FDA WARNING_LETTER - Agripromo S.A. - January 18, 2013

On November 19, 2012, the FDA's Center for Tobacco Products issued a Warning Letter to Ipromo, based on a review of their website, http://www.enjoyably.com, which offered cigarette products for sale to U.S. customers.

The FDA determined that several of Ipromo's 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 (e.g., "Lights," "Ultra Lights") without an FDA order. Specific examples included "Marlboro Gold" (Lights) and "Marlboro Silver" (Ultra Lights).

Additionally, products like "Aroma Rich Apple" and "Richmond Cherry" were found to be adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) for containing characterizing flavors other than tobacco or menthol, which is prohibited for cigarettes as of September 22, 2009. If these products do not contain characterizing flavors, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) due to false and misleading labeling.

Ipromo was