FDA WARNING_LETTER - Prestige Worldwide Worldwide LLC d/b/a Vape 911 - August 18, 2022

The FDA issued a Warning Letter to Prestige Worldwide Worldwide LLC d/b/a Vape 911 on August 18, 2022, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "FAT KID e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order, a substantial equivalence order, or an exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information were not provided.

The letter states that the failure to provide required reports under section 905(j) is a prohibited act under section 301(p). The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.