Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Center for Tobacco Products
VIA UPS and Electronic Mail
JI. Cokroaminoto Street 4
Denpasar, Bali 80118
OCT 31 2011
Dear Sir or Madam:
The Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) recently reviewed the website, http://www.indocigs.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 your Dunhill cigarettes in a light blue pack and your Djarum L.A. cigarettes 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 all of your clove 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 )). 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.indocigs.com, as being light or mild by referring to them as such in product advertising, and adding the qualifiers "Light" and "Mild." Specifically, our review of your website revealed that you offer for sale "Dunhill Light" and "Djarum L.A. Light Mild" cigarettes.
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)). 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 descriptors "Light" and "Mild" for the above-listed 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, http://www.indociqs.com, revealed that you offer for sale the following flavored cigarettes that you refer to in your product advertising as "clove-infused," "made with high quality tobaccos and cloves," "finest tobacco and clove combinations," "addition of fine natural cloves," "hand-rolled clove cigarette," and/or "blend of first quality tobacco and clove": "Marlboro Kretek 12," "Djarum Bali Hai," "Djarum Cherry," "Djarum LA Light Mild," "Djarum LA Light Menthol," "Djarum Super 12," ’Djarum Super 16," "Djarum Black Tea," "Djarum 76," "Djarum Black Slimz," "Djarum Black Menthol," "Djarum Black Cappuccino," "Djarum Black," "Djarum Brown 12," "Gudang Garam Surya Slim," "Gudang Garam Surya Slim Menthol," "Gudang Garam Surya 12," "Gudang Garam Signature," "Gudang Garam Merah," ’Gudang Garam International," "Dji Sam Soe Classic," "Sampoerna A Mild 12," "Sampoerna A Mild 16," "Sampoerna Dji Sam Soe 234," "Sampoerna A Mild Menthol 16," "Sampoerna Dji Sam Soe Magnum," "Bentoel Star Mild Menthol 16," "Bentoel Star Mild 16," "Bentoel Sejati""Wismilak Diplomat 12," and "Wismilak Diplomat 16," which are purported to contain clove and in some cases cherry, team, and cappauccino, artificial or natural flavors that are characterizing flavors of the products. 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, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, 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 cappuccino, cherry, clove, or tea 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 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 lbarra-Pratt at (301) 796-9235 or via email at Elenita.lbarraPratt@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products