FDA WARNING_LETTER - IronVapin - October 08, 2019

On September 27, 2019, the FDA issued a Warning Letter to the operator of ironvapin.com for violations related to the sale and advertising of Electronic Nicotine Delivery System (ENDS) products. The FDA determined that ENDS products offered on the website are tobacco products under the FD&C Act.

The first violation cited was the sale of Bad Drip Labs Ugly Butter e-liquid to a person younger than 18 years of age, which is a violation of 21 C.F.R. § 1140.14(b) and renders the product misbranded under section 903(a)(7)(B) of the FD&C Act.

The second violation involved the misbranding of ENDS products due to the failure of website advertising to include the required nicotine warning statement as mandated by 21 C.F.R. § 1143.3(b). Examples cited include Dr. Frost Orange Mango ICE e-liquid, Junky’s Stash Buried Yesterday ICED e-liquid, and Mojo Disposable Pod Vape Device Case (30 Count) (Lemon Cake) ENDS. The advertisements failed to display the warning conspicuously, surrounded by a rectangular border, and occupying at least 20 percent of the advertisement area.

The letter requires immediate corrective actions for these and similar violations. Failure to comply may result in further FDA actions, including civil money penalties