FDA WARNING_LETTER - Stanley Brothers Social Enterprises, LLC

The FDA issued a Warning Letter to Stanley Brothers Social Enterprises, LLC (d/b/a CW Botanicals, d/b/a CW Hemp) following a review of their websites (www.cwbotanicals.com, www.cwhemp.com, www.theroc.us) and social media in August 2017. The agency determined that the company's CBD-containing products, including "Everyday Dietary Supplement" and "Charlotte's Web Gel Pen," are promoted with claims that establish them as unapproved new drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. These claims indicate intended use for disease diagnosis, cure, mitigation, treatment, or prevention. Furthermore, FDA concluded that CBD products are excluded from the dietary supplement definition per section 201(ff)(3)(B)(ii) of the Act. Since the products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) of the Act. Introducing such unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Additionally, the products are deemed misbranded under section 502(f)(1) of the Act because they lack adequate directions for use, as they are intended for conditions requiring supervision by a licensed practitioner. The introduction of these misbranded drugs violates section 301(a) of the Act. The company is required to take prompt corrective action and respond within fifteen working days, detailing steps taken to address the violations and prevent recurrence, or face potential legal action, including seizure and injunction.