FDA WARNING_LETTER - ECIGRUSA LLC, d/b/a Worldwide Vape Distribution - May 16, 2025

On May 15, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to ECIGRUSA LLC, d/b/a Worldwide Vape Distribution, for selling and distributing unauthorized electronic nicotine delivery system (ENDS) products. The FDA determined that the company offers for sale the "FRIOBAR DB7000 Peach Ice 50mg/mL 16mL (5 PCS)" ENDS product, which is considered a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

This product lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The letter emphasizes that ENDS products, including those containing nicotine from any source, are subject to FDA jurisdiction and must comply with the FD&C Act and its implementing regulations.

ECIGRUSA LLC must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of the violative products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money