FDA WARNING_LETTER - www.cigsbymail.com

The FDA's Center for Tobacco Products reviewed the website http://www.cigsbymail.com and found that "Agenda Slims Vanilla" cigarettes are promoted for sale in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act.

The "Agenda Slims Vanilla" cigarettes are deemed adulterated under section 902(5) of the FD&C Act because they are purported to contain a characterizing vanilla flavor, which is prohibited in cigarettes (other than tobacco or menthol) by section 907(a)(1)(A) of the FD&C Act as of September 22, 2009. If the product does not contain a characterizing flavor, it is misbranded under section 903(a)(1) or 903(a)(7)(A) of the FD&C Act due to false or misleading labeling/advertising.

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 offered for import are subject to detention. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within 15 working days.