FDA WARNING_LETTER - Curaleaf, Inc - July 23, 2019

The FDA issued a Warning Letter to Curaleaf, Inc. following a review of their website and social media in April and June 2019, identifying multiple violations related to their cannabidiol (CBD) products. The agency determined that Curaleaf's “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, marketed with therapeutic claims for various human diseases. These products are also misbranded under section 502(f)(1) for lacking adequate directions for use, as the conditions are not amenable to self-diagnosis. Furthermore, Curaleaf's CBD products cannot be legally marketed as dietary supplements. CBD is excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act because it is an active ingredient in an FDA-approved drug or subject to substantial clinical investigations. Additionally, products like the CBD Lotion, Pain-Relief Patch, Vape Pen, and Tincture (when used topically) are not intended for ingestion, a requirement for dietary supplements under section 201(ff)(2)(A)(i). The letter also cited “Bido CBD for Pets” products as unapproved new animal drugs under section 201(v) of the FD&C Act, marketed with claims to mitigate or treat animal diseases. Lacking FDA approval or index listing, these animal products are considered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. Curaleaf must take prompt corrective action and notify the FDA within fifteen working days, detailing steps taken to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction.