of many chemical
compounds called cannabinoids that are found in the cannabis plant. CBD, which in its pure
form does not produce any psychoactive eects,
6-7
is typically derived from the hemp plant.
Nevertheless, CBD products, except for the prescription medication Epidiolex,
1, 8
are not
FDA-approved, so despite being marketed extensively, there are no federal standards for their
content, purity, or potency
.9
● The concentration of CBD may be more or less than advertised and, because of a lack of
quality control, the manufacturing process may introduce harmful biological and chemical
contaminants, including the psychoactive THC.
5-6
The lack of safety standards, accuracy
in labeling, and quality control may lead to additional concerns for unintended intoxication,
particularly among children.
● Since federal restrictions on growing cannabis plants that contain low amounts of delta-9
THC were removed in 2018, CBD has become widely available in a range of products and
formulations, including topicals, fabric, food, and beverages.
10
● In 2020, as many as one-third of American adults reported using CBD products.
2
● CBD has been marketed as a treatment for a range of health conditions in recent years;
however, there is a lack of evidence to support many of these claims.
5
● Potential risks and harms associated with CBD use include adverse drug interactions, liver
toxicity, and reproductive and developmental eects.
● Delta-9 THC or delta-9 THC-contaminated products may be sold as CBD. Labeling of these
products may be unclear or misleading, posing a potential threat to a user’s current or prospective
employment, produce inaccurate medical test results, or cause unintended drug interactions.
● More clinical research is needed to determine if CBD products are safe and eective
treatments for the conditions for which they are marketed.
1
2
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
Denitions
Agriculture Improvement Act of 2018:
Dened cannabis plants as hemp or marijuana,
depending on their concentration of delta-9 THC.
Cannabis sativa L.: A plant species used for
producing hemp, marijuana, and other products;
commonly referred to as cannabis.
Cannabinoids: Naturally occurring chemical
compounds found in cannabis plants.
Cannabidiol (CBD): One of two main
cannabinoids found in the cannabis plant; in its
pure form, it has no known psychoactive eect.
Delta-8-tetrahydrocannabinol (Delta-8 THC):
A cannabinoid that is typically manufactured from
CBD and produces psychoactive eects. It is
structurally dierent from delta-9 THC.
Delta-9-tetrahydrocannabinol (Delta-9 THC):
One of two main cannabinoids found in the
cannabis plant; it produces psychoactive eects.
It is potentially more potent than delta-8 THC and
may have more considerable side eects.
FDA-approved product: FDA has determined
that the benets of the product outweigh the
known risks for the intended use.
Hemp: Cannabis plants and products with a
delta-9 THC concentration of no more than 0.3
percent on a dry weight basis.
Marijuana: Cannabis plants and products with
a delta-9 THC concentration greater than 0.3
percent on a dry weight basis.
Psychoactive eects: The eects of a drug or
other substance on the mind (i.e., mind-altering),
such as changes in mood, awareness, thoughts,
feelings, or behavior. Any psychoactive eect is
considered intoxicating (i.e., causes a “high”) for
the purposes of this advisory.
3
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
Overview of Cannabis, CBD, and THC
The cannabis plant produces over 500 chemical compounds;
1
over 100 are cannabinoids—
chemical compounds that produce a range of physical and mental eects.
1, 5, 10
CBD and
delta-9-tetrahydrocannabinol (delta-9 THC) are the two most common cannabinoids,
1, 5, 10
with
the latter having a high potential for misuse because of its psychoactive eects.
12
CBD and
delta-9 THC both bind to receptors in the brain and body but produce dierent eects. Delta-9
THC disrupts many mental and physical functions and produces psychoactive eects; CBD does
not produce psychoactive eects.
6-7
Figure 1 illustrates the current understanding that CBD use is
potentially associated with mostly short-term eects, whereas delta-9 THC use is associated with
short- and long-term eects.
5, 13
Figure 1. Potential Health Eects of Delta-9 THC and CBD
5,13
Delta-8-tetrahydrocannabinol (delta-8 THC) is another increasingly available cannabinoid that
has psychoactive eects.
14-15
Because it is found in cannabis plants in only trace amounts, it is
typically synthesized from CBD by using chemicals. The manufacturing process may introduce
harmful chemical and biological contaminants.
15
The health eects of delta-8 THC are not well
understood,
14
but adverse events have been reported to the FDA and nation’s poison control
centers.
14-15
4
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
CBD versus marijuana: Legal denitions
Cannabis plants and products derived from them are
divided under federal law into two broad categories,
based on their delta-9 THC content: “hemp” and
“marijuana”. Hemp is defined under the Agricultural
Marketing Act of 1946, as amended by the
Agriculture Improvement Act of 2018 (also known
as the Farm Bill), as a cannabis plant or any part of
that
plant with a delta-9 THC concentration of no more
than 0.3 percent on a dry weight basis.
17-19
The Farm Bill considers cannabis plants that cannot
be classied as hemp, because they contain more than 0.3 percent delta-9 THC on a dry weight
basis, to be marijuana.
18-19
This law eectively permitted the legal sale of hemp and hemp-derived
cannabinoid products; however, it does not aect or modify the federal authority to regulate hemp
and hemp-derived products.
10
Nor does it preempt or limit state or tribal laws on hemp production
that are more stringent.
18
Since the Farm Bill was passed in
2018, every state, except for Idaho,
Mississippi, and the District of
Columbia, allows for some form of
hemp cultivation, which increases
access to and availability of hemp
products, including CBD.
16
About CBD Products
Hemp and marijuana plants contain both CBD and THC. CBD is typically derived from hemp
because of its low THC concentration, and THC is typically derived from marijuana plants. There
is currently only one FDA-approved CBD product, Epidiolex, which is a pharmaceutical-grade
CBD oral liquid used for treating rare, severe forms of seizure disorders,
8-9
although its exact
mechanism of action is not fully understood.
10
This product is available only in pharmacies, with a
valid prescription from a healthcare provider.
Although not FDA-approved, CBD is found in a variety of other products, including: lotions, oils,
creams, and other topical products; food and beverage items like chocolate, gummies, other
candy, and tea; cosmetics; fabrics; and products for pets.
20-21
This variety in product types has
contributed to the popularity of CBD, because it can be used in many dierent ways.
22
Availability of CBD Products
The availability of CBD products, other than Epidiolex, varies by state, depending on its
regulations. Over-the-counter CBD products are available throughout the United States, online
or from “brick and mortar” retailers, including drugstores, grocery stores, convenience stores,
and gas stations; however, most CBD sales—greater than 60 percent—are made online.
11
CBD
products purchased over the counter, even from reputable retailers, are not FDA-approved.
23
Many questions about the safety, reliability, and eectiveness of CBD products remain
unanswered.
4, 24-25
CBD products sold at cannabis dispensaries are not FDA-approved and may contain more than
0.3 percent THC, depending on the state’s denition of allowable CBD products.
26
In addition,
although regulations and enforcement vary from state to state,
26
CBD products purchased from
dispensaries may be subject to some form of oversight and standardization.
Marketing and Labeling of CBD Products
The FDA has not approved CBD products to be marketed as food additives or dietary
supplements and has concluded that a new regulatory pathway for CBD is needed; it is prepared
to work with Congress to develop a cross-agency strategy for the regulation of these products.
5,
28
Therefore, over-the-counter CBD products are often advertised as therapies for many health
conditions, even though many of these claims are unproven and the health eects of these
5
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
products are unknown.
5, 8
The FDA has been unable
to evaluate and approve these products for their
marketed use, largely due to limited data to support
their eectiveness.
5
As a result, the FDA sends
warning letters to companies marketing unapproved
products containing CBD with unsubstantiated
claims that they treat certain medical conditions.
21,
24, 29
The FDA also regularly collects data and
evaluates regulatory policies related to cannabis
and cannabis-derived ingredients like CBD.
Nevertheless, the popularity of CBD products
continues to grow. In 2020, CBD products generated
over ve billion dollars in sales,
11
a gure expected
to increase as the market expands.
30
Although Epidiolex is the only FDA-
approved CBD product, CBD is also
marketed for other health conditions.
Presently, there is insucient evidence
to support the use of CBD for many of
the other health conditions for which it
is marketed as treatment.
1, 27
However,
additional research evaluating the
therapeutic ecacy of CBD for various
medical conditions is underway. The
National Center for Complementary
and Integrative Medicine has
summarized available ndings to date.
1
Risks and Harms of CBD Use
Many concerns have been raised about CBD use, particularly with regard to over-the-counter
CBD products, as there are limited data on their safety and eectiveness.
4
These concerns
include adverse events and side eects, questions about their reliability, and unproven health and
wellness claims.
Adverse events and side eects. Potential side eects of CBD include decreases in alertness
(e.g., drowsiness and sedation), changes in mood (e.g., irritability and agitation), decreased
appetite, and gastrointestinal symptoms/distress (e.g., diarrhea).
4-5
CBD may also produce
psychotic eects or cognitive impairment in individuals who also regularly use delta-9 THC
products like marijuana.
4
In addition, CBD use has been associated with adverse events such
as liver injury, interactions with other drugs, injuries following periods of sedation or drowsiness,
and male reproductive harm.
5
Factors inuencing the likelihood of CBD-associated adverse
events and/or side eects include the strength and purity of the product, amount used, mode
of administration, concurrent substance use and misuse (such as legal and illegal drugs and
alcohol), and interactions with prescribed drugs or other medications.
9, 27
Unreliable dosage and purity. CBD products
that are not FDA-approved do not have to
meet any standards for content or potency.
Thus, these products may contain more
or less CBD than stated on the label and,
more concerning, biological and chemical
contaminants due to unsafe manufacturing
practices without adequate process
controls.
6, 9
Research suggests that the
labeled concentrations of CBD products are
unreliable.
20, 31-34
The amount of CBD in over-
the-counter products may range from very
low to levels exceeding FDA-approved dosing for seizure disorders.
27
For example, one study
found that among 84 commercial CBD extracts purchased online from 31 companies, the CBD
concentration was labeled accurately in only 26 (31 percent); almost 43 percent of products were
under-labeled and 26 percent over-labeled.
33
The uncertainty in composition poses signicant
health risks when using these products for medical conditions, particularly in children.
33, 35
A 2020 evidence-based review found little
data to support health benets associated with
over-the-counter CBD products.
4
Most of these
products do not contain pure CBD and may
contain other cannabinoids, including delta-9
THC,
4
and contaminants, such as pesticides.
4
The FDA has ruled that CBD products cannot
be sold legally as dietary supplements and
CBD is not considered a safe additive for food
and beverage products.
27
6
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
The purity of commercial CBD is also highly questionable, with contaminants including the
intoxicant THC.
6, 32, 34
For example, in the previously mentioned study on 84 commercial CBD
extracts, 21.4 percent of the samples contained unlabeled delta-9 THC;
33
another study found
that 3 out of 25 (12 percent) hemp oil products available commercially exceeded the 0.3 percent
concentration limit.
32
Thus users of CBD products that claim to not contain delta-9 THC may still
screen positive for marijuana,
25, 32, 35-36
even at a delta-9 THC concentration as low as 0.02 percent
by weight;
36
it is unlikely that pure CBD will produce a positive urine drug test.
37-38
Individuals
should be aware that delta-8 or delta-9 THC-contaminated products may be sold as pure CBD.
Unclear or misleading labeling may pose work-related, legal, and health risks, given that use
of unsuspected delta-9 THC may threaten an individual’s current or prospective employment,
including athletics, produce inaccurate medical test results, potentially involve law enforcement,
and cause unintended drug interactions.
20, 25, 32, 34-36, 39
Unproven health and wellness claims. Over-the-counter CBD products are marketed for
various health conditions, despite limited evidence of eectiveness or safety.
10
Nevertheless,
the marketing claims may lead individuals to purchase these products without consulting a
healthcare provider
or being aware that they may contain impurities and dierent CBD doses than
used in clinical studies with pharmaceutical-grade CBD.
4-6, 32, 34
Moreover, these individuals may
assume that they are eectively treating their medical condition and therefore not seek medical
care, which can delay receipt of accurate diagnosis and treatment. The FDA recommends that
individuals discuss any medical concerns with a healthcare provider before taking CBD.
5
Unknown health eects. Available evidence suggests that pure (i.e., uncontaminated) CBD,
when used by itself, does not produce any psychoactive eects; however, it does aect the
body, whether ingested or used topically (i.e., placed on skin) and may produce observable side
eects.
27
Uncertainties around CBD use include unknown long-term health eects, proper dosing,
eects on the developing brain, and developmental impacts on fetuses and infants when used by
pregnant and breastfeeding people.
5
The FDA therefore strongly advises against the use of CBD
in any form during pregnancy or while breastfeeding.
40
Other concerns. Like CBD, products containing delta-8 THC are now available for purchase
online and in stores and are being marketed for a range of health conditions;
14
however, these
products have not been evaluated by the FDA and are not considered safe to use.
15
One of the
greatest concerns around delta-8 THC products is that individuals who use them may be misled
to believe that they do not have any psychoactive properties because they are labeled as a hemp
product.
15
There are also concerns around product formulations, purity and dosage, unintentional
product exposure to children and pets, and potential adverse events, such as vomiting,
hallucinations, and loss of consciousness.
15
Tips and Action Steps
Tips and Action Steps for Community Coalitions and Substance Use Prevention
and Treatment Leaders
● Work with local health departments, regulatory agencies, and medical providers to
disseminate the latest evidence on the risks and therapeutic potential of CBD, including that
which is unknown.
● Educate community partners and community members, including adolescents and young
adults, about the short- and possible long-term eects associated with CBD use.
● Implement evidence-based programs to prevent any non-FDA-approved CBD use, particularly
among adolescents and young adults.
7
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
Tips and Action Steps for Healthcare Providers
● Encourage additional clinical research on the eects of CBD.
● Learn about potential interactions of CBD with alcohol and prescription and over-the-counter
medications.
● Educate patients on the potential risks and harms associated with CBD use, including
interactions with prescription drugs, dietary supplements, alcohol, and illicit drugs.
Tips and Action Steps for Parents, Caregivers, and the General Public
● Talk with children about the risks and harms of using products that contain CBD.
● Do not allow children to use over-the-counter CBD products.
● Consult a healthcare provider before using any CBD product.
● Be aware that the risk of CBD products containing delta-9 and/or delta-8 THC is unknown, and
their use may aect employment drug screenings and interactions with law enforcement.
● Do not use CBD concurrently with medications, alcohol, or illicit drugs.
● If you experience adverse events as a result of using CBD products, report them to the FDA
through their MedWatch Safety Information and Adverse Event Reporting Program.
41
Resources
About Cannabis Policy in the United
States
Information about cannabis policy, including the history
of cannabis policy in the United States, issues treated by
cannabis-related law, and federal laws.
FDA Regulation of Cannabis and
Cannabis-Derived Products
FDA resources on CBD policy, including consumer
information and several regulatory resources.
Conversation Goals: Talking with
Teens About Alcohol and Other
Drugs
Conversation goals for parents talking to children about
alcohol and other drugs that can be used to also discuss
CBD.
SAMHSA’s National Helpline
1-800-662-HELP (4357)
A free, condential, 24/7, 365-day-a-year treatment
referral and information service (in English and Spanish)
for individuals and families facing mental and/or
substance use disorders.
Prevent Coalition Prevent Coalition is a community coalition with prevention
resources available for youth and teens, parents, schools,
providers, and rural prevention specialists.
8
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
References
1
National Center for Complementary and Integrative Health (NCCIH). (2019). Cannabis (marijuana)
and cannabinoids: What you need to know. https://www.nccih.nih.gov/health/cannabis-marijuana-and-
cannabinoids-what-you-need-to-know
2
Berger, K. (2021). CBD statistics. https://www.singlecare.com/blog/news/cbd-statistics/
3
Brenan, M. (2019). 14% of Americans say they use CBD products. https://news.gallup.com/poll/263147/
americans-say-cbd-products.aspx
4
Chesney, E., McGuire, P., Freeman, T. P., Strang, J., & Englund, A. (2020). Lack of evidence for
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5
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fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-nd-out-about-
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7
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severe-forms
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12
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01-001
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products containing delta-8 THC and reported cased of adverse events. https://emergency.cdc.gov/
han/2021/han00451.asp
15
Food and Drug Administration (FDA). (2022). 5 Things to know about delta-8 tetrahydrocannabinol
– delta-8 THC. https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-
tetrahydrocannabinol-delta-8-thc
16
National Conference of State Legislatures. (2021). State industrial hemp statutes. https://www.ncsl.org/
research/agriculture-and-rural-development/state-industrial-hemp-statutes.aspx
17
Agricultural Marketing Act of 1946, P. L. No. 115-334 (1946). https://www.agriculture.senate.gov/imo/
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18
Agriculture Improvement Act of 2018 , P. L. No. 115-334 (2018). https://www.congress.gov/115/plaws/
publ334/PLAW-115publ334.pdf
9
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
19
Johnson, R. (2019). Dening hemp: A fact sheet. Congressional Research Service. https://crsreports.
congress.gov/product/pdf/R/R44742
20
Johnson, E., Kilgore, M., & Babalonis, S. (2022). Label accuracy of unregulated cannabidiol (CBD)
products: Measured concentration vs. label claim. Journal of Cannabis Research, 4(1), 28. https://doi.
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21
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health-providing-market
22
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M. (2021). Availability and promotion of cannabidiol (CBD) products in online vape shops. International
Journal of Environmental Research and Public Health, 18(13), 6719. https://doi.org/10.3390/
ijerph18136719
23
Corroon, J., & Kight, R. (2018). Regulatory status of cannabidiol in the United States: A perspective.
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24
Food and Drug Administration (FDA). (2021). FDA warns companies illegally selling over-the-counter
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companies-illegally-selling-over-counter-cbd-products-pain-relief
25
Evans, D. G. (2020). Medical fraud, mislabeling, contamination: All common in CBD products. Missouri
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26
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research/health/state-medical-marijuana-laws.aspx
27
Brown, J. D., & Winterstein, A. G. (2019). Potential adverse drug events and drug-drug interactions
with medical and consumer cannabidiol (CBD) use. Journal of Clinical Medicine, 8(7), 989. https://doi.
org/10.3390/jcm8070989
28
Woodcock, J. (2023). FDA concludes that existing regulatory frameworks for foods and supplements
are not appropriate for cannabidiol, will work with Congress on a new way forward. Food and Drug
Administration (FDA). https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-
regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol
29
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products, including cannabidiol (CBD). https://www.fda.gov/news-events/public-health-focus/fda-
regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
30
Sholler, D. J., Schoene, L., & Spindle, T. R. (2020). Therapeutic ecacy of cannabidiol (CBD): A review
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10
SAMHSA’s mission is to lead public health and service delivery eorts that promote mental health, prevent substance
misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes.
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
ADVISORY
36
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tetrahydrocannabinol after 4 weeks of a full-spectrum, high-cannabidiol treatment in an open-label
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G. E., Flegel, R. R., & Vandrey, R. (2021). Urinary pharmacokinetic prole of cannabidiol (CBD), Δ9-
tetrahydrocannabinol (THC), and their metabolites following oral and vaporized CBD and vaporized
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org/10.1093/jat/bkab059
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Spindle, T. R., Cone, E. J., Kuntz, D., Mitchell, J. M., Bigelow, G. E., Flegel, R., & Vandrey, R. (2020).
Urinary pharmacokinetic prole of cannabinoids following administration of vaporized and oral
cannabidiol and vaporized CBD-dominant cannabis. Journal of Analytical Toxicology, 44(2), 109-125.
https://doi.org/10.1093/jat/bkz080
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event-reporting-program
ADVISORY
SAMHSA Publication No. PEP22
-06-04-004
1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov
Substance Abuse and Mental Health
Services Administration
Acknowledgments: This Advisory was prepared for the Substance Abuse and Mental
Health Services Administration (SAMHSA) under contract number HHSS283201700001/
75S20319F42002 with SAMHSA, U.S. Department of Health and Human Services (HHS).
Donelle Johnson served as contracting ocer representative.
Nondiscrimination Notice: The Substance Abuse and Mental Health Services Administration
(SAMHSA) complies with applicable Federal civil rights laws and does not discriminate on the
basis of race, color, national origin, age, disability, religion, or sex (including pregnancy, sexual
orientation, and gender identity). SAMHSA does not exclude people or treat them dierently
because of race, color, national origin, age, disability, religion, or sex (including pregnancy,
sexual orientation, and gender identity).
Recommended Citation: Substance Abuse and Mental Health Services Administration:
Cannabidiol (CBD) – Potential Harms, Side Eects, and Unknowns. Publication No. PEP22-
06-04-003. Rockville, MD: National Mental Health and Substance Use Policy Laboratory.
Substance Abuse and Mental Health Services Administration, 2023.
Publication No. PEP22-06-04-003
Released 2023