FDA WARNING_LETTER - www.cigaretex.com

The FDA's Center for Tobacco Products reviewed cigaretex.com and found cigarette products offered for sale in the U.S. that violate the FD&C Act. Several products are deemed adulterated under section 902(8) because they are promoted as "modified risk tobacco products" (e.g., "light," "ultra light") without an FDA order, as required by section 911(a). Specific examples include "Bond Special Selection" (Lights) and "Bond Fine Selection" (Ultra Lights).

Additionally, products like "Aroma Rich Apple" and "Richmond Cherry" are adulterated under section 902(5) because they contain characterizing flavors other than tobacco or menthol, which is prohibited for cigarettes under section 907(a)(1)(A) since September 22, 2009. If these products do not contain characterizing flavors, they are misbranded under section 903(a)(1) or 903(a)(7)(A) due to false or misleading labeling/advertising.

The letter requires immediate correction of these violations and similar ones, ensuring all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products are subject to detention and refusal of admission into the U.