Illegal Selling of CBD-Products: FDA Continues Issuing Warning letters

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5/6 June 2024

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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®).

CBD listed as inactive ingredient and failure to comply with cGMP

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:

• Releasing batches to the market without adequate QC testing.
• Production staff interchangeably performing manufacturing activities and quality approval of manufacturing steps and batch release.
• Records lacking adequate manufacturing details including: weights of charged components, mixing times, mixing speeds, measured temperatures, hold times, amounts removed for IPC testing, in-process observations and testing results, and filling machine settings.
• Missing equipment qualification and process validation.
• No stability data.

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.

For more information please read the FDA warning letters issued to Honest Globe Inc. and Biolyte Laboratories LLC.