Gothic Vapor LLC – FDA Warning Letter, Oct 7, 2021

The FDA issued a Warning Letter to Gothic Vapor, LLC, following a review of their website, gothicvapor.com, which revealed the manufacture and sale of e-liquid products in the U.S. These products, including "Gothic Vapor – Tantra 30mL" and "Gothic Vapor – Coffee Break 50mL," are deemed "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. Consequently, they are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although the firm is a registered manufacturer with over 367,800 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0003720 received a Refuse to File determination on August 11, 2021 (covering 14,733 products) and a Marketing Denial Order on August 31, 2021 (covering