The Vape-It Store – FDA Warning Letter, Oct 7, 2021

The FDA issued a Warning Letter to The Vape-It Store, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that The Vape-It Store manufactures and distributes e-liquid products for commercial distribution in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

Specifically, the product "Vapin by the Beach Green Orchard 12MG 60ML e-liquid" was found to be a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007. This product lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act.

The firm is a registered manufacturer with over 3,400 products listed with FDA. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement action. The letter requires a written response within 15 working days detailing actions to address violations, including discontinuation of violative sales and a plan for maintaining compliance