FDA Sends Warning Letters for Illegal CBD Products

December 22, 2020
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

The 5 companies issued letters will have 15 days to submit a compliance plan.

The US Food and Drug Administration (FDA) is warning companies for selling illegal cannabidiol (CBD) products.

On Dec. 22 the agency issued 5 warning letters to companies for selling CBD in a way that violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) by marketing unapproved CBD products claiming to treat medical conditions.

The products in questions are particularly concerning to the public because of the route of administration, including nasal, ophthalmic, and inhalation. The FDA also addresses violations relating to the addition of CBD to food and the impermissible marketing of CBD products as dietary supplements.

In 2 of the letters, the FDA cites 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, MD, PhD, in a statement. "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 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, and Wellness BioSciences.

The FDA has previously sent letters to other companies for illegally selling unapproved CBD products claiming to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

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, with failure to adequately address the violations could result in legal action, including product seizure and/or injunction.