The Food and Drug Administration (FDA) has issued warning letters to Honest Globe Inc and Biolyte Laboratories LLC for illegally selling over-the-counter (OTC) unapproved products labeled as containing cannabidiol (CBD).

The products described in the warning letters are being marketed as topical pain therapies, though none have actually been evaluated by the FDA. According to the Agency “a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient.”

Currently, there are no CBD products that have met the legal requirements for nonprescription use. Only one prescription drug, Epidiolex (cannabidiol; Greenwich Biosciences), has received FDA approval for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “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.”


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Reference

FDA warns companies illegally selling over-the-counter CBD products for pain relief. [press release]. Silver Spring, MD: US Food and Drug Administration; March 22, 2021.