FDA WARNING_LETTER - Klarity Kratom - May 31, 2022

The FDA and FTC issued a Warning Letter to Klarity Kratom on June 30, 2022, following website reviews in May and June 2022. The letter states that Klarity Kratom sells numerous kratom products with claims establishing them as unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. The products are marketed for treating opioid addiction and withdrawal symptoms, despite not being determined safe or effective by the FDA. This poses a public health threat by potentially delaying FDA-approved treatments.

The FDA classifies these kratom products as "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective for their intended uses. Introducing these unapproved new drugs into interstate commerce without prior FDA approval is illegal.

The FTC also cited violations of the FTC Act, stating that advertising products to prevent, treat, or cure human disease, including addiction, requires competent and reliable scientific evidence, which is lacking for kratom. The FTC demands an immediate cessation of such claims. Violations of the FTC Act can result in injunctions and civil penalties up to $46,517 per violation under the Opioid Addiction Recovery Fraud Prevention Act of 2018.

Klarity Kratom must notify the FDA and FTC within fifteen working days of receipt of the letter, detailing specific corrective actions