FDA WARNING_LETTER - American Vapor Inc. - July 11, 2025

This FDA Warning Letter, dated July 10, 2025, addresses American Vapor Inc., d/b/a Artisan Vapor Company, for selling and distributing unauthorized electronic nicotine delivery system (ENDS) products. The FDA determined that the company offers "Uno Mas X Apple Peach Strawberry 5% Nicotine," which is a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007.

Under sections 201(rr) and 901(b) of the FD&C Act, ENDS products are considered tobacco products subject to FDA jurisdiction. The letter highlights that as of March 15, 2022, the definition of "tobacco product" expanded to include products with nicotine from any source.

The identified product lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required notice under section 905(j).

The FDA requires prompt action to address these violations. The company must submit a written response within 15 working days, detailing actions taken to discontinue the sale/distribution of the violative product and a plan for maintaining compliance. Failure to comply may result in