FDA WARNING_LETTER - H.J. Bailey Co. - October 31, 2009

The FDA issued a Warning Letter to H.J. Bailey Co. on October 5, 2009, following a review of their website, Hjbailey.com, which was offering Djarum Bali Hai 20S, Djarum Filter 20S, and Djarum Black 20S for sale to U.S. businesses. These products are classified as tobacco products under FFDCA section 201(rr).

The core violation concerns the "special rule for cigarettes" under FFDCA section 907(a)(1)(A), effective September 22, 2009, which prohibits cigarettes from containing artificial or natural flavors (other than tobacco or menthol) that are characterizing flavors. H.J. Bailey Co.'s website labeled the products as "clove cigarettes," indicating a characterizing clove flavor.

If these products contain a characterizing clove flavor, they are adulterated under FFDCA section 902(5) for failing to comply with the flavor ban. Alternatively, if they do not contain a characterizing flavor, they are misbranded under FFDCA section 903(a)(1) due to false and misleading labeling.

H.J. Bailey Co. was instructed to immediately correct this violation by ceasing marketing and sales or taking other appropriate action to achieve compliance. Failure to comply could result in regulatory actions such as seizure, injunction, or refusal