FDA WARNING_LETTER - dealcigarette.com

The FDA's Center for Tobacco Products reviewed the website http://www.dealcigarette.com and determined that the cigarette products offered for sale or distribution in the U.S. are tobacco products subject to FDA jurisdiction. The FDA found several cigarette products to be adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without an FDA order.

Specifically, the website sells or distributes Benson & Hedges Smooth Gold ("Benson & Hedges Lights") and Camel ("Camel Mild"), which use descriptors like "Lights" or "Mild." Additionally, Silk Cut and Silk Cut Silver are described as having "very low nicotine content." These products are considered modified risk tobacco products under sections 911(b)(2)(A)(ii) and 911(b)(2)(A)(i) of the FD&C Act due to these descriptors and claims of reduced substance levels.

Under section 911(a) of the FD&C Act, modified risk tobacco products cannot be introduced into interstate commerce without an FDA order. Since these products lack such an order, they are adulterated. The FDA requires immediate correction of these violations and similar issues, ensuring all tobacco products, labeling, and advertising 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. A written response