FDA indicates need to better regulate CBD products and plans to work with Congress on new rules

CBD products will require a new regulatory pathway, the US Food and Drug Administration said Thursday, and the agency plans to work with Congress to develop a strategy.

It was already illegal to market products containing cannabidiol, known as CBD, as dietary supplements, and the agency has highlighted concerns around safety and unknowns about CBD.

The FDA now says CBD products cannot be considered dietary supplements or food additives, citing the findings from a working group review of studies, scientific literature and other information submitted by the public. This decision directly denies three citizen petitions with this request.

“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods,” FDA Principal Deputy Commissioner Dr. Janet Woodcock said in a statement.

CBD is part of the cannabis plant that does not cause the high associated with marijuana use. Some research has found that it can ease pain, and the FDA has approved one drug with CBD to treat rare, severe forms of epilepsy.

The FDA faces a unique situation with CBD, says Christopher McCurdy, president of the American Association of Pharmaceutical Scientists. Because the products have become so popular and proliferated so much, there’s much more anecdotal evidence than scientific evidence about how they work.

“The important thing to take away is that they’re trying to balance the consumer desire for the products with a regulatory framework to ensure the safety. That’s what the FDA’s role is,” said McCurdy, who is also a professor at the University of Florida’s College of Pharmacy.

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