FDA Warns Companies Selling CBD Pain Relief Products

FDA warns companies for selling products listing CBD as inactive ingredient

(RxWiki News) The US Food and Drug Administration (FDA) has issued warning letters to two companies selling products that contain cannabidiol (CBD).

These companies listed CBD in their products in a way that violates the Federal Food, Drug, and Cosmetic Act (FD&C Act), according to the FDA.

The companies the FDA warned were selling products that listed CBD as an inactive ingredient. The products were marketed as over-the-counter (OTC) pain relief products.

At the time of publication, the FDA had not granted marketing approval to any CBD product sold OTC.

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

CBD, derived from hemp or marijuana, has effects on people who take it and can pose health risks for some. The FDA said any product containing CBD — even as an inactive ingredient — cannot legally be marketed as an OTC drug.

The two companies the FDA issued warning letters to were Honest Globe Inc. and Biolyte Laboratories LLC. The FDA asked these companies for responses to the warning letters within 15 working days. In their responses, the companies have to describe how they will address the issues the FDA has pointed out.

Although CBD has gained popularity in some circles in recent years, the FDA has approved only one prescription CBD product. The FDA approved Epidiolex (cannabidiol) to treat seizures tied to certain conditions.

"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," Dr. Abernethy said. "Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”

Never take any new OTC or prescription product without first speaking with your health care provider.

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Review Date: 
March 29, 2021
Last Updated:
April 6, 2021