FDA WARNING_LETTER - Alternavita - May 19, 2020

The FDA and FTC issued a Warning Letter to Alternavita.com after reviewing its website on May 8 and May 19, 2020. The firm, participating in the Amazon Associates program, promoted products like grapefruit seed extract, colostrum, and cod liver oil with claims implying they could mitigate, prevent, treat, diagnose, or cure COVID-19. These claims render the products unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502. The introduction of these products into interstate commerce is prohibited under sections 301(a) and (d), and any act leading to misbranding after interstate shipment is prohibited under section 301(k). The FTC also found it unlawful under 15 U.S.C. 41 et seq. to advertise disease treatment without competent scientific evidence, which is absent for these COVID-19 claims. Alternavita must immediately cease promoting these unapproved products. Within 48 hours, the firm must email both FDA (COVID-19-Task-Force-CDER@fda.hhs.gov) and FTC (rcleland@ftc.gov) detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply may result in legal action, including seizure, injunction, placement on FDA's public warning list, and potential consumer restitution for FTC violations.