FDA Issues Warning Letter to CBD Co. for Unsubstantiated Claims

The U.S. Food and Drug Administration (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’s disease, opioid withdrawal, pain and pet anxiety.” FDA cites the company’s website and social media accounts to assert that Curaleaf’s marketing establishes its products—including “Bido CBD for Pets”—as drugs or animal drugs because the products are portrayed as able to help alleviate anxiety and fear, among other purported benefits.

The agency also indicated that it will update the public on its progress towards creating a CBD regulatory framework by fall 2019. “We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products,” an FDA official stated in a press release. “We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD. The step-wise, science-based approach we’re taking protects patients and the public health, fosters innovation for safe and appropriate products, and promotes consumer confidence.”

Shook’s Cannabis Law Team released a white paper on the legal landscape for the global cannabis market suggesting that governmental entities may increase enforcement action against companies for unsubstantiated claims. Read more >>