The U.S. Food and Drug Administration (FDA) reports the issuance of warning letters to two companies who are selling pain relief products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic (FD&C) Act. The FDA has not approved any over-the-counter drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters to Honest Globe, Inc. of Santa Ana, Calif., and to Biolyte Laboratories, LLC of Grand Rapids, Mich. explain that their products cannot be legally marketed with CBD as an inactive ingredient in an over-the-counter drug without review and approval of the FDA. This includes Honest Globe’s Elixicure Original and Lavender Pain Relief with CBD as well as Biolyte’s Silver Gel products, Therapeutic Pain Gel, Pain Relief Cream and Magnesium Oil Spray. “The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” says FDA Principal Deputy Commissioner, Dr. Amy Abernathy. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved CBD products may have dangerous health impacts and side effects.” She adds they are continuing to focus on exploration of pathways for CBD products to be lawfully marketed and to educate the public about safety. The FDA has requested written response from the companies about plans for addressing the violations or their reasoning behind why they believe the products are not in violation of the law. Failure to comply may result in legal action, including product seizure and/or injunctions.
