FDA WARNING_LETTER - http://www.dirtcheapbutts.com

The FDA's Center for Tobacco Products reviewed the website dirtcheapbutts.com and found that its cigarette products are offered for sale in the United States, making them subject to FDA jurisdiction. The FDA determined that several cigarette products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without an FDA order. These products are described using terms like "light," "super light," "extra light," "ultra light," and "mild," or imply reduced risk (e.g., "a healthier cigarette choice").

Additionally, several cigarette products are adulterated under section 902(5) or misbranded under section 903(a)(1) or 903(a)(7)(A) of the FD&C Act because they purport to contain a natural or artificial characterizing flavor, which is prohibited for cigarettes as of September 22, 2009. Examples include "Aroma Rich Apple" and "Richmond Cherry."

The letter requires immediate corrective actions, including discontinuing the violative promotion, advertising, sale, and distribution of these products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.