FDA WARNING_LETTER - W3 Markets LLC d/b/a ProSmoke - March 10, 2020

The FDA's Center for Tobacco Products reviewed prosmokestore.com and found that ProSmoke E-Cigarette Cartridges (Passion Fruit, Very Cherry, Awesome Apple) are manufactured and sold in the U.S. These ENDS products are deemed tobacco products under 21 U.S.C. § 321(rr) and subject to FDA regulation.

The FDA determined these are "new tobacco products" because they were not commercially marketed in the U.S. before February 15, 2007, and lack required premarket authorization under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are 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. Failure to provide a section 905(j) report is also a prohibited act under section 301(p).

ProSmoke must ensure all tobacco products and related advertising comply with the FD&C Act. Failure to correct violations may lead to civil money penalties, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation of violative sales and a compliance plan, is required within 15 working days. The reference number for the response is RW2001253.