FDA WARNING_LETTER - Electric Smoke Vapor House - July 13, 2022

The FDA issued a Warning Letter to Electric Smoke Vapor House on July 13, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as of April 14, 2022.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, Electric Smoke Vapor House Churro, Cookie Dough, and Orange Creamsicle e-liquid products are cited as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also a prohibited act.

The company is a registered manufacturer with over 7,300 listed products. The FDA states that all new tobacco products on the market without premarket authorization are unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for maintaining compliance.