We have discussed a public hearing that FDA held on May 31, 2019 to obtain scientific data and safety information on the wide array of FDA-regulated products already on the market that contain cannabidiol (CBD).  This hearing was part of FDA’s effort to explore whether it would be possible to develop a regulatory pathway for CBD-containing foods and dietary supplements to be lawfully marketed.  Subsequently, FDA stepped up its CBD enforcement action last year against a wide array of CBD-containing products making disease and health-related claims, as we reported.  When Congress appropriated funds for hemp/CBD market surveillance activities in December 2019, it directed FDA to report on progress toward obtaining and analyzing data to help determine a policy of enforcement discretion and a process in which CBD will be evaluated for lawful use in FDA-regulated products.

FDA’s Report to Congress was publicly revealed on March 5, 2020 and indicated that little actual progress has been made.  The most significant development is that FDA is considering developing a risk-based enforcement policy that could possibly clarify FDA’s enforcement priorities.  Given the widespread availability of such products, however, an informal policy of enforcement discretion has been in place for some time.  Progress toward quickly providing for the lawful use of CBD in dietary supplements and conventional food is not likely, however, as the report makes it clear that FDA remains concerned about the risks of CBD, which include potential liver injury, interactions with other drugs, male reproductive toxicity, and side effects such as drowsiness.  To facilitate obtaining data that would make it possible to determine whether there may be any safe conditions of use for CBD in any FDA-regulated consumer products, aside from the one currently FDA-approved prescription drug use, FDA announced that it will reopen the docket that was created following the May 31, 2019 hearing and that it is working on a process whereby companies can provide proprietary information on specific products on a confidential basis.

FDA’s report was only slightly more hopeful about the prospect of future rulemaking or an enforcement policy on the use of CBD in dietary supplements, as compared to conventional foods, for which an eventual FDA clearance seems particularly challenging.  On the whole, the report emphasizes significant obstacles that include FDA’s ability to provide adequate regulatory oversight, workload considerations, and how to make consumers aware of limitations in FDA’s oversight of dietary supplements that may be particularly significant for CBD-containing products, as well as tangential safety concerns like heavy metal contaminants and other impurities or undeclared ingredients.  As to consumer awareness issues, the report also reiterates concerns about false marketing claims for CBD products, cumulative exposure, and use by vulnerable populations. An FDA Statement for the public was issued concurrently with the disclosure of the congressional report to educate consumers on the FDA status of CBD-containing products and warn of potential health risks.