FDA WARNING_LETTER - CloveCigarettesShop.com - October 13, 2009

The FDA issued a Warning Letter to clovecigarettesshop.com on October 13, 2009, after reviewing their website and identifying the sale of various filtered, mild filtered, and unfiltered clove cigarettes to U.S. consumers. These products, including brands like Djarum Black, Gudang Garam, and Sampoerna A Mild, are classified as tobacco products under section 201(rr) of the FFDCA.

The core violation stems from section 907(a)(1)(A) of the FFDCA, which prohibits cigarettes from containing artificial or natural flavors (other than tobacco or menthol) that are characterizing flavors. The FDA determined that the listed products are represented as cigarettes containing clove as a characterizing flavor. If these products indeed contain clove as a characterizing flavor, they are adulterated under section 902(5) of the FFDCA for failing to comply with the special rule for cigarettes. Alternatively, if they do not contain clove as a characterizing flavor, they are misbranded under section 903(a)(1) because their labeling falsely represents them as having a characterizing clove flavor.

The FDA demands immediate correction of this violation by ceasing the marketing and sale of these products or taking other appropriate action to achieve compliance. Failure to comply may result in regulatory actions such as seizure, injunction, and detention/refusal of admission for imported products. The company must submit a written