FDA Enforcement: There’s Nothing Inactive About CBD and “FDA Registered” Is Misleading

On Monday, FDA announced two warning letters issued to makers of topical CBD products labeled as OTC drugs. Amidst a backdrop of facility inspections that revealed significant good manufacturing compliance concerns, the most important takeaways in this round of CBD enforcement are as follows: FDA does not think that CBD is an appropriate inactive ingredient in OTC drugs, a position that we do not believe the agency has previously articulated publicly. In addition, reaffirming a position that...
By: Kelley Drye & Warren LLP

Array