FDA Sends Warning Letter to Top CBD Company Over “Unsubstantiated” Health Claims

By Harris Wheless

The Food and Drug Administration announced Tuesday that it had issued a warning letter to Curaleaf, the world’s largest cannabis company, for selling CBD products with “unsubstantiated claims” that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety.

The agency said in the warning letter sent to the Massachusetts-based company that the products are unapproved drugs sold in violation of the Federal Food, Drug, and Cosmetic Act. It said Curaleaf made “unfounded claims about more than a dozen different CBD products” on its online store and social media websites.

The FDA has said it will take action against companies making “egregious” health claims. Curaleaf shares fell more than 7% in trading Tuesday after the announcement was made.

The agency said Curaleaf seems to be marketing its products as dietary supplements, although they don’t meet the definition established in the FD&C Act. The agency said the company’s pet products are unapproved animal drugs also in violation of the Act.

In the FDA’s new release, commissioner Ned Sharpless said Curaleaf’s claims might lead people to delay medical treatment of a serious condition. He also said “Consumers should beware of purchasing or using any such products.”

The FDA has yet to approve general CBD supplements for the treatment of any disease or condition, nor has it created a Recommended Daily Intake (RDI) for CBD users.

Since congress legalized hemp in December, the FDA has exercised some regulation over the new CBD market. Although it has sent roughly two dozen similar warning letters to smaller businesses, this is the first warning that has been issued to a CBD market leader.

In March, CVS began carrying Curaleaf’s line of CBD lotion and CBD transdermal patches. Following the FDA’s warning letter, the retailer announced it would be removing these items from its stores.

Other national retailers selling CBD in their stores include Walgreens, Rite Aid, and Kroger, among others. As of early July 2019, these are the retailers who stock CBD, the percent of stores where it’s being sold, and the kinds of products carried. CVS’s numbers are subject to change since the FDA’s warning letter.

Retailer Total US retail stores % of stores selling CBD Vape pens Topical Tinctures Oral pouches Capsules/ oils Pet products
CVS 9,800 8% yes
Walgreens 9,560 16% yes
Rite Aid 2,500 8%
Vitamin Shoppe 700 < 1% yes
GNC 6,200 < 1% yes
Sheetz 500 28% yes yes yes yes yes yes
Kroger 2,700 35% yes
Kwik Trip 1,000 < 1% yes yes yes yes yes
Bed, Bath, and Beyond 1,024 < 1% yes
Sephora 430 < 1% yes

The FDA’s letter, addressed to Curaleaf CEO Joseph Lusardi, was dated Monday and said the company had 15 days to notify the agency of steps it had taken to correct the violations. Failure to do this could result in legal action, such as product seizure or injunction, the agency said.

Curaleaf said it will work with the FDA to resolve the issues addressed in the warning letter. The company “is fully committed to complying with FDA requirements for all of the products that it markets,” Curaleaf said in a statement.

The company has already begun to take action in response to the FDA’s letter. On Friday morning, Curaleaf scrubbed its website and social media for CBD health claims.

The FDA has only approved one product comprised of an active ingredient in cannabis. Epidiolex, a CBD-based oral solution, was approved in June 2018 to treat two rare forms of childhood epilepsy.

This lack of approval has led to little regulation of the booming CBD industry. The agency plans to hold a public hearing in the fall to discuss its regulatory approach and produce a report on the matter.

“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 Sharpless.

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