FDA WARNING_LETTER - Electrik Smoke LLC - August 02, 2022

The FDA issued a Warning Letter to Electrik Smoke LLC on August 1, 2022, following a review of submissions and inspection records. The FDA determined that Electrik Smoke LLC manufactures and distributes e-liquid products, specifically "Electrik Smoke PMS 12mg 30mL" and "Electrik Smoke Caramel Macchiato 3mg 30mL," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of these e-liquid products as "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information were not provided under section 905(j).

The FDA cited prohibited acts under section 301(k) for holding adulterated or misbranded products for sale after interstate shipment, and under section 301(p) for failing to provide required reports. Electrik Smoke LLC is required to submit a written response within 1