FDA WARNING_LETTER - N3Vapor, LLC Kill Devil Hills - March 15, 2022

On February 25, 2022, the FDA issued a Warning Letter to Nikolaos Louvros of N3Vapor, LLC, following a review of their website, https://www.n3vapor.com. The FDA determined that e-liquid products, specifically "N3Vapor Blue Donutz" and "N3Vapor Cotton Candy," were being manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. The primary violation identified is that these 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 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.

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. N3Vapor, LLC is a registered manufacturer with over 11,20