The US Food and Drug Administration (FDA) has sent a warning letter to Curaleaf Inc of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer's disease, opioid withdrawal, pain, and other conditions or diseases.
"Selling unapproved products with unsubstantiated therapeutic claims...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," Acting FDA Commissioner Ned Sharpless, MD, said in a statement.
The FDA "stands firm in its commitment to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for therapeutic uses for which they are not approved," said Sharpless.
In the warning letter, addressed to Curaleaf President Joseph Lusardi, the FDA says the company used product webpages, its online store, and social media to make unsupported and unapproved claims about more than a dozen different CBD products.
For example, the company claims that CBD has been shown to "have properties that counteract the growth of [and/or] spread of cancer." It also says that CBD is effective in killing human breast cancer cells and effective in treating Parkinson's disease and Alzheimer's disease and is "being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety."
The company also claims in marketing that CBD can "reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance." They further state that CBD oil is "becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety..., [and] ADHD."
Curaleaf has 15 business days to tell the FDA how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction. The company did not respond to a request for comment made by Medscape Medical News by press time.
The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure diseases, such as cancer.
The agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients, given the "potential opportunities and significant interest in drug and other consumer products containing CBD," FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in the release.
To date, the FDA has approved only one CBD product — a purified formulation of CBD (Epidiolex, GW Pharmaceuticals) — to treat two rare, severe forms of epilepsy (Lennox-Gastaut syndrome and Dravet syndrome).
No other CBD product is approved by FDA, and there is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects, the agency said.
The agency encourages healthcare professionals to report adverse reactions associated with these or similar products to the agency's MedWatch program.
Cite this: Megan Brooks. FDA Warns Curaleaf Over CBD Products With Unfounded Claims - Medscape - Jul 23, 2019.