FDA WARNING_LETTER - BnB Enterprise LLC

On December 13, 2016, the FDA's Center for Tobacco Products issued a Warning Letter to elitensmoke.com after reviewing their website and determining they offered e-liquid and electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of misbranded tobacco products to a minor. Specifically, an underage person purchased DuraSmoke Watermelon Chill e-liquid and a FIN Disposable E-Cigarette Cool Menthol ENDS product from the website. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to individuals under 18 years of age. Consequently, these products are misbranded under section 903(a)(7)(B) of the FD&C Act.

The FDA requires immediate corrective actions, including discontinuing the violative sales and ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. 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 and a compliance plan is required within 15 working days.