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WARNING LETTER
•www.indonesiastore.net, www.clovecigarette.org

www.indonesiastore.net, www.clovecigarette.org – FDA Warning Letter

Record Details

The FDA issued a Warning Letter to Ms. Irmayani regarding tobacco products offered for sale to U.S. customers via http://www.indonesiastore.net, http://www.clovecigarette.org, and http://www.rokokkretek.com. The FDA determined these websites are affiliated.

The violations include: 1. **Modified Risk Tobacco Product Violations:** Products are promoted as "light," "mild," or with reduced tar/nicotine (e.g., Djarum Black Menthol Supersmooth, Gudang Garam Surya Slim, Dunhill Blue, Bentoel X Mild, Djarum LA Lights Menthol) without an FDA order under section 911(g) of the FD&C Act. This renders them adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). 2. **Flavored Cigarette Violations:** Numerous cigarettes (e.g., Bentoel Star Mild Menthol 16, Djarum Black Cappucino, Sampoerna Flava Click Mint, Gudang Garam Surya Slim Menthol) are offered with characterizing flavors (e.g., clove, cinnamon, spice, cappuccino, tea, fruit, mint, vanilla, cherry). This violates section 907(a)(1)(A) of the FD&C Act (2

Company
www.indonesiastore.net, www.clovecigarette.org
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · c2f6811b-d657-42fb-9e3b-5fa75183cf1f

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387b(8)21 U.S.C. 387b(5)21 U.S.C. 387c(a)(1)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 387k(b)(2)(A)(ii)21 U.S.C. 387k(b)(2)(A)(i)21 U.S.C. 387k(a)21 U.S.C. 387k(g)

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