USA Vapor Trails – FDA Warning Letter, Jul 19, 2022

On July 14, 2022, the FDA issued a Warning Letter to USA Vapor Trails, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that USA Vapor Trails manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation cited is the marketing of a "new tobacco product" without the required premarket authorization. Specifically, the product "Blue Strazzberry 6mg 60ml e-liquid" was found to be a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

USA Vapor Trails is a registered manufacturer with over 300 products listed with the FDA. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address the violations