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Cannabidiol: Existing Regulatory Framework Inadequate, FDA Says

6 February, 2023

FDA issues response to three Citizen Petitions related to CBD and dietary supplements and concludes that existing regulatory frameworks for foods and supplements are not appropriate for Cannabidiol.

On January 26, 2023, the FDA denied the requests in three citizen petitions (from the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA)) that the FDA issue a regulation that would allow cannabidiol (CBD) products to be marketed as dietary supplements. Such a regulation would be needed in order to provide a potential pathway for CBD products to be lawfully marketed as dietary supplements, because a provision in the law prohibits the marketing of certain drug ingredients as dietary supplements. The FDA’s responses explain that the Agency does not intend to initiate such a rulemaking, because in light of the available scientific evidence, it is not apparent how CBD products could meet the applicable safety standard for dietary supplements.

In addition, the FDA issued a general statement that explains that the agency does not consider the existing dietary supplement and conventional food pathways to be appropriate for CBD and that the FDA is interested in working with Congress to develop a new pathway that balances consumers’ desire to access CBD products with the regulatory oversight necessary to better manage the risks these products present. According to the FDA, the use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant. The FDA will continue to take action against CBD and other cannabis-derived products to protect the public. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.