FDA, FTC Warn CBD Company for Unsubstantiated Claims

The U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have announced a joint warning letter sent to Rooted Apothecary LLC focused on the potential benefits that the company claimed its cannabidiol (CBD) products could provide. “The Agency continues to be concerned about the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses without having been reviewed for safety and effectiveness by the FDA as is required by law and to protect the public health,” the letter states. “There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD. Without this information, we are unable to ensure that these products will not cause harm to people who use them.”

The agencies warn that Rooted Apothecary is marketing unapproved drugs because it advertises its CBD-infused products as helping to diagnose, cure, mitigate, treat or prevent a number of conditions, including pain associated with teething in children. FTC also noted that the marketing likely lacks “rigorous scientific evidence sufficient to substantiate the claims” in violation of the FTC Act.