FDA WARNING_LETTER - Sabai Ventures Ltd - November 25, 2019

The FDA issued a Warning Letter to Sabaidee following a review of their website, www.getsabaidee.com, in October 2019, identifying several violations related to their cannabidiol (CBD) products. The agency determined that Sabaidee's "Good Vibes," "Super Good Vibes," and "Mega Good Vibes" products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. These human-use products are also misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for use, as they are intended for conditions not amenable to self-diagnosis and treatment. Additionally, the firm's "Pets Tincture" and "Chill Chews Soft Chews for Dogs" are deemed unapproved new animal drugs, unsafe under section 512(a), and adulterated under section 501(a)(5) of the FD&C Act. All CBD products are improperly marketed as dietary supplements, as CBD is excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. The FDA emphasizes that introducing or delivering these unapproved and misbranded products into interstate commerce violates the FD&C Act, requiring the firm to take prompt action to correct these significant compliance issues.