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By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner

Over a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis. However, we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds, including potential safety risks for people and animals. At the U.S. Food and Drug Administration, we see these knowledge gaps as an opportunity to develop new ways of building the science to inform public health decisions.

The FDA evaluates CBD just like any other substance we regulate, under a regulatory framework defined by law and with rigorous scientific evidence as a basis for both our regulatory approach and information we communicate. We’ve consistently communicated concerns and questions regarding the science, safety, and quality of many of these products based on currently available evidence. We still don’t have clear answers to important questions such as what adverse reactions may be associated with CBD products and what risks are associated with the long-term use of CBD products. Better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health.  

We see an important public health opportunity in using novel sources of data and rigorous analytical methods to build a more robust base of scientific evidence on the safety profile and use of CBD products. The FDA is uniquely situated to contribute its expertise in evaluating data from different sources to inform regulatory decision-making. We think that real-world data (RWD) on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in our understanding.

What follows is a brief overview of our work on CBD and a framework for building a more robust evidentiary foundation to inform public health decisions. 

Background: FDA’s Ongoing Work on CBD

In December 2018, a change in the law made the FDA’s work on CBD issues particularly important. The Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) removed hemp from the definition of marijuana in the Controlled Substance Act (CSA). This means that cannabis plants and derivatives that contain no more than 0.3 percent delta-9-tetrahydrocannabinol (THC) on a dry weight basis are no longer controlled substances under the CSA. While hemp that meets this definition is no longer controlled under the CSA, FDA-regulated products containing hemp must still meet applicable requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act.

photo of Stephen M. Hahn, M.D.
Stephen M. Hahn, M.D.

The FDA has approved one drug, Epidiolex, that contains a highly-purified form of CBD for the treatment of seizures associated with Lennox‑Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older. During review of the marketing application for Epidiolex, the FDA identified certain safety risks, including the potential for liver injury and for adverse reactions caused by the interaction between Epidiolex and other medications. These risks are communicated in the approved labeling for Epidiolex.

Although the 2018 Farm Bill expressly did not change the FDA’s authorities regarding the regulation of CBD and other cannabis derivatives, the fact that these substances are no longer controlled substances has triggered increased interest in and availability of these ingredients for commercial development. Our website provides additional information about the agency’s activities related to CBD. The FDA’s work to develop better information on CBD and on the CBD market has been focused in the following areas: engagement with stakeholders, including on the development of data on CBD use and safety; and, sampling and testing by the FDA of CBD products in the market.

Engagement with Stakeholders on CBD Issues

When the 2018 Farm Bill was enacted, we recognized the importance of engaging with the community of stakeholders interested in CBD. We held a public hearing in May 2019 and issued a call to stakeholders to work with the agency to develop high-quality data on CBD. The FDA re-opened the May 2019 public hearing docket, and will keep it open in the future as one mechanism for stakeholders to share data. In July 2020, we gathered stakeholder and industry input regarding the challenges surrounding quality, safety, and monitoring of the current marketplace. We also held a multidisciplinary scientific conference in November 2020 to provide further insight into the scientific evidence supporting the presence or absence of sex and gender differences in use and responses to CBD and other cannabinoids. The FDA also conducts regular listening sessions with stakeholders willing to share their perspective and data with us. 

As we continue to evaluate the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether any new FDA regulations may be warranted, the FDA continues to work actively with drug developers through the investigational new drug, drug review, and drug approval processes. The FDA’s work in this area involves both meetings with drug developers to provide advice that is specific to the development of a proposed product, as well as the development of guidance documents on high-priority regulatory and scientific issues. For example, the FDA recently published a draft guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” which, when final, will represent the agency’s current thinking on sources of cannabis, resources for information on quality considerations, and percent delta-9 THC calculation. The FDA is evaluating comments submitted to the agency regarding this draft guidance.

FDA’s CBD Product Sampling and Testing Activities

Sampling and testing of marketed CBD products is another way that the FDA has gathered more information about the safety profile of these products. This is an important component of the FDA’s work because little is known about the amounts of CBD and various related cannabinoids, as well as the occurrence of toxic elements, pesticides, other possible chemical contaminants, and adulterants, that may be present in CBD products that are marketed to consumers. We are testing CBD product samples in the following ways:

  • The FDA at times tests products as part of its compliance and enforcement activities. For example, in connection with several warning letters sent to firms for marketing unapproved new drugs that allegedly contain CBD, the agency tested the cannabinoid content of certain products and many were found to not contain the levels of CBD they claimed to contain. The FDA made the results of such testing publicly available.  
  • The FDA also designed surveys of the market and currently is conducting a two-phase marketplace sampling and testing study. The first phase involved a small sampling and analysis study (~200 samples) conducted by the agency. While the data collected so far are from a limited sample size and are insufficient to draw definitive conclusions regarding the prevalence of results in marketed products, general observations indicate fewer than half of the tested products which presented label claims contained CBD at concentrations within 20% of their claimed amount and some products contained the psychoactive, intoxicating cannabinoid THC. The FDA has recently <a…