FDA WARNING_LETTER - Tiger Vapes - January 12, 2023

The FDA issued a Warning Letter to Tiger Vapes on January 12, 2023, following a review of submissions and inspection records. The FDA determined that Tiger Vapes manufactures and distributes e-liquid products, specifically "Grape Berries e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The FDA cited prohibited acts under section 301(k) for holding adulterated or misbranded products for sale after interstate shipment, and section 301(p) for failing to provide a required report under section 905(j). Tiger Vapes is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for future compliance