Tampa Vapor Inc. – FDA Warning Letter, Nov 30, 2021

The FDA issued a Warning Letter to Tampa Vapor, Inc. on November 30, 2021, following a review of submissions and inspection records. The FDA determined that Tampa Vapor manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and require premarket authorization.

The core violation is the marketing of "new tobacco products" without the required FDA marketing authorization. Specifically, Tampa Vapor Apple 30ml 6mg, Tampa Vapor Strawberry 30ml 3mg, and Tampa Vapor Banana Nut Bread 30ml 6mg e-liquid products were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also cited as a prohibited act.

Tampa Vapor had submitted a Premarket Tobacco Product Application (PMTA), STN PM0001335, covering 1,762 products, which received a Marketing Denial Order on September 10, 2021. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.