www.kretekstore.com – FDA Warning Letter, Mar 18, 2014

The FDA issued a Warning Letter to KretekStore.com on December 6, 2012, after reviewing their website and determining that their cigarette products were offered for sale to U.S. customers. The FDA found several products to be adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they were promoted as modified risk tobacco products without an FDA order. Specifically, products like Gudang Garam Surya Slim, Sampoerna Flava, Sampoerna Avolution, Djarum LA Lights Menthol, and Djarum LA Lights Mild 16 were described using terms like "mild," "low tar," or "low nicotine," which classify them as modified risk tobacco products under section 911(b)(2)(A) of the FD&C Act.

Additionally, numerous flavored cigarettes, including various "Bentoel," "Djarum," "Gudang Garam," "Sampoerna," "Wismilak," "Dunhill," "Lucky Strike," and "Marlboro" products, were found to be adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) for containing characterizing flavors other than tobacco or menthol, which is prohibited for cigarettes as of September 22