FDA WARNING_LETTER - KratomNC - June 25, 2019

The FDA issued a Warning Letter to Kratom NC (Mike Davies) on May 16, 2019, following a May 2019 review of their website, kratomnc.com. The FDA determined that Kratom NC was marketing various kratom products, including "Green Bali Powder" and "Red Indo Powder," as unapproved new drugs and misbranded drugs. These products were promoted for uses such as treating opioid addiction, despite the ongoing national opioid public health emergency, and without FDA approval for safety and efficacy. Specifically, the products are considered unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a), 331(d)) because they are not generally recognized as safe and effective for their intended uses. Furthermore, they are misbranded under section 502 of the FD&C Act (21 U.S.C. 352), particularly under section 502(f)(1) (21 U.S.C. 352(f)(1)), for failing to bear adequate directions for use, as their intended conditions require professional supervision. The introduction of these misbranded drugs into interstate commerce also violates section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Kratom NC is required to take prompt action to correct these violations and notify the FDA in writing within fifteen working days, detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction.