FDA WARNING_LETTER - Kloc Vapor, LLC d/b/a The Vapor Edge - November 09, 2021

The FDA issued a Warning Letter to Kloc Vapor, LLC d/b/a The Vapor Edge, on November 9, 2021, for manufacturing and distributing unapproved new tobacco products. The FDA determined that e-liquid products, specifically "The Vapor Edge Strawberry Breeze 6 MG 30 ML" and "The Vapor Edge Tropic Thunder 3 MG 30 ML," are tobacco products under the FD&C Act and require premarket authorization. These products were not commercially marketed before February 15, 2007, making them "new tobacco products" subject to FDA marketing authorization requirements.

The company's Premarket Tobacco Product Application (PMTA), STN PM0003604, submitted on September 9, 2020, received a Marketing Denial Order on September 8, 2021, covering 1,718 products. Consequently, the aforementioned e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required marketing authorization and failure to provide necessary information under section 905(j).

The FDA considers the marketing of these products without premarket authorization unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. The company must submit a written response within 15 working days detailing