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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.kretekstore.com 12/6/12

  

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 

DEC 6, 2012

VIA UPS and Electronic Mail
 
To: L. Panditya Sukmanjaya
order@KretekStore.com
 
WARNING LETTER
 
Mr. Sukmanjaya:
 
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your website, http://www.kretekstore.com, and determined that your cigarette products listed there are offered for sale to U.S. customers. 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 on your website, http://www.kretekstore.com, as being mild by referring to them as such in product advertising and adding the qualifier “mild” to the product descriptions. Specifically, our review of your website revealed that you offer for sale the following cigarettes: Gudang Garam Surya Slim Menthol and Gudang Garam Surya Slim cigarettes described as  “the quality of mild clove cigarettes”; Sampoerna Flava cigarettes described as “The First Mild Cigarettes with a mint Boost”; and Sampoerna Avolution Menthol and Sampoerna Avolution cigarettes described as “the new mild generation”. In addition, your website describes Djarum LA Lights Menthol and Djarum LA Lights Mild 16 cigarettes as being “low tar 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)(i)) if its label, labeling, or advertising explicitly or implicitly represents such product or its smoke as containing a reduced level of a substance, presenting a reduced exposure to a substance, or represents such product as 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 website uses the descriptor “Mild” or similar descriptors for the above-listed products and include claims that the products or their smoke 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 website revealed that you offer for sale the following flavored cigarettes: “Bentoel Biru International,” “Bentoel Sejati,” “Class Mild 16,” “Djarum Black Cappuccino,” “Djarum Black Menthol,” “Djarum Black Tea,” “Djarum Black,” “Djarum Brown,” “Djarum Coklat,” “Djarum LA Lights Menthol,” “Djarum LA Lights Mild 16,” “Djarum Super 16,” “Djarum Super Mild,” “Gudang Garam International,” “Gudang Garam Merah,” “Gudang Garam Professional,” “Gudang Garam Signature,” “Gudang Garam Signature Menthol,” “Gudang Garam Surya 12,” “Gudang Garam Surya 16,” “Gudang Garam Surya Slim Menthol,” “Gudang Garam Surya Slim White 16,” “Gudang Garam Surya Slim,” “Sampoerna A Mild 12,” “Sampoerna A Mild 16,” “Sampoerna A Mild Menthol 16,” “Sampoerna Avolution Menthol,” “Sampoerna Avolution,” “Sampoerna Dji Sam Soe 234,” “Sampoerna Dji Sam Soe Magnum,” “Sampoerna Flava,” “Surya PROfessional MILD,” Wismilak Diplomat 12, “Wismilak Diplomat 16,” “Dunhill Filter 20,” “Dunhill Lights Menthol,” “Dunhill Lights,” “Lucky Strike Lights,” “Lucky Strike Menthol,” “Lucky Strike Original,” “Marlboro Black Menthol,” “Marlboro Menthol,” and “Marlboro Red” which 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, cappuccino, tea, cinnamon, 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, RW1200046, 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
 
VIA Electronic Mail
 
cc:
 
Stave Emanuel
Arava Bicycle Manufacturer PT
vkepep@gmail.com
 
Ahosting, Inc.
sales@ahosting.net