TABlites Limited – FDA Warning Letter, Sep 27, 2019

The FDA issued a Warning Letter to Anthony Lee Greenfield and Jonathan Steven Greenfield, operating tablites.com, after reviewing their website and determining that their e-liquid products are tobacco products subject to FDA jurisdiction. The letter identifies three distinct violations, all leading to misbranding under section 903(a)(7)(B) of the FD&C Act. Firstly, the firm sold TABnic 10ml nicotine booster e-liquid to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). Secondly, the package for the TABnic 10ml nicotine booster e-liquid product failed to include the required nicotine warning statement, a violation of 21 C.F.R. § 1143.3(a). Lastly, the website's labeling and/or advertising for several e-liquid products, including Nasty Salt and Vampire Vape-Vamp Toes, did not include the mandatory nicotine warning statement, contravening 21 C.F.R. § 1143.3(b). The FDA mandates immediate correction of these and similar violations, requiring a written response within 15 working days detailing corrective actions, discontinuation dates, and a compliance plan. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction, and import refusal.