DISTRICT OF COLUMBIA: The U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). All five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions. The warning letters include CBD products that are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food, and the impermissible marketing of CBD products as dietary supplements. Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye.
“The FDA’s first priority is to protect the health and safety of Americans. Many questions remain regarding the science, safety, effectiveness and quality of products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “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 the greatest risk of harm to the public.”
The warning letters were issued to:
- Bee Delightful
- G&L Wellness (C Better Daily)
- New Leaf Pharmaceuticals
- NextL3vel Services Group, LLC doing business as This Stuff Is Good For You
- Wellness BioSciences
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food, and some of the products were impermissibly marketed as “dietary supplements.”
The products that are the subject of the letters issued today have not gone through the FDA drug approval process and therefore are considered unapproved new drugs. It is not known whether they are effective for the uses claimed in labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of these unapproved CBD-containing drug products has not been subject to FDA review as part of the human or animal drug approval processes, so it is not known what the manufacturing conditions of, or contaminant levels in these products may be.
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 or animals, is a drug. New human and animal drugs must be approved by the FDA or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review, before they can be legally marketed as drugs. CBD was not an ingredient considered under the OTC Drug Review.
The FDA has not approved any CBD products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in human patients. CBD has not been approved as a food additive and does not meet the statutory definition of a dietary supplement.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.