Science forms the basis for decisions at the U.S. Food and Drug Administration (FDA) and is paramount when it comes to making decisions that will impact the health and safety of the American public. We apply this rigorous, science-based approach to matters large and small that come before the Agency — including with respect to products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD).
We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise. At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.
The FDA’s approach to cannabis and cannabis-derived compounds has been consistent. We treat substances derived from cannabis just like we do any other substances, and they are subject to the same authorities as any other substance. That said, some other relevant laws have changed, and so has the market.
On the state level, some jurisdictions have eliminated certain prohibitions on cannabis or cannabis-derived compounds. On the federal level, the Agriculture Improvement Act of 2018 (Farm Bill) removed cannabis and cannabis derivatives that are very low in THC from the definition of marijuana in the Controlled
Substances Act (CSA). At the same time, that legislation specifically preserved the FDA’s responsibility over such products.
As these other laws have changed, and as more cannabis products come to the market (whether lawfully or otherwise), the FDA’s role is becoming more practically relevant to many affected stakeholders. We recognize the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward. This includes being transparent and up-front with the public and all of our stakeholders as we continue to collect information and data to deepen our understanding of CBD.
Under the statutory authorities that the FDA has the responsibility to administer, the relevant legal requirements vary depending on which type of product we’re talking about. For example, if a product is being marketed as a drug — meaning, for example, that it’s intended to have a therapeutic effect such as treating a disease — then it’s regulated as a drug, and it generally cannot be sold without FDA approval (or, in the case of an over-the-counter drug, an FDA monograph). Drugs have important therapeutic value, and it is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis.
Food, including dietary supplements, is regulated differently, but with the same overarching goal of protecting consumers. Among other things, it is currently illegal to put into interstate commerce a food to which CBD has been added, or to market CBD as, or in, a dietary supplement. Essentially, the relevant statutory provisions prohibit these uses of CBD because CBD was the subject of substantial clinical investigations into its potential medical uses before it was added to foods (including dietary supplements), and, separately, because CBD is the active ingredient in Epidiolex, an FDA-approved prescription drug product to treat rare, severe forms of epilepsy.
When dealing with complex questions like those posed by CBD, the FDA’s top priority is always our mission of protecting and promoting public health. The Agency is committed to science-based decision making when it comes to CBD, while also taking steps to consider if there are appropriate regulatory pathways for the lawful marketing of CBD, outside of the drug setting.
