FDA WARNING_LETTER - Kratom Exchange - June 30, 2022

The FDA and FTC issued a Warning Letter to Kratom Exchange after reviewing their website and social media in May and June 2022. The firm sells kratom products, such as “Red Maeng Da Kratom Powder,” with claims establishing them as unapproved new drugs. These products are marketed for treating opioid addiction and withdrawal symptoms, making them drugs under section 201(g)(1) of the FD&C Act, intended to diagnose, cure, mitigate, treat, or prevent disease. As they are not generally recognized as safe and effective for these uses, they are “new drugs” under section 201(p) and require prior FDA approval, which they lack, violating sections 505(a) and 301(d). Furthermore, the firm violates the FTC Act (15 U.S.C. §§ 41–57) by advertising that products can prevent, treat, or cure human disease, including addiction, without competent and reliable scientific evidence. The FDA emphasizes the public health threat posed by unproven opioid addiction treatments. Kratom Exchange must notify FDA within 15 working days of corrective actions and documentation. They must immediately cease all unsubstantiated health claims and notify the FTC within 15 working days of actions taken. Non-compliance could lead to legal action, including seizure, injunction, civil penalties up to $46,517 per violation, and consumer refunds.