FDA WARNING_LETTER - www.kretekstore.com - December 06, 2012

The FDA Center for Tobacco Products issued a Warning Letter to L. Panditya Sukmanjaya of www.kretekstore.com on December 6, 2012, following a review of their website. The FDA determined that several cigarette products offered for sale to U.S. customers were in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violations include: 1. **Adulterated Modified Risk Tobacco Products:** Products like Gudang Garam Surya Slim Menthol, Sampoerna Flava, and Djarum LA Lights were promoted with descriptors such as "mild" or "low tar low nicotine," classifying them as "modified risk tobacco products" under section 911(b)(2)(A) of the FD&C Act. These products were offered without an FDA order permitting such promotion, rendering them adulterated under section 902(8) of the FD&C Act. 2. **Adulterated Flavored Cigarettes:** Numerous products, including Djarum Black Cappuccino and Sampoerna A Mild Menthol, were identified as flavored cigarettes containing artificial or natural flavors (other than tobacco or menthol) that are characterizing flavors. This violates section 907(a)(1)(A) of the FD&C Act, making them adulterated under section 902(5). 3. **Misbranded Products:** If the flavored cigarettes