CBD

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

Overview
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.
2
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
   supplements.
   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
12/31/2019.
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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.

4. 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.
5. 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.
6. 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.
7. 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.
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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.