FDA WARNING_LETTER - Premiumestore, LLC - March 10, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Vitalijus Servutas after reviewing the website https://www.premiumecigarette.com, which offers Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. The FDA determined that these products, including Premium ecigarette Blueberry Cartomizers and Strawberry Vapor Pods, are "new tobacco products" under section 910(a) of the FD&C Act, as they were not commercially marketed before February 15, 2007. The firm is manufacturing and selling these products without the required premarket authorization order.

Consequently, these ENDS products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the necessary notices or information under section 905(j) were not provided. The failure to submit such reports also constitutes a prohibited act under section 301(p). The letter mandates that the firm ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including discontinuing violative activities and a compliance plan, is required within 15 working days. Non-compliance may result in civil money penalties, seizure, injunction, and refusal of admission for imported products.