Report to the U.S. House Committe on Appropriations and the U.S. Senate Committee on Appropriations
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 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.
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:
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.
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:
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.
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.
If you are considering using cannabis, or any products containing THC or CBD, you should be aware of the following:
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.