SpiceTac – FDA Warning Letter, May 18, 2020

On May 19, 2020, the FDA and FTC issued a Warning Letter to Spicetac.com regarding unapproved and misbranded products related to COVID-19. The FDA observed that Spicetac.com, as an Amazon Associate, promoted a vitamin C product with claims implying it could mitigate, prevent, treat, diagnose, or cure COVID-19. This renders the product an unapproved new drug under section 505(a) and a misbranded drug under section 502 of the FD&C Act.

The letter states that introducing or delivering this product into interstate commerce is prohibited under sections 301(a) and (d), and misbranding while held for sale after interstate shipment is prohibited under section 301(k). Given the public health emergency declared for COVID-19, the FDA is taking urgent measures against such products.

Spicetac.com was ordered to immediately cease promoting and participating in the sale of this unapproved and unauthorized product for COVID-19 related uses. Within 48 hours, Spicetac.com must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of firms receiving COVID-19 related