On January 26, 2023, the Food and Drug Administration (FDA) announced that existing regulatory frameworks are not appropriate for cannabidiol (CBD) products. The agency called on Congress to develop a regulatory pathway that “balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”
In reaching the decision, the FDA reasoned that “FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products,” noting that CBD raises various safety concerns, including potential for harm to the liver and male reproductive system, and possible interactions with certain medications.
The FDA denied three citizen petitions requesting the agency to undergo a rulemaking to allow the use of CBD as dietary supplements, reasoning that current food and dietary supplement authorities provide limited tools for managing the risks associated with CBD products. The agency recommended clear labels, prevention of contaminants, CBD content limits, and other safeguards, such as minimum purchase age.
Read the full announcement here.