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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Andy Winata 8/20/12

  

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

AUG 20, 2012

VIA UPS and Electronic Mail

 

Andy Winata
JL Empang Bahagia Raya No 16
Jelambar
Jakarta Barat
DKI, 11460
Indonesia
pauyong@gmail.com


WARNING LETTER

Dear Mr. Winata:

The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your websites, http://www.kretekindonesia.com, http://www.inacigarette.com, and http://www.inacigar.com, and determined that your cigarette products listed there are offered for sale to U.S. customers.  FDA believes these websites are affiliated with one another because each website lists your name, Andy Winata, as the person to whom money transfers should be addressed when paying for the cigarette products offered for sale on the websites.  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 the websites, http://www.kretekindonesia.com, http://www.inacigarette.com, and http://www.inacigar.com as being light and mild by referring to them as such in product advertising and adding the qualifiers “Lights” and “Mild” to the product names and descriptions.  Specifically, our review of your websites revealed that you offer for sale the following cigarettes on http://www.kretekindonesia.com:  Marlboro Menthol cigarettes, listed as “Marlboro Lights Menthol.”  Our review of your websites also revealed that you offer for sale the following cigarettes on http://www.inacigarette.com and http://www.inacigar.com: Djarum L.A. Light cigarettes listed as “Djarum LA Light Mild” and described as a “…mild version of Djarum’s sweet pleasure”; Dunhill cigarettes listed as “Dunhill Lights”;; Gudang Garam Surya Premium 12, Gudang Garam Surya Professional Mild 16, Gudang Garam Surya Slim Menthol, and Gudang Garam Surya Slim cigarettes described as  “…selected with the highest quality tobaccos and cloves, the quality of mild clove cigarettes kretek filters”; Neslite cigarettes listed as “Neslite Mild”; and Sampoerna Flava cigarettes described as, “The First Mild Clove Cigarettes…”  You also describe products you offer for sale on your websites as containing reduced levels of substances.  Specifically, you describe L.A. Menthol Lights and L.A. Lights cigarettes on http://www.kretekindnesia.com as “…low tar low nicotine, machine-rolled kretek cigarette.”  Your websites http://www.inacigarette.com and http://www.inacigar.com also display the following description for Djarum LA Light cigarettes: “Although lower in tar and nicotine, the rich taste is not compromised.”

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 “Light” and “Mild” or similar descriptors for the above-listed products, and include claims that the 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 the following cigarettes on http://www.kretekindonesia.com:  Djarum Black Cappuccino, Djarum Black Tea, Djarum Black (“filter clove cigarettes” and “spicy aromatic-taste”), Gudang Garam Merah 12 (“clove cigarettes”), Gudang Garam Surya 12 (“the taste of the fine blend of tobacco and clove…”), L.A. Lights (“finely ground tobacco and cloves are mixed…to yield its unique flavor”), and Marlboro Kretek cigarettes (“…blended with …cloves….sweet &spicy”).  Our review of your websites also revealed that you offer for sale the following cigarettes on http://www.inacigarette.com and http://www.inacigar.com:  Aroma (“non filter clove cigarettes”),  Djarum Black Cappuccino, Djarum Black Tea, Djarum Cherry, Djarum Black (“filter clove cigarettes” and “spicy aromatic-taste”), Djarum LA Light Menthol (“…blended tobacco and clove a born comfortable taste…”), Djarum Mr. Brown (“clove cigarettes”), Djarum Super 12 (“fruity aromatic flavor”), Djarum Super 16 (“fruity aromatic flavor”), Djarum Super MLD (“filter clove cigarettes”), Gudang Garam Merah (“…clove and tobacco create a distinctive original flavor and taste…”), Gudang Garam Surya Premium 12 (“…mild clove cigarette kretek filters”), Gudang Garam Surya Professional Mild 16 (“…mild clove cigarette kretek filters”), Gudang Garam Surya Slim Menthol (“…mild clove cigarette kretek filters”), Gudang Garam Surya Slim (“…mild clove cigarette kretek filters”), Neo Mild (“filter clove cigarettes”), Neslite Menthol (“filter clove cigarettes”), Neslite Mild (“filter clove cigarettes”), Envio (“filter clove cigarettes”), Umild (“filter clove cigarettes”), Sejati (“filter clove cigarettes”), Star Mild Cool Menthol (“clove cigarettes”), Star Mild (“filtered clove cigarettes”), and Sampoerna Flava (“…mild clove cigarettes…”) 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, 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 these websites, 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 on these websites, and any other websites that you own, operate, or control. Your response should include a list of all corrected or discontinued websites and other promotional activity and your plan for maintaining compliance with the FD&C Act.

Please note your reference number, RW1200025, 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:

PT. Group Rokok Abadi
myhandyhalim@gmail.com 
an.winata@gmail.com
cassenwen@gmail.com

PT. Mitra Lestari
cassenwen@gmail.com
chocolatte.choo@gmail.com

PrivacyProtect.org
contact@privacyprotect.org

PT. Kabut Terang
a@a.com

UK2 Group LTD
c/o Ben Gabler
support@resell.biz

Directiplex
compliance@publicdomainregistry.com