E-Cig Outlet LLC – FDA Warning Letter, Feb 26, 2021

The FDA issued a Warning Letter to Mark Mills of E-Cig Outlet on February 26, 2021, following a review of their website, https://e-cigoutlet.net. The FDA determined that e-liquid products offered for sale, specifically "E-Cig Outlet Boom Boom Pow" and "E-Cig Outlet Smurfberries," are tobacco products under section 201(rr) of the FD&C Act and subject to FDA regulation.

These e-liquid 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 lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 5,300 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must