FDA WARNING_LETTER - marcigs.com

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

The primary violation is the sale and distribution of "modified risk tobacco products" without an FDA order, as required by section 911(a) of the FD&C Act. This renders the products adulterated under section 902(8). The website uses descriptors like "light," "mild," or "low" for products such as Camel Mild, Camel Essential Blue, Marlboro Lights, Parliament Lights, and Winston Blue Super Slim. Additionally, products like Benson & Hedges Lights Gold King Box, Camel Mild, and L&M Blue/Lights are described as having "lower levels of Tar and Nicotine," "smart filter for maximum Tar protection," or "less quantities and taste of Nicotine and Tar," which also classify them as modified risk tobacco products under section 911(b)(2)(A)(i) and (ii).

The FDA 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 imported