Last week, the Food and Drug Administration (“FDA”) released its latest round of warning letters to “cannabidiol” (“CBD”) companies. In letters dated March 15 and March 18, the FDA took issue with the sale and marketing of topicals commonly known as “over-the-counter” (“OTC”) (i.e., non-prescription) drug products that listed CBD as an “inactive ingredient,” yet represented the substance as having purported pharmacological properties, such as relief pain.
Although this latest FDA’s enforcement action is consistent with previously issued warning letters, all of which were triggered by the use of unsubstantiated medical claims (see here, here and here for some examples), this latest round of warning letters also suggest that the agency strongly disapproves of the use of CBD in this category of topicals. Specifically, the FDA deemed the OTC drug products infused with CBD as “unapproved new drugs” because these products were not reviewed and approved for their safety and effectiveness before being introduced in interstate commerce and because they were not manufactured in compliance with applicable current good manufacturing practices (cGMPs).
If you follow our blog, you have read us explain that “topical products,” more precisely “cosmetics,” are the least risky category of products with which CBD may be