FDA WARNING_LETTER - Boss Vapes - November 19, 2021

The FDA issued a Warning Letter to Boss Vapes LLC on November 19, 2021, following a review of submissions and inspection records. The FDA determined that Boss Vapes LLC manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the products BOSS VAPES BubbleMint 3mg 120ml, BOSS VAPES bcp 3mg 120ml, BOSS VAPES cotton candy 3mg 120ml, and BOSS VAPES cowboy saver 3mg 120ml 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 a prohibited act.

Boss Vapes LLC is a registered manufacturer with over 1,200 listed products. Their Premarket Tobacco Product Application (PMTA), STN PM0002949, submitted on September 2, 2020, received a Marketing Denial Order on September 9,