FDA WARNING_LETTER - Djarum America International Co., Ltd.

The FDA's Center for Tobacco Products issued a Warning Letter to Djarum America after reviewing their website, djarumamerica.com, and finding cigarette products offered for sale or distribution in the U.S. These products, including Djarum 76, Djarum Black, and others, are considered tobacco products under section 201(rr) of the FD&C Act. The FDA determined that these products purport to contain natural or artificial characterizing flavors, such as clove, cappuccino, or fruit. This violates section 907(a)(1)(A) of the FD&C Act, which prohibits such flavors (other than tobacco or menthol) in cigarettes. Consequently, the flavored cigarette products are deemed adulterated under section 902(5) of the FD&C Act. Alternatively, if these products do not actually contain a characterizing flavor, they are misbranded under section 903(a)(1) or 903(a)(7)(A) due to false or misleading labeling and advertising. The company must immediately correct these violations, discontinue all violative labeling, advertising, sale, and distribution, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may lead to further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction, and imported products may be detained or refused admission.