FDA CBD Update

The US Food and Drug Administration has announced a new regulatory pathway is needed to manage risks from a growing cannabidiol (CBD) market in the US.

FDA concluded that a new regulatory pathway for CBD is “needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” The agency said it prepared to work with Congress on this matter. The FDA also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

As a reminder, the FDA has previously said, that the use of CBD in foods and dietary supplements runs afoul of what is called the preclusion provisions of the Food Drug and Cosmetic Act. Furthermore. Additionally, the FDA has said that CBD is not a recognized, active or inactive ingredient in pharmaceuticals with the exception of Epidolex.

It will now be up to the US Congress to pass legislation creating a new pathway for CBD. In the meantime, FDA has said it will, “continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate.”

The announcement today poses a risk of FDA enforcement for products currently on the market. There is also a risk that the conclusions on safety and benefits announced today (e.g., “we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm”) could also be used by consumers to take private action.