19/20 October 2021
The U.S. Food and Drug Administration (FDA) has recently issued warning letters to two companies for selling cannabidiol (CBD) products for pain relief. In particular, the warning letters address the illegal marketing and labelling of the over-the-counter (OTC) CBD products. The Agency has so far not approved any CBD-containing drug product other than one prescription drug (Epidiolex®).
The CBD containing products that are the subject of the two warning letters issued have not gone through the FDA drug approval process and are therefore considered unapproved new drugs. According to the Agency, "OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient".
The FDA warning letters further 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 (cGMP), like for example:
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases.