FDA Sends Warning to Curaleaf for CBD Claims

The U.S. Food and Drug Administration sent a warning letter to the company for claiming CBD-based products could treat a range of serious diseases, including Alzheimer’s disease.

Curaleaf is “illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases,” the FDA wrote.

The FDA has asked for a response from the company within 15 working days, saying how it plans to address the violations. “Failure to correct the violations promptly may result in legal action, including product seizure and injunction,” said the letter.

The move is the first against a multi-state operator and is expected to shake the entire sector. CBD, a non-intoxicating ingredient in cannabis, is widely held to have wellness benefits and many companies are waiting for the FDA to create rules before launching product lines. But the FDA views CBD as a drug, because it’s the main ingredient in the only cannabis-based drug it has approved—GW Pharma’s Epidiolex, a treatment for severe childhood epilepsy.

The FDA has told companies that they cannot add CBD to food or beverages, although it appears willing to tolerate it in topical products—as long as companies don’t make serious health claims.

A Curaleaf spokesperson said the letter is currently under view by its legal counsel. The company intends to cooperate with the FDA and intends to remain compliant with all rules.

“We can reaffirm that nothing in the letter raises any issues concerning the safety of any Curaleaf product,” said the spokesperson. “Curaleaf products are all derived from hemp and meet the requirements of the Farm bill.”

Andrew Kessner, analyst at William O’Neil & Co., said it was not surprising that the first major action was against Curaleaf.

“Among MSOs, Curaleaf has made the largest push into CBD – with a full “Curaleaf Hemp” line. And the CVS partnership brought them a lot of attention, he said, referring to the partnership announced in March to sell a line of CBD products at the drugstore chain.

“So they’re a good company to make an example of - you can bet that any other MSO with similar content/claims on their website has already taken it down, or will have it down by the end of the day. Same goes for other public and larger private companies selling CBD products,” he said.