FDA WARNING_LETTER - Perfection Vapes, Inc. - January 15, 2021

The FDA issued a Warning Letter to Victor Canastraro of Perfection Vapes on January 15, 2021, following a review of their website, perfectionvapes.com. The FDA determined that e-liquid products offered for sale, specifically "Banana Nut Kringle" and "Krunchy Berry with Milk," are tobacco products under section 201(rr) of the FD&C Act and are 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 marketing 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, as required information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 41,500 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