In doing so, FDA said it has determined that the firm’s “Teeth/TMJ – Essential Oil + CBD Infusion,” “Ears – Essential Oil + CBD Infusion,” “Hemp Capsules, 750 mg,” “Hemp Infused Body Butter,” and “Hemp Oil” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). FDA also said that these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA also noted that introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act.
As FDA stated in an announcement regarding a warning letter on July 23, 2019, “while we recognize the potential opportunities and significant interest in drug products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority,” 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.
FDA noted: “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. With the exception of Dronabinol, Epidiolex, Marinol and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population.”
FDA said that it is “particularly concerned” that Rooted Apothecary is marketing unapproved new drugs for uses in infants and children.