FDA WARNING_LETTER - www.storecigarettes.com - July 09, 2012

The FDA Center for Tobacco Products issued a Warning Letter to storecigarettes.com on July 9, 2012, after reviewing their website and determining that certain cigarette products offered for sale to U.S. customers were adulterated or misbranded.

The inspection context revealed that products like Djarum “La” Light Menthol, Djarum Black Cappuccino, and Gudang Garam Surya were advertised with characterizing flavors such as cloves, cappuccino, tea, or fruit. This violates Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)), which prohibits cigarettes from containing artificial or natural flavors (other than tobacco or menthol) that are a characterizing flavor.

Consequently, these flavored cigarettes are deemed adulterated under Section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Alternatively, if these products do not contain a characterizing flavor, their labeling is considered false and misleading, rendering them misbranded under Section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)).

The FDA requires immediate corrective actions to bring all tobacco products into compliance. Failure to comply may result in further actions, including civil money penalties, no-tob