FDA WARNING_LETTER - Madeleine Rausis

The FDA's Center for Tobacco Products issued a Warning Letter to Ms. Rausis after reviewing her websites, http://www.smoke-cigs.com and http://www.tobacco4you.com, which offer cigarette products for sale in the United States. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act.

Several products are deemed adulterated under section 902(8) of the FD&C Act because they are promoted as modified risk tobacco products (e.g., "Lights," "Ultra Lights") without an FDA order, violating section 911(a). Specific examples include Bond Fine Selection, Camel Blue, Marlboro Gold, and Winston Blue, among many others listed under "Lights Cigarettes" or "Ultra Lights Cigarettes" categories.

Additionally, products like Aroma Rich Apple and Kiss Super Slims Fresh Apple 100s are adulterated under section 902(5) of the FD&C Act for containing characterizing flavors (other than tobacco or menthol), which is prohibited for cigarettes under section 907(a)(1)(A) as of September 22, 2009. If these products do not contain such flavors, they are misbranded under section 903(a)(1) due to false and misleading labeling.

Ms. Rausis is required to immediately correct these violations and