FDA WARNING_LETTER - Vapor Galleria - June 28, 2022

The FDA issued a Warning Letter to Gary McBurney of VG Vapor on June 17, 2022, after reviewing their website, vgvapor.com. The FDA determined that VG Vapor manufactures and sells e-liquid products, which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product," specifically "Cotton Candy 60mL" e-liquid, without the required premarket authorization order. This 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 absence of required information under section 905(j).

The letter emphasizes that all new tobacco products without statutory premarket authorization are unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and injunction. VG Vapor is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products, and outlining a plan for future compliance.