The Vape Bar LLC d/b/a The Vape and More LLC – FDA Warning Letter, Dec 16, 2021

The FDA issued a Warning Letter to The Vape Bar LLC d/b/a The Vape and More LLC on December 16, 2021, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the manufacturing, sale, and/or distribution of the "RY4 Double 6mg 120ml e-liquid product" without the required premarket marketing authorization. This product is considered a "new tobacco product" because it 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 information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA noted the firm is a registered manufacturer with over 93,100 listed products. The letter emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit