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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.balicigar.com 1/3/13

  

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

JAN 3, 2013

VIA UPS and Electronic Mail
 
Customer 0128260817
Contact Privacy Inc.
96 Mowat Avenue
Toronto, Ontario M6K 3M1 Canada
balicigar.com@contactprivacy.com
 
WARNING LETTER
 
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed the website, http://www.balicigar.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 the website, http://www.balicigar.com, as being mild by referring to them as such in product advertising and adding the qualifier “Mild Clove Cigarettes” to the product descriptions. Specifically, our review of your website revealed that you offer for sale the following cigarettes described as “Mild Clove Cigarettes”: “Sampoerna A Flava Click Mint 12.”   In addition, you describe several products that you offer for sale on your website as containing reduced levels of substances. For example, you describe “L.A. Lights 16” cigarettes as “lower in tar and nicotine,” and “U Mild 16” and “X Mild 16” cigarettes as “low tar and low nicotine 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)). 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 or 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 the website, http://www.balicigar.com, uses the descriptor “low” and “mild” or similar descriptors for the above-listed products and/or describes them as containing reduced levels of tar and nicotine, 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 the website, http://www.balicigar.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 product: “Ardath Specials 20” (clove), “Benson & Hedges Special Filter 20” (clove), “Country International 20” (clove), “Free Choice Clove Cigarettes Sample – 10 Packs” (clove), “Sampler packs Choice Clove Cigarettes in 5 Packs” (clove), “Bentoel Biru” (clove), “Crystal Special” (clove), “Djarum Black 12” (spice, clove),  “Djarum Black 16” (spice, clove), “Djarum Black Cappuccino 16” (cappuccino, clove), “Djarum Black Menthol 16” (clove), “Djarum Black Slimz 16” (clove), “Djarum Black Tea 16” (tea, clove), “Djarum Super 12” (fruit, clove), “Djarum Super 16” (fruit, clove), “Gudang Garam International” (clove), “Gudang Garam Professional 16” (clove), “Gudang Garam Signature 20” (clove), “Gudang Garam Surya 12” (clove), “Gudang Garam Surya 16” (clove), “Gudang Garam Surya Premium 12” (clove), “Gudang Garam Surya Slims 12 Red” (clove), “Gudang Garam Surya Slims 12 White” (clove), “Gudang Garam Surya Slims 16 Red” (clove), “Gudang Garam Surya Slims 16 White” (clove), “Gudang Garam Surya Slims Menthol 12” (clove), “Gudang Garam Surya Slims Menthol 16” (clove), “Mr Brown 12” (clove), “Nikki Super 12” (clove), “Nikki Super 16” (clove), “Niko International 12” (clove), “Sampoerna Dji Sam Soe Filter” (clove), “Sampoerna Dji Sam Soe Super Premium Magnum Filter” (clove), “Sukun Executive” (clove), “Tali Jagat Filter” (clove), “Ultra Special” (clove), “Wismilak Diplomat 12” (clove), “Wismilak Diplomat 16” (clove), “Asam Garam Kretek” (clove), “Bentoel Sejati Kretek” (clove), “Dana Super 12 Kretek” (clove), “Djarum 76 Kretek – 12” (clove), “Djarum 76 Kretek – 16” (clove), “Gudang Garam Djaja Kretek King Size 12” (clove), “Gudang Garam Merah Kretek King Size 12” (clove), “Sampoerna A Hijau Kretek” (clove), “Sampoerna Dji Sam Soe Kretek 12” (clove), “Sampoerna Dji Sam Soe Kretek 16” (clove), “Sampoerna Dji Sam Soe Kretek Gold 12” (clove), “Sampoerna Dji Sam Soe Kretek Super Premium – Case” (clove), “Sampoerna Dji Sam Soe Kretek Super Premium – Refill” (clove), “Sukun Orange Kretek” (orange, clove), “Tali Jagat Raya Kretek 12” (clove), “Clas Mild 16” (clove), “Clas Mild Menthol 16” (clove), “Djarum L.A. Lights 16” (clove), “Djarum L.A. Menthol Lights 16” (clove), “Gudang Garam Signature Menthol Mild 20” (clove), “Gudang Garam Signature Mild 20” (clove), “Gudang Garam Surya Professional Mild 16” (clove), “In Mild 16” (clove), “Laguna Mild Panorama Indonesia 16” (clove), “Relax Mild 16” (clove), “Sampoerna A Flava Click Mint 12” (mint, clove), “Sampoerna A Mild 12” (clove), “Sampoerna A Mild 16” (clove), “Sampoerna A Mild Menthol 16” (clove), “Sampoerna Avolution Menthol Slims Mild 16” (clove), “Sampoerna Avolution Slims Mild 16” (clove), “Star Mild 16” (clove), “Star Mild Cool Menthol 16” (clove), “U Mild 16” (clove), “Up Mild 16” (clove), “Up Mild Menthol 16” (clove), “Vegas Mild 16” (clove), and “X Mild 16” (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)) as their labeling is false and misleading because it makes the representation that the products contain clove, cappuccino, spice, tea, fruit, orange, ormint 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, RW1200048, 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:
mingtek99@hotmail.com
 
Tucow’s Inc.
info@tucows.com
 
The Endurance International Group, Inc.
netmon@maileig.com
bnbrock@maileig.com