FDA WARNING_LETTER - Splash Ecig and Vapor Emporium - June 15, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Splash Ecig and Vapor Emporium on June 15, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically SPLASH VAPES AFFIRMED 6mg e-liquid, which are deemed tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The SPLASH VAPES AFFIRMED 6mg e-liquid was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

The letter states that the firm is a registered manufacturer with over 500 listed products. Marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

Splash Ecig and Vapor Emporium must submit a written response within 15 working days, detailing corrective actions, including discontinuation dates for violative sales/distribution, and a plan for maintaining compliance. Failure to address these violations may lead to