Apollo Future Technology Inc. d/b/a Apollo E Cigs – FDA Warning Letter, Mar 10, 2020

The FDA Center for Tobacco Products reviewed apolloecigs.com and found that Electronic Nicotine Delivery System (ENDS) products, specifically BREZ Deluxe Pod Kit (containing Berry Blend and Melon Pods) and BREZ Pods 4-Pack Melon, are manufactured and sold in the U.S. These products are deemed "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed before February 15, 2007.

The identified ENDS products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6). The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The company must ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to correct these violations may lead to civil money penalties, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation of violative sales and a compliance plan, is required within 15 working days.