FDA & CBD
We encourage all who use or will use CBD to consult with your Doctor before using. Although many claims of success have been reported- it is not proven medically or approved by the FDA. We have provided FDA viewpoint below-and encourage all to follow the rulings of the FDA as they are released.
You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, pet food, and other animal health products.
The U.S. Food and Drug Administration (FDA) recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The Agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.
The recent increase in the number of CBD products may be because of both recent changes in state law, and because the 2018 Farm Bill removed hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act. However, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.
Other than one prescription drug product to treat rare, severe forms of epilepsy, the FDA has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.
alk with their veterinarians about appropriate treatment options for their pets.
The FDA is Continuing to Evaluate the Regulatory Frameworks for Products Containing Cannabis and Cannabis-Derived Compounds
The FDA continues to believe the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.
We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is currently illegal to market CBD this way.
The FDA is currently evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.
The FDA is committed to sound, science-based policy. The FDA is raising these safety, marketing and labeling concerns with you now because we want you to know what we know.
Today’s Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make smart choices about CBD products. Also, as the regulatory pathways are clarified we will take care to notify all stakeholders as quickly as possible.
More information is available at: FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers.