In response to a recent directive from Congress, the U.S. Food and Drug Administration (FDA) has released a report that describes “the agency’s progress toward obtaining and analyzing data to help determine a policy of enforcement discretion and the process in which CBD meeting the definition of hemp will be evaluated for use in products.” The report outlines a variety of actions taken or being considered by the FDA to advance the potential regulatory pathways for CBD.
Reiterating many of its long-standing positions, the FDA stood firm and expressed its primary concern for consumer safety and lack of scientific data on CBD products. The report maintains the FDA’s hands-off approach to CBD in cosmetics and does little to advance the agency’s stance on CBD in human and animal drugs and foods. But, for perhaps the first time, the FDA signaled a policy shift and potential regulatory pathway for CBD in dietary supplements.
Recognizing its authority to create an exemption through rulemaking that would allow CBD products to be sold as dietary supplements, the FDA will continue evaluating the differences between full-spectrum and broad-spectrum products compared with isolate products. This shift hints at a regulatory pathway that the industry has suspected for some time.