FDA WARNING_LETTER - Wick ‘N’ Vape, LLC - May 26, 2022

The FDA issued a Warning Letter to Wick ‘N’ Vape, LLC on May 26, 2022, following a review of submissions and inspection records. The FDA determined that Wick ‘N’ Vape manufactures and distributes electronic nicotine delivery system (ENDS) products, specifically "Cotton Bacon Prime 10g ENDS Cotton Wick" and "Cotton Bacon Version 2 10g ENDS Cotton Wick," which are considered tobacco products under the FD&C Act.

The core violation is that these ENDS products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required premarket authorization or notice (e.g., substantial equivalence report) was not provided.

The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a) and 301(p) of the FD&C Act. The FDA requires Wick ‘N’ Vape to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply