FDA WARNING_LETTER - www.mangga-dua.com - June 15, 2012

On June 1, 2012, the FDA's Center for Tobacco Products issued a Warning Letter to www.mangga-dua.com after reviewing their website and determining that Djarum Black Cappuccino cigarettes were offered for sale to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The FDA found that the Djarum Black Cappuccino cigarettes are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) because they contain a characterizing flavor (cappuccino), which is prohibited in cigarettes by section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) as of September 22, 2009. Alternatively, if the cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) due to false and misleading labeling.

The letter requires immediate corrective actions to bring the tobacco products into compliance with the FD&C Act. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-