Ewin Soft and Trade SRL – FDA Warning Letter, Oct 8, 2009

On October 8, 2009, the FDA reviewed the website http://www.online-cigarettestobacco.com and found it was offering Wismilak Slim Clove, Kiss Superslims Strawberry, Djarum Black Tea, and Sukun Orange 10 (unfiltered) cigarettes for sale in the United States. These products are considered tobacco products under section 201(rr) of the FFDCA.

The FDA determined these products are adulterated and/or misbranded because they are represented as cigarettes containing artificial or natural characterizing flavors, which violates the "special rule for cigarettes" in section 907(a)(1)(A) of the FFDCA. This rule prohibits cigarettes from containing characterizing flavors other than tobacco or menthol, effective September 22, 2009. If the products do contain these flavors, they are adulterated under section 902(5) of the FFDCA. If they do not contain the flavors but are marketed as such, they are misbranded under section 903(a)(1) of the FFDCA due to false and misleading labeling.

The company must immediately cease marketing and selling these products or take other actions to achieve compliance. Failure to correct the violation may result in regulatory actions, including seizure and injunction. Adulterated or misbranded tobacco products offered for import into the U.S. are subject to detention