More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”).
The Food and Drug Administration (FDA) has been exploring potential regulatory pathways for CBD but it has yet to engage in rulemaking or issue guidance that would provide a clear framework under which FDA could maintain oversight over CBD to ensure that its use in a range of products is safe.
Last week, FDA posted a letter it recently sent to a dietary supplement company, which explained its concerns about the adequacy of safety evidence the company presented to demonstrate that the use of CBD as a new dietary ingredient will reasonably be expected to be safe. This latest message adds to the confusion surrounding the legal status of CBD and raises questions about whether FDA will continue to exercise enforcement discretion with regard to products containing CBD, particularly dietary supplements.