FDA Threatens Penalties, Refusal of Admission for 2 Foreign Cigarette Distributors
The Food and Drug Administration sent warning letters to two persons that offer cigarette products for sale to consumers in the U.S., alleging the products are adulterated. In a letter sent to Madeleine Rausis of Switzerland on Aug. 23 (here), FDA alleged the websites http://www.smoke-cigs.com and http://www.tobacco4you.com offer cigarettes for sale in the U.S. that are marketed as “light,” “mild,” or “low,” and so are adulterated “modified risk tobacco products.” The websites also offered cigarettes that FDA considers to be adulterated because they contain an artificial or natural flavor that is a characterizing flavor of the products. FDA also sent a warning letter to Andy Winata of Indonesia Aug. 20 (here), affiliated with the websites http://www.kretekindonesia.com, http://www.inacigarette.com, and http://www.inacigar.com, alleging the offering for sale in the U.S. of “modified tobacco risk products” and clove cigarettes, which FDA considers to be flavored.
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According to FDA, failure to ensure full compliance with the Food, Drug & Cosmetic Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products offered for importation into the U.S. are subject to detention and refusal of admission, it said.