FDA WARNING_LETTER - www.indo-cigarettes.com

The FDA Center for Tobacco Products issued a Warning Letter to Indo-Cigarettes.com after reviewing their website and determining that their cigarette products are offered for sale in the United States. The FDA identified several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Firstly, several products are deemed "adulterated" under section 902(8) of the FD&C Act because they are promoted as "modified risk tobacco products" without an FDA order. This includes products labeled "light," "mild," or described as having "low tar low nicotine," such as "Marlboro Lights Menthol," "Gudang Garam Surya Slim," "Sampoerna Flava," "Djarum LA Lights Menthol," and "Bentoel Star Mild 16." These descriptors classify them as modified risk tobacco products under section 911(b)(2)(A) of the FD&C Act, requiring an FDA order for introduction into interstate commerce.

Secondly, numerous flavored cigarettes, including various "clove," "cappuccino," "tea," "fruity," and "mint" flavored products like "Bentoel Sejati," "Djarum Black Cappuccino," and "Sampoerna Flava," are considered "adulterated" under section 902(5) of the FD&C Act. This is due to violating section 907(a)(1)(A