FDA WARNING_LETTER - SIMPLYEJUICE, LLC d/b/a Simply E-Juice - April 30, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Steven Manley regarding e-liquid products sold on https://simplyejuice.net. The FDA determined that e-liquids, including "Simply Bodacious Blueberry" and "Simply Glorious Grape," are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization orders, as mandated by section 910(a) of the FD&C Act. A "new tobacco product" is defined as one not commercially marketed in the U.S. as of February 15, 2007, or a modified product marketed after that date. Since the identified e-liquids were not commercially marketed by February 15, 2007, and lack FDA marketing authorization, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 200 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to address these violations may result in regulatory actions such as civil money penalties