Shop Vapes Inc. – FDA Warning Letter, Nov 17, 2021

The FDA issued a Warning Letter to Shop Vapes, Inc. on November 17, 2021, following a review of submissions and inspection records. The FDA determined that Shop Vapes, Inc. manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act, requiring compliance with FDA regulations.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products SHOP VAPES CREAM CHEESE ICING 3%, SHOP VAPES ENERGY DRINK 12% 15ML, SHOP VAPES CRANBERRY 6% 15ML, and SHOP VAPES STRAWBERRY KIWI 3% 15ML were found to be 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.

Shop Vapes, Inc. is a registered manufacturer with over 900 products listed. Their Premarket Tobacco Product Application (PMTA), STN PM0001053, submitted on September 5, 2020, received