The U.S. Food and Drug Administration has issued a warning letter to Massachusetts-based Curaleaf for illegally selling CBD products with unapproved claims of therapeutic benefits.
The company stated that its products containing cannabidiol can treat ailments such as cancer, Alzheimer’s disease, opioid withdrawal, and pain and pet anxiety, among other conditions or diseases.
Acting FDA Commissioner Ned Sharpless, M.D. said in a statement, “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. 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.”
The FDA has requested responses from Curaleaf within 15 days regarding how it would remedy several violations, with failure to correct them potentially leading to legal action being taken, including product seizure and injunction.
FDA Principal Deputy Commissioner Amy Abernethy stated, “We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD.”