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U.S. Department of Health and Human Services

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Enforcement Actions

www.djarumblack-clovecigarettes.com 3/7/13

  

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  

March 7, 2013

VIA Electronic Mail
 
To: support@djarumblack-clovecigarettes.com
 
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.djarumblack-clovecigarettes.com, and determined that your cigarette products listed there are offered for sale to customers in the United States. 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.  FDA has also 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)) or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). Additionally, FDA has determined that several of your products are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act (21 U.S.C. §387c(a)(7)(B)) because you are selling them in violation of section 21 C.F.R. §1140.16(b). 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 on the website, http://www.djarumblack-clovecigarettes.com, as being mild by referring to them as such in product labeling or advertising and adding the qualifier “mild” to the product descriptions. Specifically, our review of the website, http://www.djarumblack-clovecigarettes.com, revealed that you offer for sale the following cigarettes described as “Cloves Mild”: “Djarum Black Menthol,” “Djarum Black Tea,” “Sampoerna Avolution,” “Djarum Black Cappuccino,” and “Sampoerna Avolution Menthol.” You also describe products you offer for sale on your website as containing reduced levels of substances. Specifically, you describe “Bentoel Star Mild” and “Bentoel Star Mild Menthol” as “ low tar and low nicotine clove cigarette”; “Djarum Envio Mild,” “Djarum L.A Lights,” and “Djarum L.A Menthol Lights” as a “low tar low nicotine, machine-rolled kretek cigarette”; and “Djarum Super12 / Special,” and “Djarum Super16 (Special) as containing “significantly less tar, nicotine and carbon monoxide (levels comparable to regular cigarette) than the other commercially popular Djarum brands in the West.” 
 
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) the 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 website uses the descriptor “mild” or similar descriptors for the above listed products and/or describes them as containing reduced levels of tar, nicotine, and/or carbon monoxide, these products are modified risk tobacco products. Because these products are offered for sale to customers in the United States 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)).
 
In addition, our review of the website, http://www.djarumblack-clovecigarettes.com, revealed that you offer for sale the following cigarettes, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products: “Bentoel Biru” (clove), “Bentoel Class Mild” (clove), “Bentoel Class Mild Menthol” (clove), “Bentoel Sejati” (clove), “Bentoel Star Mild” (clove), “Bentoel Star Mild Menthol” (clove), “Djarum 76” (clove), “Djarum Bali Hai” (clove), “Djarum Black” (clove), “Djarum Black Cappuccino” (clove and capuccino) “Djarum Black Menthol” (clove), “Djarum Black Mild” (clove), “Djarum Black Slimz” (clove), “Djarum Black Tea” (clove and tea), “Djarum Brown” (clove), “Djarum Cherry” (clove and cherry), “Djarum Coklat” (clove), “Djarum Coklat Extra” (clove), “Djarum Envio Mild” (clove), “Djarum L.A Lights” (clove), “Djarum L.A Lights Menthol” (clove), “Djarum Menthol” (clove), “Djarum Special” (clove), “Djarum Super12 / Special” (clove), “Djarum Super16 (Special)” (clove), “Djarum Super Mild” (clove), “Gudang Garam International” (clove), “Gudang Garam Merah” (clove), “Gudang Garam Professional” (clove), “Gudang Garam Signature” (clove), “Gudang Garam Signature Lights” (clove), “Gudang Garam Signature Menthol” (clove), “Gudang Garam Surya 12” (clove), “Gudang Garam Surya 16” (clove), “Gudang Garam Surya PROfessional mild” (clove), “Sampoerna Avolution” (clove), “Sampoerna Avolution Menthol” (clove), “Sampoerna DjiSamSoe Refill” (clove), “Sampoerna Magnum” (clove), “Sampoerna Mild” (clove), and “Sampoerna Mild Menthol” (clove). 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 and misleading because it makes the representation that the products contain, for example, clove, cappuccino, cherry, or tea as a characterizing flavor of the tobacco products.
 
Additionally, our review of the website, http://www.djarumblack-clovecigarettes.com revealed that you offer for sale the following individual cigarette packages which contain 16 cigarettes per package: “Bentoel Class Mild,” “Bentoel Class Mild Menthol,” “Bentoel Star Mild,” “Bentoel Star Mild Menthol,” “Djarum Black,” “Djarum Black Cappuccino,” “Djarum Black Menthol,” “Djarum Black Mild,” “Djarum Black Slimz,” “Djarum Black Tea,” “Djarum Envio Mild,” “Djarum L.A Lights,” “Djarum L.A Lights Menthol,” “Djarum Super16 (Special),” “Djarum Super Mild,” “Gudang Garam International,” “Gudang Garam Professional,” “Gudang Garam Surya PROfessional Mild,” “Gudang Garam Surya 16,” “Sampoerna Mild,” “Sampoerna Mild Menthol,” “Sampoerna Avolution,” and “Sampoerna Avolution Menthol.” In addition, you offer for sale the following individual cigarette packages which contain 12 cigarettes per package: “Bentoel Biru,” “Bentoel Sejati,” “Djarum 76,” “Djarum Brown,” “Djarum Coklat,” “Djarum Coklat Extra,” “Djarum Menthol,” “Djarum Super12 / Special,” “Gudang Garam Merah,” “Gudang Garam Surya 12,” “Sampoerna DjiSamSoe Refill,” and “Sampoerna Magnum.” Under section 21 C.F.R. §1140.16(b), no retailer may sell or cause to be sold any cigarette package that contains fewer than 20 cigarettes to U.S. customers. Cigarettes that are sold to customers in the United States in violation of 21 C.F.R. §1140.16(b) are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
 
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 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, RW1300058, 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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