FDA Issues Warning Letter To Curaleaf

The Food and Drug Administration (FDA) has issued a warning letter to Massachusetts-based cannabis company Curaleaf for marketing unapproved cannabidiol (CBD) products online with unsubstantiated claims that the products treat a variety of conditions including cancer, Alzheimer’s disease, pet anxiety, and opioid withdrawal.

Since 2015, The FDA has sent warning letters to around two dozen companies for selling CBD products that claim to prevent, diagnose, treat, or cure serious diseases.

In their letter to Curaleaf, the FDA lists more than a dozen of the company’s CBD products, including tinctures, vape pens, oils, patches, and pet products, that are available for sale on the their website and make unapproved claims about health or medical benefits.

“As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority,” said FDA Commissioner Ned Sharpless in a statement. “Selling unapproved products with unsubstantiated therapeutic claims—such as claims that CBD products can treat serious diseases and conditions—can put patients and consumers at risk by leading them to put off important medical care.”

The FDA has given Curaleaf 15 days to respond with how they intend to correct the violations or face legal action, which could include product seizure and injunction.

Curaleaf’s legal counsel is currently reviewing the letter, and the company does intend to respond within the time given, reports CNBC.

The FDA has a high-level internal working group that is currently exploring potential pathways for various CBD products to be lawfully marketed.

FDA Principal Deputy Commissioner Amy Abernethy says that the group plans to report on their progress in the fall.