FDA Is “Actively” Considering Regulating CBD and Kratom

An official with the Food and Drug Administration (FDA) says the agency is  “actively” exploring a regulatory framework for cannabidiol (CBD), with plans to prioritize the move in the coming months.

At a webinar hosted by Alliance for a Strong FDA, Kimberlee Trzeciak, who serves as the FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs, says that either this year or next the agency is planning to establish “an appropriate regulatory framework for CBD.”

“In almost every neighborhood you go to, you can see stores on the corners that are marketing CBD and kratom and others,” said Trzeciak. “And one of the things that we have been thinking through here at FDA, using CBD as an example, is what does the regulatory framework for those products look like?”

She continues by saying that “Based on what we know about CBD in particular, we do not think that those products would be able to meet the safety standards that we have in place for foods and dietary supplements today. What can we do in terms of regulatory tools to ensure that this product is going to be marketed that consumers are clearly aware of what the product is, what is in it and making sure that we have basic information about the marketplace?”

Trzeciak said she likes to think “of it as the common regulatory tool that we have across the other products that we regulate”, while noting that FDA plans to “work with Congress on this effort”.

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