FDA WARNING_LETTER - Andy Winata

The FDA's Center for Tobacco Products reviewed the websites http://www.kretekindonesia.com, http://www.inacigarette.com, and http://www.inacigar.com, determining that cigarette products offered for sale to U.S. customers are tobacco products under section 201(rr) of the FD&C Act. The websites are affiliated with Andy Winata.

Several products are adulterated under section 902(8) of the FD&C Act because they are promoted as modified risk tobacco products (MRTPs) without an FDA order, violating section 911(a). This includes products labeled "Light," "Mild," or similar descriptors, or claiming reduced substances (e.g., "low tar low nicotine"). Examples include "Marlboro Lights Menthol," "Djarum LA Light Mild," "Dunhill Lights," and products described as "mild clove cigarettes" or "lower in tar and nicotine."

Additionally, numerous flavored cigarettes, such as "Djarum Black Cappuccino," "Djarum Cherry," and various "clove cigarettes," are adulterated under section 902(5) of the FD&C Act, as section 907(a)(1)(A) prohibits characterizing flavors (other than tobacco or menthol) in cigarettes as of September 22, 2009. If these products lack characterizing flavors, they are misbranded