FDA WARNING_LETTER - www.topluckmall.com

The FDA's Center for Tobacco Products issued a Warning Letter to Topluckmall.com after reviewing their website and determining that Marlboro Gold cigarettes, also referred to as "Marlboro Light," were offered for sale to U.S. customers. These products are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that Marlboro Gold cigarettes are promoted as modified risk tobacco products without an FDA order, rendering them adulterated under section 902(8) of the FD&C Act. Specifically, the use of the descriptor "Light" in the product name and advertising classifies it as a modified risk tobacco product under section 911(b)(2)(A)(ii). Section 911(a) prohibits the introduction or delivery of such products into interstate commerce without an FDA order under section 911(g).

Topluckmall.com is required to immediately correct this violation and any similar ones, ensuring all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products are also subject to detention and refusal of admission into the U.S. A written response detailing corrective actions, including dates of discontinued violative activities and a plan for compliance, must be submitted within