FDA WARNING_LETTER - sunshine trading company, inc. - July 03, 2023

The FDA issued a Warning Letter to Joshua Miller of Novakratom.com on July 3, 2023, following a June 2023 review of their website. The FDA determined that Novakratom.com sells kratom products, including "Green Maeng Da Kratom Powder," "Red Bali Kratom Powder," and "White Borneo Kratom Powder," which are marketed for treating opioid addiction and withdrawal symptoms.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), because they are intended for disease treatment or to affect body function, as evidenced by claims on their website. The FDA states these products are not generally recognized as safe and effective (GRASE) for their intended uses and lack FDA approval. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

The FDA emphasizes that marketing unapproved opioid addiction treatments poses a significant public health threat, potentially causing patients to delay or forego approved treatments. The letter requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction