FDA WARNING_LETTER - www.cigarettecart.com

The FDA Center for Tobacco Products reviewed the website http://www.cigarettecart.com and determined that cigarette products offered for sale to U.S. customers are adulterated. The products are considered tobacco products under section 201(rr) of the FD&C Act.

The violation stems from the sale and distribution of "modified risk tobacco products" without an FDA order, as required by section 911(a) of the FD&C Act. Specifically, products like Dunhill Fine Cut ("Dunhill Fine Cut Ultra Light"), Dunhill Blue ("Dunhill Light Blue"), Davidoff Gold ("Davidoff Light"), and Pine Lights ("Low Tar & Nicotine") are described using terms such as "light," "ultra light," or "low tar & nicotine" in their labeling or advertising. These descriptors classify them as modified risk tobacco products under section 911(b)(2)(A)(ii) and (i) of the FD&C Act, as they implicitly or explicitly represent reduced risk, reduced substance levels, or absence of a substance.

Because these products are sold without an FDA order under section 911(g), they are deemed adulterated under section 902(8) of the FD&C Act. The letter requires immediate corrective actions, including discontinuing violative promotion, advertising, sale, and distribution. A written response detailing corrective actions and a plan for compliance is required within 15 working days