www.vietnamtobacco.net – FDA Warning Letter, Sep 19, 2012

The FDA Center for Tobacco Products issued a Warning Letter to Tran Dang Phuc of Vietnam Tobacco on August 8, 2012, following a review of their website, http://www.vietnamtobacco.com. The review determined that cigarette products were offered for sale to U.S. customers.

The primary violation identified was the promotion of Marlboro Gold cigarettes as a "modified risk tobacco product" without an FDA order. Specifically, the website described the product as "VIETNAM MARLBORO LIGHT WHITE CIGARETTES CARTON," using the descriptor "light." Under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)), products using terms like "light," "mild," or "low" are considered modified risk tobacco products. Section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) prohibits the introduction or delivery of such products into interstate commerce without an FDA order. Consequently, the product was deemed adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).

The letter required immediate corrective actions to bring tobacco products into compliance. Failure to comply could result in civil money penalties,