Report to the U.S. House Committe on Appropriations and the U.S. Senate Committee on Appropriations

Cannabidiol (CBD)

Report in Response to Further Consolidated Appropriations Act, 2020

U. S. Food and Drug Administration

The Agency has been taking a variety of concerted actions to advance its continued evaluation of
potential regulatory pathways for FDA-regulated consumer products containing or derived from
cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD). This report
discusses actions FDA has been taking, as well as additional new steps the Agency is taking or
intends to take soon.
While the scientific data in this area continue to develop, we are reporting on FDA’s work to
date to explore possible pathways for various types of CBD products to be lawfully marketed.
FDA is aware that there is a significant interest in the development of therapies and other
consumer products derived from cannabis and its components, including CBD. FDA recognizes
the potential opportunities that CBD may offer and acknowledges the significant interest in these
possibilities. This report does not repeat all the information that we have previously conveyed
on this topic.
FDA continues to be concerned about the potential safety risks of using CBD and about
problems related to a number of currently marketed CBD consumer products under FDA
jurisdiction, like mislabeling or the potential for contamination with delta-9-
tetrahydrocannabinol (THC), pesticides, and heavy metals. In addition, since the May 31, 2019,
public meeting, available data have further demonstrated that CBD is not a risk-free substance.
Consumers should be aware of the potential risks associated with CBD products.
FDA acknowledges the vast proliferation of CBD consumer products, which are sold
increasingly widely since passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill).
Given this proliferation, and limited FDA resources to initiate enforcement action against all
these products, this report outlines an action plan that includes evaluating issuance of a riskbased enforcement policy that would provide greater transparency and clarity regarding FDA’s
enforcement priorities while FDA potentially engages in the process of a rulemaking.
It was difficult to study CBD before the 2018 Farm Bill was passed in December 2018, because
cannabis-derived CBD was a Schedule I controlled substance. Thus, limited systematic data
exist to inform our approach. As more data on CBD become available, we will be able to refine
— and, perhaps in some cases, revise — our thinking and approaches.
This report focuses on the product areas that fall under FDA’s jurisdiction. Key areas include:

  1. Safety
    Currently available clinical data demonstrate that CBD is associated with potential risks,
    including liver injury, drowsiness, and potential for drug interactions.
    1 Animal studies found
    risks including those related to male reproductive toxicity,2 with some risks existing even at the
    lowest levels of exposure studied. FDA is working to further understand the safety profile of
    CBD, especially for sustained and/or cumulative exposure, co-administration with other
    medicines, and vulnerable populations like children, pregnant and lactating women, the elderly,
    and unborn children.
  2. Human and Animal Drugs
    For human and animal drugs, there are clear regulatory pathways available for CBD drug
    development and review of new drug applications (NDAs) and new animal drug applications
    (NADAs). In 2018, FDA approved the NDA for a CBD drug, Epidiolex, for the treatment of
    two rare and life-threatening seizure disorders in children.
    FDA encourages and supports research to explore the therapeutic potential of CBD, as well as
    other compounds in cannabis, and will continue to make available regulatory mechanisms to
    expedite cannabis and CBD drug development as appropriate.
  3. Dietary Supplements
    FDA is actively considering potential pathways for certain CBD products to be marketed as
    dietary supplements. Under current law, CBD products cannot lawfully be marketed as dietary
    supplements, but FDA has the authority to create an exemption through notice-and-comment
    rulemaking (rulemaking) that would allow products containing CBD to be sold legally as dietary
    3 The Agency is actively evaluating what and how much data would be sufficient
    to support a conclusion that CBD can safely be allowed in dietary supplements under certain

1 See, for example, Epidiolex’s prescribing information.
2 See Rosenkrantz H, Fleischman RW, Grant RJ. Toxicity of short-term administration of cannabinoids to rhesus monkeys.
Toxicol. Appl. Pharmacol. 1981 Mar 30;58(1):118-131; Carvalho RK, Souza MR, Santos ML, et al. Chronic cannabidiol
exposure promotes functional impairment in sexual behavior and fertility of male mice. Reprod. Toxicol. 2018 Oct;81:34-40; and
Carvalho RK, Santos ML, Souza MR, et al. Chronic exposure to cannabidiol induces reproductive toxicity in male Swiss mice. J.
Appl. Toxicol. 2018 Sep;38(9):1215-1223.
3 See Section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). For further information, please see FDA
Regulation of Cannabis and Cannabis-Derived Products: Questions & Answers. Available at https://www.fda.gov/newsevents/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd. Current as of
conditions. To further advance and expedite our activities, we are taking steps described below,
which include evaluating issuance of a risk-based enforcement policy that would provide greater
transparency and clarity regarding FDA’s enforcement priorities while FDA potentially engages
in the process of a rulemaking.

  1. Human and Animal Food
    There are established pathways for introducing new substances into the human or animal food
    supply, which apply to hemp-derived substances in the same way as they do to any other
    substances. Under one such pathway, certain hemp seed-derived products (dehulled hemp seeds,
    hemp seed protein, and hemp seed oil), which contain de minimis levels of CBD, currently can
    be lawfully marketed in human food without the need for any further FDA approval, provided
    the products do not make drug claims or claims that are false or misleading, and that they comply
    with all other applicable requirements. Because the same ingredient may present different risks
    to humans and animals, these ingredients would need to be separately evaluated before they
    could be introduced into animal food or feed.
    It is not currently lawful to add CBD to human or animal food,4 and the data currently available
    to FDA raise safety concerns about the use of CBD in food. We encourage interested parties to
    continue to develop and share with FDA information regarding whether there are conditions
    under which CBD could safely be added to food.
  2. Cosmetics
    Cosmetic ingredients do not generally require premarket approval (with the exception that most
    color additives do require premarket approval). Those marketing a cosmetic product are
    responsible for ensuring the safety of the product. FDA is aware of only limited data on CBD
    when used topically. No ingredient — including CBD — can be used in a cosmetic if it causes
    the product to be adulterated or misbranded in any way.
  3. Products Outside FDA’s Jurisdiction
    Although the focus of this report is on products that fall under FDA’s jurisdiction, it is possible
    that some individual products containing CBD fall outside of FDA’s jurisdiction. In such cases,
    FDA would not have authority to exercise regulatory oversight over such products, even to
    address potentially serious matters of public health and safety.
  4. Enforcement
    As FDA works to evaluate potential pathways for the lawful marketing of CBD in products
    regulated by FDA, we are actively obtaining more data about potentially safe levels of CBD and
    evaluating issuance of a risk-based enforcement policy that would provide greater transparency
    and clarity regarding FDA’s enforcement priorities while FDA potentially engages in the process

4 See, e.g., Sections 301(ll) and 409(a) of the FD&C Act. FDA is not currently aware of a basis to conclude that CBD is
generally recognized, among qualified experts, as safe for use in conventional foods. See Section 321(s) of the FD&C Act.
of a rulemaking. Any enforcement policy would need to balance the goals of protecting the
public and providing more clarity to industry and the public regarding FDA’s enforcement
priorities based on the known risks to public health. As we move forward, FDA intends to
continue taking action to address violations we identify that put the public at risk.

What do we know about the effects of CBD use during pregnancy and while breastfeeding?

There is no comprehensive research studying the effects of CBD on the developing fetus, pregnant mother, or breastfed baby. FDA is continuing to collect and study the data on the possible harmful effects of CBD during pregnancy and while breastfeeding. However, based on what we do know, there is significant cause for concern.

High doses of CBD in pregnant test animals have caused problems with the reproductive system of developing male fetuses2 . In addition, based on what we already know about CBD, we expect that some amount of CBD will be transferred to babies through breast milk.

We also know that there is a potential for CBD products to be contaminated with substances that may pose a risk to the fetus or breastfed baby, including THC. We have also heard reports of CBD potentially containing other contaminants (e.g., pesticides, heavy metals, bacteria, and fungus); we are investigating this.

Moreover, CBD has known risks for people in general. Based on clinical studies in humans, risks can include the following:

  • liver toxicity (damage)
  • extreme sleepiness
  • harmful interactions with other drugs

FDA is studying the effects of CBD use from different angles, such as: (1) the use of CBD-containing products, like food, cosmetics, or supplements, over a person’s entire life; and (2) the effects of using these various products in combination. There are many unanswered questions about the science, safety, and quality of products containing CBD.

We especially want to learn more about the effects of CBD during pregnancy and while breastfeeding, including, for example, whether and to what extent the presence of CBD in human milk harms the breastfed baby or the mother’s milk production.

Has FDA approved any CBD products and are there any benefits?

FDA has not approved any CBD products except for one prescription drug to treat rare, severe forms of seizure disorders in children. It is still unclear whether CBD has any other benefits.

Other than the one approved prescription drug, CBD products have not been evaluated or approved by FDA for use as drug products. This means that we do not know:

  • if they are safe and effective to treat a particular disease
  • what, if any, dosage may be considered safe
  • how they could interact with other drugs or foods
  • whether they have dangerous side effects or other safety concerns

The clinical studies that supported the approval of the one available CBD drug product identified risks related to the use of CBD, including liver toxicity (damage), extreme sleepiness, and harmful interactions with other drugs.

What about hemp seeds?

FDA recently completed an evaluation of some hemp seed-derived food ingredients and had no objections to the use of these ingredients in foods. THC and CBD are found mainly in hemp flowers, leaves, and stems, not in hemp seeds. Hemp seeds can pick up miniscule amounts of THC and CBD from contact with other plant parts, but these amounts are low enough to not raise concerns for any group, including pregnant or breastfeeding mothers.

What should you remember about using cannabis or cannabis-derived products?

If you are considering using cannabis, or any products containing THC or CBD, you should be aware of the following:

  • FDA strongly advises that during pregnancy and while breastfeeding, you avoid using CBD, THC, or marijuana in any form.
  • Although many of these products are being sold, FDA has not approved these products, other than one prescription CBD drug product and two prescription drug products containing dronabinol, a synthetic version of THC (which are approved to treat certain side effects of HIV-AIDS or chemotherapy). All three of these prescription products have associated risks and side effects.
  • Always talk with your doctor, nurse, or pharmacist before taking any medicines, vitamins, or herbs while pregnant or breastfeeding.

Do not put yourself or your baby at risk by using cannabis products while pregnant or breastfeeding. Check out these links to learn more about cannabis, marijuana, CBD, and THC, and about taking medicines while you are pregnant.

  1. https://drugabuse.gov/publications/research-reports/marijuana/can-marijuana-use-during-pregnancy-harm-baby
  2. Dalterio SL, deRooij DG. Maternal cannabinoid exposure. Effects on spermatogenesis in male offspring. Int J Androl. 1986 Aug;9(4):