Cigs365.com – FDA Warning Letter, Sep 28, 2012

The FDA's Center for Tobacco Products issued a Warning Letter to Cigs365.com after reviewing their website, http://www.cigs365.com, and determining that cigarette products were offered for sale to U.S. customers. The FDA found that several products were adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they were promoted as modified risk tobacco products without an FDA order.

Specifically, the website described products as "Lights" or "Ultra-Lights" in advertising and product names, which are considered descriptors for modified risk tobacco products under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Products listed with "Lights" descriptors included Bond Special Selection, Camel Blue, Marlboro Gold, and others. Products listed with "Ultra-Lights" descriptors included Bond Fine Selection, Camel Silver, Marlboro Silver, and others.

Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), modified risk tobacco products cannot be introduced into interstate commerce without an FDA order. Since Cigs365.com offered these products to U.S. customers without such