FDA Warns Cos. Selling Unapproved Over-the-counter Cannabidiol

FDA Warns Cos. Selling Unapproved Over-the-counter Cannabidiol

March 30, 2021

Two companies have been warned by the U.S. Food and Drug Administration for illegally selling over-the counter pain relief products labeled as containing cannabidiol or CBD.

In a statement, the health regulator said it issued warning letters to Honest Globe Inc. and Biolyte Laboratories LLC for selling the products listing CBD as inactive ingredient, and in ways that violate the Federal Food, Drug, and Cosmetic Act or FD&C Act.

None of these products meet the requirements to be legally marketed without an approved new drug application, the agency said.

As per the letters, CBD has known pharmacological effects on humans, and 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.

The FDA said it has not approved any over-the-counter or OTC drugs containing CBD. The only CBD-containing approved drug is a prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.

The warning letters also cite substandard manufacturing practices.

The agency had sent warning letters to other companies earlier for illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

FDA Principal Deputy Commissioner Amy Abernethy,, “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects.”

Both affected companies are asked to submit written responses within 15 working days stating how they will address these violations, among others.

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