# FDA WARNING_LETTER - www.indonesia-cigarettes.com - October 26, 2012

Source: https://www.keypedia.com/records/warning_letter/wwwindonesia-cigarettescom/1adef763-8c54-4785-ad94-3120a6e31d24

> FDA WARNING_LETTER for www.indonesia-cigarettes.com on October 26, 2012. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: www.indonesia-cigarettes.com
- Inspection Date: 2012-10-26
- Product Type: Tobacco
- Office Name: Department of Health and Human Services
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Indonesia Cigarettes and Clove Cigs on October 26, 2012, based on a review of their websites, indonesia-cigarettes.com and clovecigs.com. The FDA determined these websites are affiliated due to shared contact information and offer cigarette products for sale to U.S. customers.

The letter identifies several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Products are deemed adulterated under section 902(8) (21 U.S.C. § 387b(8)) because they are promoted as modified risk tobacco products without an FDA order. This includes products described as "mild," "light," or having "low tar low nicotine," such as Sampoerna Avolution Menthol, Sampoerna Flava, Marlboro Menthol, Djarum LA Lights, Star Mild, and U Mild. These descriptors and claims classify them as modified risk tobacco products under section 911(b)(2)(A)(i) and (ii) (21 U.S.C. § 387k(b)(2)(A)(i) and (ii)), requiring an FDA order under section 911(g) (21 U.S.C. § 387k(g)).

Additionally, numerous flavored cigarettes, including various Djarum, Gud

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- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/wwwindonesia-cigarettescom/318b2be8-2a3a-4968-af79-6a28ce5dd34e

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861