On March 22, the U.S. Food and Drug Administration (FDA) stated that it has issued warning letters to two companies for selling topical pain relief products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, the warning letters addressed the illegal marketing of unapproved drugs labeled as containing CBD. The FDA stated that it has not approved any over-the-counter (OTC) drugs containing CBD, and that none of these products meet the requirements to be legally marketed without an approved new drug application.
“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,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “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. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety.”
The FDA issued warning letters to:
- Honest Globe Inc.
- Biolyte Laboratories LLC
Attorney Steven Shapiro, Of Counsel, Rivkin Radler, LLP, commented, “While the warning letters discuss CBD as an inactive ingredient generally, neither warning letter discusses the potential for CBD as an inactive ingredient intended to provide a cosmetic benefit apart from the active ingredient drug indication. Is it possible to include CBD as a topical cosmetic ingredient? IS FDA changing its position? FDA may have just made it kind of complicated. We know that there is evidence that cannabidiol has some cosmetic benefits, including as a skin conditioner. (See International Cosmetic Ingredient Dictionary and Handbook, Sixteenth Edition 2016, p. 557). FDA has exercised enforcement discretion to permit inactive ingredients in OTC topical products to make specific cosmetic claims, and such claims are frequently made for soothing aloe or moisturizing lanolin in various topical OTC Monograph products. As with everything involving CBD, the question of CBD in topical products is another complicated question that will need to be carefully considered and closely watched.”
The FDA has requested written responses from the companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.