FDA WARNING_LETTER - Durango Smoke Shop, Inc. - January 12, 2010

On October 5, 2009, the FDA reviewed the website durangosmokeshop.com and found that Durango Smoke Shop, Inc. was offering for sale Nat Sherman Touch of Clove, Nat Sherman Hint of Mint, Nat Sherman Mint, Djarum Blacks Clove Cigarettes, Djarum Light Clove Cigarettes, Djarum Super Clove Cigarettes, and Djarum Special Clove Cigarettes. These products are considered tobacco products under section 201(rr) of the FFDCA.

The FDA determined that these products are either adulterated or misbranded. Under section 907(a)(1)(A) of the FFDCA, cigarettes cannot contain artificial or natural flavors (other than tobacco or menthol), herbs, or spices that are characterizing flavors. Since the products are represented as cigarettes containing mint or clove as a characterizing flavor, they are adulterated under section 902(5) of the FFDCA. If they do not contain such flavors, they are misbranded under section 903(a)(1) of the FFDCA because their labeling is false and misleading.

Durango Smoke Shop, Inc. was instructed to immediately correct this violation by ceasing the marketing and sale of these products or taking other appropriate action to achieve compliance. Failure to comply could result in regulatory actions such as seizure and injunction. A written response was required within 15 working days,