FDA Sends Warning Letters Citing Illegal Promotion of CBD Products

FDA has sent warning letters to companies selling products that contain cannabidiol (CBD). The agency says the companies have illegally marketed unapproved CBD products, claiming that they can be used to treat medical conditions. The companies that received the warning letters are Bee Delightful, G&L Wellness (C Better Daily), New Leaf Pharmaceuticals, NextL3vel Services Group, LLC (which is also known as This Stuff Is Good For You), and Wellness BioSciences.

In a press release dated Dec. 22, 2020, the agency stated that these companies’ products have not undergone the FDA drug approval process, so it is not known whether they are effective or safe. In addition, FDA noted that it has not reviewed the manufacturing processes that they use to make these products. “Under the FD&C Act [Federal Food, Drug, and Cosmetic 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 agency stated in the press release.

“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,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, commented in the press release. “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,” she stated in the release.