FDA Issues Warning Letter to Curaleaf for Unsubstantiated Claims About CBD Products

The FDA has issued a warning letter to Curaleaf Inc., for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer disease, opioid withdrawal, pain, and pet anxiety.

According to the warning letter issued to the Massachusetts-based company, product messaging on Curaleaf’s webpages, its online store, and social media websites have made unfounded claims about more than a dozen different CBD products.

 The following statements are a sample of the messaging that the federal agency is disputing:

• “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
• “CBD was effective in killing human breast cancer cells.”
• “CBD has also been shown to be effective in treating Parkinson’s disease.”
• “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.” 

Curaleaf, Inc., who sells CBD products marketed to consumers as creams, oil drops, capsules, syrups, and teas, will have 15 days to formulate responses to the letter indicating how the violations will be corrected.

Other than Epidiolex (cannabidiol), approved to treat rare, severe forms of epilepsy in patients 2 years of age and older, the FDA has not approved any other CBD products. In December, Congress legalized CBD, which is a nonintoxicating cannabinoid found in cannabis and hemp.

“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 Ned Sharpless, MD, acting FDA commissioner in a prepared 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. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD.”

Founded in 2010, Curaleaf became the world's largest cannabis company by revenue and the largest in the United States following 2 acquisitions of Select and Grassroots brands, in May and June, respectively. After the deals, Curaleaf will have 68 open dispensaries, 20 cultivation sites and 26 processing facilities. Last year, the company reached $77.1 million in revenue.

Curaleaf, Inc. joins Advanced Spine and Pain LLC (Relievus), Nutra Pure LLC (CBDpure), and PotNetwork Holdings Inc. (DiamondCBD) in receiving warning letters from 2019 alone.

Consumers are asked to report any side effects from CBD-associated products with the FDA’s MedWatch program.

References

• FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety [press release]. FDA Published July 23, 2019. https://www.fda.gov/news-events/press-announcements/fda-warns-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-cancer. Accessed July 23, 2019. 

• Katie Kosko. FDA Issues Warning to Curaleaf for 'Illegally Selling' CBD Products Claiming to Treat Cancer. Cure Today website. Published July 23, 2019. https://www.curetoday.com/articles/fda-issues-warning-to-curaleaf-for-illegally-selling-cbd-products-claiming-to-treat-cancer. Accessed July 23, 2019.