In a recent webinar organized by the Alliance for a Stronger FDA, a top policy and legislation official from the U.S. Food and Drug Administration (FDA) provided insight to the agency’s approach to regulating cannabidiol (CBD) and kratom in foods and dietary supplements.

In the past year, FDA has acknowledged the need to design a novel regulatory pathway for CBD products after an internal working group concluded that there are notable health concerns that exist around CBD consumption, especially long-term use. The agency expressed that it does not intend to pursue rulemaking allowing CBD in foods or supplements, but FDA would be willing to work with U.S. Congress on the matter of forging a new framework for CBD oversight.

In the recent webinar, Kimberlee Trzeciak, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs, affirmed FDA’s stance that, based on current knowledge, CBD products would not be able to meet the safety standards that the agency has in place for foods and dietary supplements. Nonetheless, at retail stores across the nation, consumers are still able to purchase products containing CBD, kratom, and similar substances that exist within a regulatory gray area. Therefore, FDA recognizes the importance of leveraging its available regulatory tools to ensure that such products are going to be marketed in a way that consumers are clearly aware of what the product is and what is in it, and to make sure sure that FDA has basic information about the marketplace.

“For example,” Ms. Trzeciak said, “how can we ensure that the Agency knows if there are adverse events that are being reported, so we can identify those trends, making sure that the product is being manufactured or produced in a way that's safe and quality?” She shared other important considerations of designing legislation for CBD and other similar substances being used in foods and as supplements such as clear labeling to ensure children are not consuming these products, as well as ensuring that FDA is aware of the manufacturers of these products.

“I think [FDA has] a lot of experience from the other products that we have regulated about which basic regulatory tools would be most beneficial, but we also need to have a better sense from [Congress] and from stakeholders about where lines need to be drawn in terms of the safety of the products. What level of oversight do we want for them?” said Ms.  Trzeciak. “I think one of the most important things, though, is that there is, I would hope, common ground on wanting to make sure that consumers are educated about what they are taking.”