Chevaline Investments, LLC d/b/a VaporCore – FDA Warning Letter, Jan 12, 2023

The FDA issued a Warning Letter to Chevaline Investments, LLC d/b/a VaporCore for manufacturing and distributing "Brandy e-liquid products" without required marketing authorization. These e-liquid products are deemed tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The core violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information under section 905(j) were not provided.

The letter states that the manufacturing, selling, and/or distributing of these unauthorized products are prohibited acts under sections 301(k) and 301(p) of the FD&C Act. 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.

VaporCore must submit a written response within 15 working days detailing actions taken to address the violations, including dates