The Food and Drug Administration has sent warning letters to two companies for selling products with CBD in ways that violate the federal Food, Drug and Cosmetic Act. Honest Globe and Biolyte Labs received letters because CBD cannot be legally marketed as an inactive ingredient in OTC drug products that haven’t been reviewed and approved by the FDA, as well as substandard manufacturing practices.
"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 Dr. 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. 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 a risk to public health."
The FDA noted that the products covered by the warning letters had not gone through the FDA’s drug approval process and are considered unapproved new drugs. The agency also has not evaluated whether the products are effective for uses that manufacturers claim, what an appropriate dose might be, how they might interact with FDA-approved drugs or any potential side effects or safety concerns.
The agency requested written responses from the companies within 15 working days, addressing how they will address the violations or providing reasoning and supporting information as to why they believe the products don’t violate the law.