FDA WARNING_LETTER - Vape House - February 24, 2022

The FDA issued a Warning Letter to Vape House Inc. on February 24, 2022, following a review of submissions and inspection records. The FDA determined that Vape House Inc. manufactures and distributes e-liquid products, specifically identifying "Vape House Blueberry 30ml 3mg e-liquid product," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation is the marketing of a "new tobacco product" without the required premarket authorization. The identified e-liquid product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also cited as a prohibited act under section 301(p).

Vape House Inc. is a registered manufacturer with over 100 products listed with the FDA. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful 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 corrective actions, including discontinuation dates for violative sales and distribution, and a