FDA WARNING_LETTER - AZ Swagg Sauce LLC - June 16, 2020

On May 28, 2020, the FDA issued a Warning Letter to Bashar Dababneh regarding the sale and distribution of Electronic Nicotine Delivery System (ENDS) products on the website https://swaggsauce.com. The FDA determined that products like "Apple Pod For Glas," "Mylé Vape Replacement Pods - Lush Ice (Watermelon)," and "Naked100 Replacement Pods - Amazing Mango" are tobacco products subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These ENDS products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products are being offered for sale without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the necessary notice or information under section 905(j) was not provided.

The Warning Letter mandates that the recipient promptly correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, seizure, and/or