Warning Issued to CBD Maker Over ‘Illegal’ Claimsֺ

FDA has issued a Warning Letter to Curaleaf (Wakefield, MA) for 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. “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," acting FDA commissioner Ned Sharpless is quoted in a release as saying. “Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD.”

FDA is currently undergoing an internal review of CBD product regulation. It has established a high-level internal working group to explore potential pathways for various types of CBD products to be lawfully marketed. “An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform the agency’s consideration of potential regulatory frameworks for CBD while maintaining the FDA’s rigorous public health standards,” the agency says.

Regarding Curaleaf, FDA says the company used product Web pages, its online store and social media websites to make unfounded claims about more than a dozen different CBD products. Examples of the unsupported and unapproved claims made by the company include:

• “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 has been linked to the effective treatment of Alzheimer’s disease ….”
• “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
• “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.”

The Warning Letter requested responses from Curaleaf within 15 working days stating how the violations will be corrected.

FDA has previously sent Warning Letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer.