FDA WARNING_LETTER - Hamburger Cigarren Contor (HACICO) GmbH UG

The FDA issued a Warning Letter to Ms. Molter regarding tobacco products offered for sale to U.S. customers via http://www.hacico.de. The Center for Tobacco Products determined that several cigarette and smokeless tobacco products are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, five cigarette products (Djarum Super Filter, Djarum Special Filter, Djarum Black Filter, Djarum Cherry Filter, and Djarum Menthol Filter) are cited for purporting to contain characterizing flavors (clove, cherry), making them adulterated under section 902(5) of the FD&C Act. If these products do not contain characterizing flavors, they are misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling/advertising.

Additionally, eleven smokeless tobacco products (Alpenprise, Braniff, Edel-Prise, Kensington, Pöschl, Rumney’s, Singleton’s, Tucky, Grimm & Triepel, Tobacco Cuts, and Oliver Twist) are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because their webpages fail to include required health warning statements, as mandated by the Comprehensive Smokeless Tobacco Health Education Act of 1986. The