FDA WARNING_LETTER - Euro-Cigs - October 08, 2009

On October 8, 2009, the FDA reviewed Euro-Cig's website, http://www.euro-cig.com, and found it was offering flavored cigarette products (Wismilak Slim Clove, Kiss Superslims Strawberry, Djarum Black Tea, and Sukon Orange 10) for sale to U.S. consumers. These products are considered tobacco products under FFDCA section 201(rr).

The FDA determined these products are adulterated and/or misbranded. Under FFDCA section 907(a)(1)(A), the "special rule for cigarettes" prohibits artificial or natural flavors (other than tobacco or menthol) that are characterizing flavors. Since the September 22, 2009, effective date, flavored cigarettes violating this rule are adulterated under FFDCA section 902(5). Euro-Cig's products are represented as containing clove, strawberry, tea, or orange as characterizing flavors. If true, they are adulterated for failing to comply with section 907(a)(1)(A). If they do not contain such flavors, they are misbranded under FFDCA section 903(a)(1) due to false and misleading labeling.

Euro-Cig must immediately cease marketing and selling these products to U.S. consumers or take other corrective action to comply with the FFDCA.