FDA WARNING_LETTER - Vapor Arts LLC d/b/a Main Street Vapor Co. - May 18, 2022

The FDA issued a Warning Letter to Vapor Arts LLC d/b/a Main Street Vapor Co. on May 18, 2022, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "Main Street Vapor Co. Fire breather e-liquid," which are classified as 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 "Fire breather e-liquid" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, a substantial equivalence order, or an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Prohibited acts include holding for sale an adulterated or misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

The FDA emphasized that all new tobacco products without premarket authorization are marketed unlawfully and are subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company, a registered manufacturer with over 60 listed products, must ensure all products comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including