FDA WARNING_LETTER - Empire Imports, LLC d/b/a Vapor Empire, LLC - May 31, 2023

On May 31, 2023, the FDA issued a Warning Letter to Jason Angel regarding products sold on vaporempire.com. The Center for Tobacco Products determined that electronic nicotine delivery system (ENDS) products, specifically "Puff Plus TFN Disposable 800 Puffs 3.5mL – Guava Ice" and "Puff Plus TFN Disposable 800 Puffs 3.5mL – Lemon Ice," were offered for sale or distribution in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The FDA found these "Puff" ENDS products to be "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order 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 due to the absence of required notice or information under section 905(j).

The letter mandates a written response within 15 working days detailing actions to address violations,