FDA WARNING_LETTER - IndoCigs

The FDA's Center for Tobacco Products (CTP) issued a Warning Letter to Indocigs.com after reviewing their website and determining that cigarette products offered for sale to U.S. customers violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, Dunhill cigarettes in a light blue pack and Djarum L.A. cigarettes are deemed adulterated under section 902(8) of the FD&C Act because they are promoted as "modified risk tobacco products" (using descriptors like "Light" and "Mild") without an FDA order, violating section 911(a).

Additionally, all clove cigarettes advertised on the website are adulterated under section 902(5) or misbranded under section 903(a)(1). This is due to their purported characterizing flavors (clove, cherry, tea, cappuccino), which violate section 907(a)(1)(A) prohibiting artificial or natural flavors (other than tobacco or menthol) in cigarettes. If these products lack characterizing flavors, their labeling is considered false and misleading.

Indocigs.com must immediately correct these violations and ensure all tobacco products comply with the FD&C Act. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products are also subject to detention and