Private I Salon, LLC – FDA Warning Letter, Nov 25, 2019

The FDA issued a Warning Letter to Privateirx CBD following a September-October 2019 review of their website and social media, citing numerous violations for products containing cannabidiol (CBD). Multiple human CBD products, including drops, cookies, gummies, sprays, and skincare items, are classified as unapproved new drugs (FD&C Act §§ 505(a), 301(d)) and misbranded drugs (§ 502(f)(1)) due to therapeutic claims and lack of adequate directions. Products marketed as dietary supplements, such as gummies and drops, fail to meet the definition under § 201(ff) because CBD is an active drug ingredient. The "CBD Cookie" is an adulterated human food (§ 402(a)(2)(C)(i)) containing an unsafe, unapproved food additive, making its interstate commerce a prohibited act (§ 301(ll)). Similarly, "Natural Flavor Pet Drops" and "CBD Pet Treats" are unapproved new animal drugs, unsafe (§ 512(a)), and adulterated (§ 501(a)(5)). Any CBD-containing animal food is also prohibited (§ 301(ll)) and adulterated (§ 402(a)(2)(C)(i)) as CBD is an unsafe animal food additive. The firm must respond within fifteen working days with corrective actions and prevention plans to avoid legal action, including seizure and injunction.