FDA WARNING_LETTER - Escape Vape Lounge - August 17, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Escape Vape Lounge, identifying that the company manufactures and distributes e-liquid products, specifically "ESCAPE VAPE LOUNGE summers rain 60ml 12mg e-liquid product," which are deemed tobacco products under the FD&C Act.

The core violation is the marketing of a "new tobacco product" without the required premarket authorization. This e-liquid product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed 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 performing any act that results in an adulterated or misbranded tobacco product held for sale after interstate shipment is a prohibited act under section 301(k), and failure to provide a required report under section 905(j) is a prohibited act under section 301(p).

Escape Vape Lounge, a registered manufacturer with over 2,500 products listed with FDA, is responsible for ensuring compliance. Failure to address these violations may lead to regulatory actions, including civil money penalties, seizure, and/or injunction. The company