FDA WARNING_LETTER - Rokok Zone - October 09, 2009

The FDA issued a Warning Letter to rokozone.com after reviewing its website on October 9, 2009, and finding 16 unfiltered, 34 filtered, and 23 mild clove cigarettes offered for sale to U.S. consumers. These products are classified as tobacco products under FFDCA section 201(rr). The primary violation stems from the representation that these cigarettes contain clove as a characterizing flavor. Under FFDCA section 907(a)(1)(A), a special rule for cigarettes prohibits artificial or natural flavors (other than tobacco or menthol) or herbs/spices, including clove, that are characterizing flavors, effective September 22, 2009. Consequently, if the products contain a characterizing clove flavor, they are adulterated under FFDCA section 902(5) for failing to comply with this rule. Alternatively, if they do not contain such a flavor, they are misbranded under FFDCA section 903(a)(1) due to false and misleading labeling. The FDA requires immediate correction by ceasing marketing and sale or taking other actions to achieve compliance. A written response detailing the plan for discontinuing sales or relabeling is required within 15 working days. Failure to comply may lead to regulatory actions such as seizure, injunction, and refusal of admission for imported products.