FDA WARNING_LETTER - Chavez, Inc. - September 25, 2009

The FDA issued a Warning Letter to Chavez, Inc. (aka CD2U, Cigarettes Direct 2 You, and Cigarettes Direct) after reviewing their websites in September 2009, which were offering Djarum Red Kretek Clove Cigarettes for sale to U.S. consumers. These products are classified as tobacco products under FFDCA section 201(rr). The FDA determined that the products are either adulterated or misbranded due to non-compliance with the Family Smoking Prevention and Tobacco Control Act (FSPTCA), specifically the "special rule for cigarettes" in section 907(a)(1)(A) of the FFDCA, which prohibits characterizing flavors (other than tobacco or menthol) in cigarettes after September 22, 2009. If the Djarum Red Kretek Clove Cigarettes contain clove as a characterizing flavor, they are adulterated under FFDCA section 902(5). Alternatively, if they do not contain a characterizing flavor, they are misbranded under FFDCA section 903(a)(1) because their labeling falsely represents the presence of clove as a characterizing flavor. Chavez, Inc. was instructed to immediately correct this violation by ceasing marketing and sale or taking other appropriate action to achieve compliance. A written response detailing their plan was required within 15 working days. Failure to comply could lead to regulatory actions such as seizure and injunction, and imported non-compliant products are subject to detention.