FDA WARNING_LETTER - SZ Vape LLC, d/b/a Vype Vapor - May 13, 2024

On May 13, 2024, the FDA issued a Warning Letter to SZ Vape LLC, d/b/a Vype Vapor, for selling and distributing unauthorized electronic nicotine delivery system (ENDS) products in the United States. The FDA determined that the company's ENDS products, including various EZEE Stick EZBar 5K and EZEE Stick 6K products, are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The letter emphasizes that the definition of "tobacco product" now includes products containing nicotine from any source, not just tobacco-derived nicotine.

SZ Vape LLC must submit a written response within 15 working days detailing actions taken to address the 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 penalties, seizure, and/or injunction.