| Public Health Service Food and Drug Administration |
| Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD 20850-3229 |
Department of Health and Human Services
VIA UPS and Electronic Mail
JUL 13 2011
Wayan Sumartini Saraswati
c/o Nyoman Manik Ariyasa
Br. Tebongkang Singakerta Ubud,
Gianyar, Bali, 80511, ID
WARNING LETTER
Dear Sir or Madam:
The Food and Drug Administration (FDA) recently reviewed your websites, http://www.balicigarette.com and http://www.clovecigarettesmarket.com, and determined that the 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(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.
Our review of your websites revealed that you offer for sale the following cigarettes, which are purported to contain the artificial or natural flavor clove as a characterizing flavor of the products: Avolution Menthol Slims Mild 16, Avolution Mild 16, Bentoel Biru, Bentoel Sejati Kretek, Cigarillos, Clas Mild 12, Clas Mild 16, Country_lights 20, Country_red 20, Crystal Special, Dana Super Kretek, Djarum 76 Kretek – 12, Djarum 76 Kretek – 16, Djarum Black – 16, Djarum Black Cappuccino – 16, Djarum Black Menthol, Djarum Black Slimz – 16, Djarum Black Tea, Djarum L.A. Lights 16, Djarum L.A. Menthol Lights 16, Djarum Super 12, Djarum Super 16, Dji Sam Soe Filter, Dji Sam Soe Gold, Dji Sam Soe Kretek 12, Dji Sam Soe Kretek 16, Dji Sam Soe Premium, Dji Sam Soe Premium Magnum, Dunhill Filter 20, Dunhill Lights 20, Dunhill Menthol 20, Dunhill Menthol Lights 20, Gudang Garam International, Gudang Garam Professional, Gudang Garam Signature, Gudang Garam Signature Menthol Mild 20, Gudang Garam Signature Mild 20, Gudang Garam Surya 12, Gudang Garam Surya 16, Gudang Garam Surya Pro Mild, Gudang Garam Surya Slims 12 Red, Gudang Garam Surya Slims 12 White, Gudang Garam Surya Slims 16 Red, Gudang Garam Surya Slims 16 White, Gudang Garam Surya Slims Menthol 12, Gudang Garam Surya Slims Menthol 16, In Mild, Laguna, Lucky Strike Filter 20, Lucky Strike Lights, Lucky Strike Menthol Lights, Marlboro Black Menthol, Marlboro Lights, Marlboro Lights Menthol, Marlboro Menthol, Marlboro Merah, Mr. Brown 12, Mr. Brown 16, Nikki Super 12, Nikki Super 16, Niko International 12, Niko International 16, Pall Mall Filter 20, Pall Mall Lights 20, Pall Mall Menthol Lights 20, Sampoerna A Hijau Kretek (Geser), Sampoerna A Mild 12, Sampoerna A Mild 16, Sampoerna Menthol, Star Mild 16, Star Mild Cool Menthol 16, Sukun Executive, Tali Jagat Filter, Tali Jagat Raya, U Mild, Ultra Special, Up Mild, Up Mild Menthol 16, Wismilak Diplomat 12, Wismilak Diplomat 16, X Mild. Specifically, you offer the above-listed cigarettes for sale using the descriptor “clove cigarettes” for each product, and you use the statements “Indonesian Clove Cigarettes Online Store” and “Easy way to Buy Indonesian Clove Cigarettes” to promote these products generally as flavored cigarettes. In addition, your “Djarum Black Cappuccino – 16” cigarettes are purported to contain not only clove, but also cappuccino as a characterizing flavor.
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 clove and clove/cappuccino 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 and/or clove and cappuccino as a characterizing flavor 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.
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.
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/
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
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