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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.indonesia-cigarettes.com 10/26/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229

OCT 26, 2012

VIA Electronic Mail
 
Indonesia Cigarettes
order@indonesia-cigarettes.com
 
Clove Cigs
order@clovecigs.com
 
 
 
WARNING LETTER
 
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed the websites, http://www.indonesia-cigarettes.com and http://www.clovecigs.com, and determined that your cigarette products listed there are offered for sale to U.S. customers. FDA believes these two websites are affiliated with one another because each website lists the same address and telephone number on its “Contact Us” webpage. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
                                                                                                                                    
FDA has determined that several of your products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that several of your products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
You describe products that you offer for sale to U.S. customers on the websites, http://www.indonesia-cigarettes.com and http://www.clovecigs.com as being mild and light by referring to them as such in product advertising and adding the qualifiers “Mild” and “Lights” to the product names and descriptions. For example, our review of your website http://www.indonesia-cigarettes.com revealed that you offer for sale the following cigarettes: Sampoerna Avolution Menthol and Sampoerna Avolution cigarettes described as “…the new mild generation” and Sampoerna Flava cigarettes described as “The First Mild Cigarettes…” In addition, our review of your website http://www.clovecigs.com revealed that you offer for sale the following cigarettes: Marlboro Menthol cigarettes described as “Marlboro Lights Menthol” and Sampoerna Avolution and Sampoerna Avolution Menthol cigarettes described as “…the new mild generation.” 
 
Furthermore, several tobacco products you offer for sale on your websites, http://www.indonsia-cigarettes.com and http://www.clovecigs.com are described as containing reduced levels of substances. For example, you describe on the website http://www.indonesia-cigarettes.com Djarum LA Lights Menthol and Djarum LA Lights Mild 16 cigarettes as “low tar low nicotine”; Star Mild 16 cigarettes as “…premium Low Tar Low Nicotine clove cigarette”; and U Mild 16 Clove cigarettes as “…the perfect blend of low tar and low nicotine cigarettes.” You describe on the website http://www.clovecigs.com Bentoel Star Mild 16 and Star Mild Menthol 16 cigarettes as “…premium Low Tar Low Nicotine clove cigarettes”; Djarum L.A. Lights Menthol and L.A. Lights Mild cigarettes as “…a low tar low nicotine…cigarette”; and U Mild cigarettes as “…the perfect blend of low tar and low nicotine…”
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents such product as containing a reduced level of a substance, presenting a reduced exposure to a substance, or being less harmful than one or more other commercially marketed tobacco products. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because your websites use the descriptors “Mild” and “Light” or similar descriptors for the above-listed products, and include claims that products contain a reduced level of a substance, present a reduced exposure to a substance, or are less harmful than other commercially marketed tobacco products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
 
Additionally, our review of your websites revealed that you offer for sale to U.S. customers on http://www.indonesia-cigarettes.com the following cigarettes, which are sold at your “Indonesia Clove Cigarettes Online Store”: Bingtang Buana cigarettes; Class Mild 16; Djarum 76; Djarum Black; Djarum Black Mild; Djarum Black Slimz; Djarum Black Tea; Djarum Black Cappuccino; Djarum Brown; Djarum Cherry; Djarum Special; Djarum Super 12; Djarum Super 16; Djarum Black Series; Djarum Series I; Djarum Series II; Dunhill Fine Cut Mild; Gudang Garam cigarettes; Neo Mild 16; Sampoerna A Mild 12; Sampoerna A Mild 16; Sampoerna A Mild Menthol 16; Star Mild 16; and U Mild 16. In addition, our review of your website http://www.clovecigs.com also revealed that you offer for sale to U.S. customers the following cigarettes, which are sold at your “Clove Cigarettes Online Store”: Bentoel Sejati; Bentoel Star Mild 16; Star Mild Menthol 16; Bintang Buana; Bintang Buana Raya; Class Mild 16; Djarum brand cigarettes; Djarum Black Cappuccino; Djarum Black Slimz; Djarum Black Tea; Djarum Black; Djarum Super 12; Djarum Super 16; Djarum Super Mild; Gudang Garam Signature Menthol; Gudang Garam Signature; Gudang Garam Surya 12; Gudang Garam Surya 16; Gudang Garam Surya Slim Menthol; Sampoerna A Mild 16; Sampoerna A Mild 12; Sampoerna A Mild Menthol 16; Sampoerna Avolution; Sampoerna Avolution Menthol; Sampoerna Dji Sam Soe brand cigarettes. These cigarettes are purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
 
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice…that is a characterizing flavor of the tobacco product or tobacco smoke. 
 
As of September 22, 2009, cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.
 
If, however, these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) as their labeling is false and misleading because it makes the representation that the products contain clove, cardamom, cinnamon, cappuccino, tea, cherry, spice, or fruit as characterizing flavors of the tobacco products.
 
You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission.
 
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products.
 
Please note your reference number, RW120003, in your response and direct your response to the following address:
 
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850 
 
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov.   
 
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
 
 
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