FDA WARNING_LETTER - King Distribution LLC d/b/a Lava Vape USA

The FDA's Center for Tobacco Products issued a Warning Letter to Vape-USA.com on December 16, 2016, following a review of their website, which offers e-liquids for sale in the U.S. The FDA determined that these e-liquids are "tobacco products" under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of NicSelect Cola e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to minors. The NicSelect Cola e-liquid is classified as a "covered tobacco product" under 21 C.F.R. § 1140.3.

The letter mandates immediate correction of this violation and similar issues across all sales and advertising platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation dates of violative sales/advertising, and a plan for sustained compliance with the FD&C Act.