FDA WARNING_LETTER - www.buytobacco.net - July 20, 2012

The FDA's Center for Tobacco Products reviewed buytobacco.net and found that cigarette products offered for sale to U.S. customers are adulterated. The website promotes products as "light" or "ultra-light" using terms like "Lights," "UltraLights," "Blue," and "Silver" in product names and advertising. Examples include "Marlboro Gold" and "Winston Subtle Silver."

Under section 911(b)(2)(A)(ii) of the FD&C Act, such descriptors classify these products as "modified risk tobacco products." Section 911(a) prohibits the introduction or delivery of modified risk tobacco products into interstate commerce without an FDA order. Since buytobacco.net offers these products without the required FDA order, they are deemed adulterated under section 902(8) of the FD&C Act.

The FDA requires immediate correction of these violations and compliance with the FD&C Act. Failure to comply may result in 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 promotion, advertising, sale, and/or distribution, is required within 15 working days. The reference number for this case is RW1200011