FDA WARNING_LETTER - ECIGRUS LLC

The FDA's Center for Tobacco Products reviewed http://www.eliquid-usa.com and http://www.unovapor.com, determining that e-liquids and electronic nicotine delivery systems (ENDS) offered for sale are tobacco products under the FD&C Act. The FDA found that several e-liquid and ENDS products were misbranded under section 903(a)(7)(B) of the FD&C Act because they were sold to a person younger than 18 years of age.

Specifically, an underage person purchased Uno Vapor Lemonade e-liquid, a Disposable e-Cigar 1000 Puffs (menthol) ENDS, and Uno Vapor Apricot e-liquid from the websites. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquid and ENDS, to individuals under 18. These products are defined as "covered tobacco products" under 21 C.F.R. § 1140.3.

The FDA requires immediate correction of these violations and similar issues to ensure compliance with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales and a plan for maintaining compliance