WASHINGTON — The US Food and Drug Administration on Dec. 22 issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. The five companies illegally were marketing unapproved CBD products claiming to treat medical conditions, according to the FDA.
“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,” said Amy Abernethy, MD, PhD, principal deputy commissioner for the FDA. “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 five companies were Bee Delightful, which sells Canna Bees Rescue Blend; G&L Wellness, LLC, which sells C Better Daily eye drop products for humans and pets; New Leaf Pharmaceuticals, LLC, which sells Rhinodol CBD intranasal products; NextL3evel Services Group, LLC doing business as This Stuff Is Good For You, which sells CBD products for humans and pets; and Wellness BioSciences RX, which sells inhalers, soft gels, oil drops and balm that contain CBD.
CBD is an extract found in two kinds of cannabis: marijuana and hemp. More information on the warning letters may be found here.
Since the products mentioned in the letters have not gone through the FDA drug approval process, the FDA considers them unapproved new drugs. 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, according to the FD&C Act. The FDA has approved one CBD product, Epidiolex, as a drug for the treatment of seizures.
The FDA pointed to Bee Delightful’s claims for honey as well as CBD. Bee Delightful claimed honey kills unwanted bacteria and fungus, helps with digestive issues, and soothes a sore throat. The company’s CBD claims included may reduce pain from diseases like multiple sclerosis and rheumatoid arthritis, may reduce anxiety and depression, may alleviate cancer treatment symptoms, may reduce acne, and may benefit heart health.
G&L Wellness claimed its eye drop products were anti-inflammatory and anti-bacterial. New Leaf Pharmaceuticals claimed CBD could help with post-traumatic stress disorders (PTSD) and rheumatoid arthritis.
NextL3evel Services Group claimed experts were recommending the study of CBD for use in anti-viral therapies, including COVID-19 treatment. The company also claimed its eye drops were “excellent for ocular degeneration or disorders such as but not limited to glaucoma, cataracts, diabetic retinopathy.” Wellness BioSciences RX claimed research has linked CBD to better sleep, pain relief, and easing PTSD and anxiety.