FDA WARNING_LETTER - SmokeTip.com, LLC - October 15, 2019

The FDA issued a Warning Letter to the operator of smoketip.com on September 30, 2019, following a review of their website. The FDA determined that the electronic nicotine delivery system (ENDS) and e-liquid products advertised and sold on smoketip.com are tobacco products under the FD&C Act.

The primary violation identified is that several ENDS and e-liquid products, including "Disposable Electronic Cigarette Menthol" and "Fresh Vaping E-Liquid – Fruity Pebbles," are misbranded. This misbranding occurs because their website advertising fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b).

Consequently, the products are misbranded under section 903(a)(7)(B) of the FD&C Act for violating regulations prescribed under section 906(d). Additionally, the products are misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because the absence of the required warning makes the labeling and/or advertising false or misleading by failing to reveal material facts about the product's consequences.

The FDA requires immediate corrective actions, including discontinuing the violative labeling, advertising, sale, and distribution of these products