Algisiya Servicesz Limited – FDA Warning Letter, Sep 29, 2009

On September 29, 2009, the FDA reviewed www.dutyfreedepot.com and found it offering Camel Orange/Mild Cigarettes for sale to U.S. consumers. These products are considered tobacco products under FFDCA section 201(rr). The FDA determined that Camel Orange/Mild Cigarettes contain an artificial or natural flavor, orange/mild, which is a characterizing flavor. This violates FFDCA section 907(a)(1)(A), the "special rule for cigarettes," which prohibits characterizing flavors (other than tobacco or menthol) in cigarettes.

Therefore, if the product contains this characterizing flavor, it is adulterated under FFDCA section 902(5). Alternatively, if it does not contain the flavor, it is misbranded under FFDCA section 903(a)(1) due to false and misleading labeling. The website described the product as "Camel Orange/Mild Cigarettes," labeled it "Camel ORANGE" with orange packaging, and offered it for sale to U.S. consumers.

The FDA requires immediate correction of this violation by ceasing marketing and sale, or taking other appropriate action to achieve compliance. Failure to comply may result in regulatory actions including seizure and injunction. For non-U.S. entities, adulterated or misbranded products are subject to detention and refusal of admission. A written response is required within 15 working days,