The FDA has issued warning letters to two companies selling OTC CBD products for pain relief. The items are labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letters address the illegal marketing of unapproved drugs labeled as containing CBD.
The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and these products do not meet the requirements to be legally marketed without an approved new drug application. CBD has known pharmacological effects on people, with demonstrated risks, so it can’t be legally marketed as an inactive ingredient in OTC drug products that are not approved by the FDA.
The letters also cite substandard manufacturing practices, including the failure to comply with current good manufacturing practices. The companies that received the letters are Honest Globe Inc. and Biolyte Laboratories LLC.
FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. said in a statement, “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. 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. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”
The products that are the subject of the warning letters have not gone through the FDA drug approval process, so are considered unapproved new drugs. There has been no FDA evaluation of effectiveness, what an appropriate dose may be, how they could interact with other FDA-approved drugs, or whether there are dangerous side effects or other safety concerns.
Under the FD&C Act, any product “intended to diagnose, cure, mitigate, treat, or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug.” OTC drugs must be approved by the FDA or meet requirements for marketing without an approved new drug application, regardless of whether CBD is represented on the label as an active or inactive ingredient.
The FDA has not approved any CBD-containing drug products other than one prescription drug. That drug is used for the treatment of seizure associated with tuberous sclerosis complex, Lennox-Gastaut syndrome, and Dravet syndrome in human patients.
