FDA WARNING_LETTER - MyKretek.com - October 07, 2009

On October 7, 2009, the FDA reviewed MyKretek.com and found it was offering various filtered, mild filtered, and unfiltered clove cigarettes (e.g., Djarum Black, Sampoerna A Mild, Dji Sam Soe Classic) for sale to U.S. consumers. These products are considered tobacco products under FFDCA section 201(rr).

The website represents these products as cigarettes containing clove as a characterizing flavor. This violates FFDCA section 907(a)(1)(A), the "special rule for cigarettes," which prohibits artificial or natural flavors (other than tobacco or menthol) that are characterizing flavors. Since the September 22, 2009, effective date, such flavored cigarettes are adulterated under FFDCA section 902(5). If the products do not contain a characterizing flavor, their labeling is false and misleading, making them misbranded under FFDCA section 903(a)(1).

MyKretek.com must immediately cease marketing and selling these products or take other actions to achieve compliance. Failure to correct this violation may result in FDA regulatory actions, including seizure and injunction. Adulterated or misbranded tobacco products imported into the U.S. are subject to detention and refusal. The FDA will inform officials in the company's operating country that these products are adulterated and/or misbranded and cannot be legally sold