FDA WARNING_LETTER - AZ Swagg Sauce LLC - July 13, 2022

On July 13, 2022, the FDA issued a Warning Letter to Bashar I. Dababneh, operating Swagg Sauce, following a review of their website, swaggsauce.com. The FDA determined that e-liquid products offered for sale, including "Blue Samurai Vape Juice," "Butter Cracker Vape Juice," and "Berry Cheesecake Vape Juice," are tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded jurisdiction to products containing nicotine from any source.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 2,600 listed products. The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or