FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
Statement from Commissioner of Food and Drugs – Food and Drug Administration
Stephen M. Hahn M.D. at March 05, 2020
Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.
Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.
Educating the Public About Potential Risks of Using CBD
We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.
But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.
We remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.
In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.
We will continue to expand our educational efforts on this front. This includes consumers broadly, specific populations where there are additional, important health considerations, as well as health care professionals who must understand these risks when talking to their patients. We will also continue to update our online resources for consumers, researchers and industry, as well as sustain multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives.
SEE OUR ARTICLE ON THE ROLE OF EXCIPIENTS IN CBD PRODUCTS