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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.indonesiastore.net, www.clovecigarette.org 4/12/13

  

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

 APR 12, 2013

VIA UPS and Electronic Mail
 
Putu Ari Irmayani
Jl. R.A. Kartini Gang Komodo 1 No 3
Mataram, NTB 83122
Indonesia
sales@indonesiastore.net
sales@indocigs.com
sales@clovecigarette.org
 
WARNING LETTER
 
Dear Ms. Irmayani:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites,http://www.indonesiastore.net, http://www.clovecigarette.org, and http://www.rokokkretek.com, and determined that your cigarette products listed there are offered for sale to customers in the United States. FDA believes these websites are affiliated with one another because they all list your name as the point of contact. 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 cigarettes 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)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Modified Risk Tobacco Product Violations
 
You describe products that you offer for saleon your websites http://www.indonesiastore.net, http://www.clovecigarette.org, and http://www.rokokkretek.com as being light or mild by referring to them as such in product labeling or advertising and adding the qualifiers “Mild” or “Light” to the product names. Specifically, our review of the websites http://www.indonesiastore.net and http://www.rokokkretek.com, revealed that you offer for sale products listed as: Djarum Black Menthol Supersmooth (“a lighter version of mentholated kretek”), Djarum Black Supersmooth (“a lighter version of Djarum Black”), Gudang Garam Surya Slim (“mild clove cigarettes”), Gudang Garam Surya Slim Menthol (“mild clove cigarettes”), Marlboro Menthol (“Marlboro Lights Menthol”), Sampoerna Avolution (“new mild generation”), Sampoerna Avolution Menthol (“new mild generation”), and Sampoerna Flava Click Mint (“Mild Cigarettes”) cigarettes. In addition, our review of the website http://www.clovecigarette.org revealed that you offer for sale products listed as: Gudang Garam Surya Slim (“mild clove cigarettes”), Gudang Garam Surya Slim Menthol (“mild clove cigarettes”), and Dunhill Blue (“Dunhill Light”). 
 
In addition, the products you offer for sale on the website, http://www.indonesiastore.net, contains the following descriptions: Bentoel X Mild (“low tar and low nicotine”), Djarum LA Lights Menthol (“low tar low nicotine”) and Djarum LA Lights Mild 16 (“low tar low nicotine”), and Dunhill cigarettes as containing(“less tar than Marlboros”). Similarly, you provide the following descriptions on http://www.clovecigarette.org: Djarum LA Lights Menthol (“low tar low nicotine”) and Djarum LA Light Mild (“low tar low nicotine” cigarettes. Additionally you provide the following descriptions on http://www.rokokkretek.com: Djarum LA Lights Menthol (“low tar low nicotine”), Djarum LA Lights Mild (“low tar low nicotine”), and Dunhill cigarettes as containing (“less tar than Marlboros”). 
 
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 that (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) such product or its smoke contains a reduced level of a substance, presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. 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” or “Light” or similar descriptors for the above-listed products or describe the products as containing reduced levels of tar and/or nicotine, 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)).
 
Flavored Cigarette Violations
 
revealed that you offer for sale the followingAdditionally, our review of your website http://www.indonesiastore.net cigarettes: “Bentoel Star Mild Menthol 16” (clove), “Bentoel Star Mild 16 Indonesia” (clove), “Bentoel Sejati Indonesia” (clove), “Bentoel Biru International” (clove), “Bentoel U Mild” (clove), and “Bentoel X Mild” (clove), “Djarum Super Mild” (clove), “Djarm Black Indonesia” (cinnamon, clove, spice), “Djarum Black Cappucino” (clove, cappuccino), Djarum Black Menthol Indonesia” (clove), “Djarum Black Slimz Indonesia” (clove, tea, spice), “Djarum 76 Indonesia” (clove), “Djarum Black Tea Indonesia” (clove, tea), “Djarum Brown Indonesia” (clove), “Djarum LA Lights Menthol” (clove), “Djarum Coklat Indonesia” (clove), “Djarum Super 12 Indonesia” (clove, fruit), “Djarum LA Lights Mild” (clove), “Djarum Super 16 Indonesia” (clove), “Djarum Cherry Indonesia” (clove, cherry, fruit), “Djarum Special Indonesia” (clove, fruit), “Djarum Black Supersmooth” (clove), “Djarum Supersmooth Indonesia” (clove), “Djarum Black Menthol Supersmooth” (clove), “Djarum Splash Indonesia” (clove), “Djarum Bali Hai Indonesia” (clove), “Djarum Vanilla Indonesia” (clove, vanilla), “Djarum Menthol Indonesia” (clove), and “Djarum Black Mild” (clove), “Gudang Garam Surya Slim White 12” (clove), “Gudang Garam Surya Slim White 16” (clove), “Gudang Garam Merah Indonesia” (clove), “Gudang Garam Surya 12 Indonesia” (clove), “Gudang Garam Surya 16 Indonesia” (clove), “Gudang Garam Surya Slim” (clove), “Gudang Garam Surya Slim Menthol” (clove), “Gudang Garam International” (clove), “Gudang Garam Professional” (clove), “Gudang Garam Signature Indonesia” (clove), and “Gudang Garam Signature Menthol” (clove), “Marlboro Kretek 12 Mix 9” (clove), “Apache 12 Kretek Filter” (clove), “Club Mild” (clove), “Gudang Garam Pro Mild” (clove), “Intro Mild” (clove), “Neo Mild” (clove), “Uno Mild” (clove), “Vegas Mild” (clove), “Dji Sam Soe Classic Indonesia” (clove), “Sampoerna A Mild 12 Indonesia” (clove), “Sampoerna A Mild 16 Indonesia” (clove), “Sampoerna Dji Sam Soe 234” (clove), “Sampoerna Avolution Menthol” (clove), “Sampoerna Avolution Indonesia” (clove), “Sampoerna A Mild Menthol 16” (clove), “Dji Sam Soe Kretek 16 Indonesia” (clove), “Sampoerna Dji Sam Soe Magnum” (clove), “Dji Sam Soe Gold” (clove), “Sampoerna Flava Click Mint” (mint, clove), “Dji Sam Soe 234 99 Anniversary” (clove), “Wismilak Diplomat 12 Indonesia” (clove), “Wismilak Diplomat 16 Indonesia” (clove), and “Wismilak Kretek Indonesia” (clove) cigarettes.  On your website http://www.clovecigarette.org, you also offer for sale the following cigarettes: “Apache 12 Kretek filter” (clove), “Bentoel Biru International” (clove), “Bentoel Sejati” (clove), “Djarum Black Clove” (cinnamon, clove), “Djarum Black Cappuccino Clove” (cappuccino, clove), “Djarum Black Menthol Clove” (clove), “Djarum Black Slimz Clove” (clove, spice), “Djarum 76 Clove” (clove), “Djarum Black Tea Clove” (tea, clove), “Djarum Brown Clove” (clove), “Djarum LA Lights Menthol Clove” (clove), “Djarum LA Light Mild Clove” (clove), “Djarum Super 12 Clove” (clove), “Djarum Super 16 Clove” (clove), “Djarum Coklat Clove” (clove), “Djarum Cherry Clove” (cherry, clove), “Djarum Special Clove” (clove, spice), “Djarum Black Supersmooth Clove” (clove), “Djarum Supersmooth Clove” (clove), “Djarum Black Menthol Supersmooth Clove” (clove), “Djarum Splash Clove” (clove), “Djarum Bali Hai Clove” (clove), “Djarum Vanilla Clove” (vanilla, clove), “Djarum Menthol Clove” (clove), “Gudang Garam Surya Slim White 12 Clove” (clove), “Gudang Garam Surya Slim White 16 Clove” (clove), “Gudang Garam Surya Slim Clove” (clove), “Gudang Garam Surya Slim Menthol Clove” (clove), “Gudang Garam Surya 12 Clove” (clove), “Gudang Garam International Clove” (clove), “Gudang Garam Merah Clove” (clove), “Gudang Garam Professional Clove” (clove), “Gudang Garam Signature Clove” (clove), “Gudang Garam Signature Menthol” (clove), “Gudang Garam Surya 16” (clove), “Marlboro Red Clove” (clove), “Marlboro Kretek 12 Mix 9 Clove” (clove), and “Marlboro Black Menthols Clove” (clove). Similarly, on your website http://www.rokokkretek.com, you offer for sale the following cigarettes: “Bentoel Star Mild Menthol 16” (clove), “Bentoel Star Mild 16” (clove), “Bentoel Sejati” (clove), “Bentoel Biru International” (clove),“Djarum Black” (clove, spice), “Djarum Black Cappuccino” (cappuccino, clove), “Djarum Black Menthol” (clove), “Djarum Black Slimz” (clove, spice), “Djarum Black Tea” (tea, clove), “Djarum 76” (clove), “Djarum Brown” (clove), “Djarum Coklat” (clove), “Djarum LA Lights Menthol” (clove), “Djarum LA Lights Mild 16” (clove), “Djarum Super 12” (clove, fruit), “Djarum Super 16” (clove), “Djarum Bali Hai” (clove), “Djarum Cherry” (cherry, clove), “Djarum Special” (clove), “Djarum Black Supersmooth” (clove), “Djarum Supersmooth” (clove), “Djarum Black Menthol Supersmooth” (clove), “Djarum Splash” (clove), “Djarum Vanilla” (vanilla, clove), “Djarum Menthol” (clove),“Gudang Garam Surya Slim White 12” (clove), “Gudang Garam Surya Slim White 16” (clove), “Gudang Garam Merah” (clove), “Gudang Garam Surya 12” (clove), “Gudang Garam Surya Slim Menthol” (clove), “Gudang Garam Surya Slim” (clove), “Gudang Garam Professional” (clove), “Gudang Garam International” (clove), “Gudang Garam Signature” (clove), “Gudang Garam Signature Menthol” (clove), “Gudang Garam Surya 16” (clove), “Marlboro Kretek 12” (clove), “Dji Sam Soe Classic” (clove), “Sampoerna A Mild 12” (clove), “Sampoerna A Mild 16” (clove), “Sampoerna A Mild Menthol 16” (clove), “Sampoerna Avolution” (clove), “Sampoerna Avolution Menthol” (clove), “Sampoerna Dji Sam Soe 234” (clove), “Dji Sam Soe Kretek 16” (clove), “Sampoerna Dji Sam Soe Magnum” (clove), “Dji Sam Soe Gold” (clove), “Sampoerna Flava” (mint, clove), “Wismilak Diplomat 12” (clove), “Wismilak Diplomat 16” (clove), and “Wismilak Kretek” (clove) cigarettes. These cigarettes are purported to contain an artificial or natural flavor that is a characterizing flavor of the product(s). 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)) or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, clove, cinnamon, spice, cappuccino, tea, fruit, mint, vanilla, or cherry as a characterizing flavor of the tobacco products.
 
Conclusion and Requested Actions
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 
 
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, or any other websites or media in which you advertise comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.  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 and your plan for maintaining compliance with the FD&C Act.
 
Please note your reference number, RW1300069, 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 CTPCompliance@fda.hhs.gov.   
 
 
Sincerely,
/S/ 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
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