Less than a week after the Federal Trade Commission (FTC) announced law enforcement action against six companies for unapproved marketing practices, the United States Food and Drug Administration (FDA) has issued warning letters to five companies for marketing cannabidiol (CBD) products in a way that violates the Federal Food, Drug, & Cosmetic Act (FD&C Act).
The FDA issued warning letters to Bee Delightful, G&L Wellness (C Better Daily), New Leaf Pharmaceuticals, NestL3vel Services Group, LLC (This Stuff Is Good For You), and Wellness BioSciences.
According to the FDA, the five companies illegally marketed CBD products with claims of their ability to treat medical conditions.
Both the FTC and the FDA have previously sent warning letters to CBD companies for unapproved marketing practices.
In some cases, there were further violations involving the addition of CBD to food.
CBD is currently unapproved as a food additive and dietary supplement.
The FDA says that the five new letters include products that are especially concerning in terms of public health due to their administration routes through the nose, eyes, and lungs.
Additionally, the letters address CBD-infused food and the impermissible marketing of CBD products as dietary supplements.
Two of the letters also address CBD products that the FDA says were illegally marketed for pets.
“The FDA’s first priority is to protect the health and safety of Americans,” says FDA Principal Deputy Commissioner Amy Abernathy, 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 FD&C Act specifies that any product intended to affect the structure or function of the human body, or diagnose, cure, mitigate, treat, or prevent a disease, is considered a drug.
The FDA considers the products addressed in the letters to be unapproved new drugs as they have not gone through the approval process.
The FDA says that it is unknown whether the products are effective for the uses claimed on the labeling, what the appropriate dose is, if they might interact with FDA-approved drugs, or whether there are potential side effects or safety concerns.
Since the FDA has not reviewed the production process, the Administration says that it is unknown what the manufacturing conditions are like or how high contaminant levels in the products might be.
Before a company markets a new drug for animals and humans, it must have FDA approval or conform to a monograph for a particular drug category, as established by the FTC’s Over-The-Counter Drug Review.
The only CBD product that has gained FDA approval so far is G.W. Pharmaceutical’s Epidiolex formulation, which has undergone the full federal trial and approval process.
Epidiolex is intended to treat tuberous sclerosis complex, Lennox-Gastaut syndrome, and Dravet syndrome in human patients.
The five companies contacted by the FDA have 15 working days to respond with how they plan to address their unapproved marketing issues or provide reasoning and supporting information as to why they believe their products are not in violation of the law.
According to the FDA, failure to properly address the violations may result in legal action, including seizure of product and injunction.
