FDA sends warning to companies selling unapproved CBD products

The warning letters were issued to two companies illegally selling over-the-counter cannabidiol (CBD) products for pain relief.

Cartoon of hands opening an envelope and the letter inside having a big exclamation mark (indicating a warning)

The US Food and Drug Administration (FDA) has issued warning letters to two companies, Honest Globe Inc. and Biolyte Laboratories LLC, for the illegal marketing of unapproved drugs labelled as containing cannabidiol (CBD).

The FDA has not approved any over-the-counter (OTC) drugs containing CBD and stated that none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.

The regulator added that it 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 Federal Food, Drug, and Cosmetic Act (FD&C Act).

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, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law. This includes drug products containing CBD, regardless of whether CBD is represented on the labelling as an active ingredient or an inactive ingredient.

The FDA stated that it has only approved a single CBD-containing prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.

The agency has requested that Honest Globe and Biolyte provide written responses within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. It added that failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

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