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U.S. Department of Health and Human Services

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Enforcement Actions

www.ciggiesworld.com 1/29/13

  

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 29, 2013

VIA USPS, andElectronic Mail
 
CiggiesWorld
Attn: Jeffrey Lee
Canberra GPO Post Shop
GPO Box 1620
Australia ACT 2601
Support@CiggiesWorld.com
 
 
WARNING LETTER
Dear Mr. Lee:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website http://www.ciggiesworld.com, and determined that your cigarette products listed there are offered for sale to customers in the United States. 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.  FDA has also 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 sections 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). Additionally, FDA has determined that several of your products are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) for selling cigarettes in violation of section 21 C.F.R. §1140.16(b). 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.ciggiesworld.com, as being mild by referring to them as such in product labeling or advertising and adding the qualifier “mild” to the product names and descriptions. Specifically, our review of your website, http://www.ciggiesworld.com, revealed that you offer for sale products listed as: Dunhill Fine Cut Infinite listed as “Dunhill Fine Cut - MILD”; Sampoerna Avolution described as “…the new generation mild cigarette”; Sampoerna Avolution Menthol described as “…the new mild generation”; and Sampoerna Flava described as “The First Mild Clove Cigarettes….” You also describe products you offer for sale on your website as containing reduced levels of substances. Specifically, you describe Bentoel One Mild and X Mild as “a low tar and low nicotine clove cigarette”; Bentoel Club Mild as “a premium low tar and low nicotine clove cigarette”; Bentoel Star Mild as “ultimate satisfaction of low tar and nicotine cigarettes”; Djarum Envio Mild, Djarum L.A. Lights, and Djarum L.A. Lights Menthol as a “low tar low nicotine, machine-rolled kretek cigarette”; Seven Stars Charcoal Filter as “low tar”; and U Mild by Marlboro as “the perfect blend of low tar and low nicotine mild clove 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 your website uses the descriptor “Mild” or similar descriptors for the above listed products, and includes claims that the above listed products  contain a reduced level of a substance, these products are modified risk tobacco products. Because these products are offered for sale to customers in the United States 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)).
 
In addition, our review of your website, http://www.ciggiesworld.com, revealed that you offer for sale the following cigarettes that are described as “Clove Cigarettes (Kretek)”: “Bentoel Blue,” “Bentoel Class Mild,” “Bentoel Club Mild,” “Bentoel One Mild,” “Bentoel Sejati,” “Bentoel Star Mild,” “Bentoel Tali Jagat Raya,” “neO Mild by Bentoel,” “unO Mild by Bentoel,” “Star Mild Menthol,” “X Mild by Bentoel,” “Djarum 76,” “Djarum 76 Gold Filtered,” “Djarum Bali Hai,” “Djarum Black,” “Djarum Black Cappuccino,” “Djarum Black Menthol,” “Djarum Black Mild,” “Djarum Black Slimz,” “Djarum Brown,” “Djarum Cherry,” “Djarum Coklat,” “Djarum Coklat Extra,” “Djarum Envio Mild,” “Djarum L.A. Lights,” “Djarum L.A. Lights Menthol,” “Djarum Menthol,” “Djarum MLD,” “Djarum Special,” “Djarum Splash,” “Djarum Super,” “Djarum Super Mezzo,” “Djarum Supersmooth,” “Djarum Vanilla,” “Gudang Garam International,” “Gudang Garam International Canned,” “Gudang Garam Merah,” “Gudang Garam Neslite,” “Gudang Garam Neslite Menthol,” “Gudang Garam Nusantara,” “Gudang Garam Nusantara Menthol,” “Gudang Garam Professional,” “Gudang Garam ProMild,” “Gudang Garam Signature Lights,” “Gudang Garam Signature Menthol,” “Gudang Garam Signature Original,” “Gudang Garam Surya 12,” “Gudang Garam Surya 12 Premium,” “Gudang Garam Surya 16,” “Gudang Garam Surya Exclusive,” “Gudang Garam Surya Slim,” “Gudang Garam Surya Slim Menthol,” “Gudang Garam Surya Slim White,” “Sampoerna 234 Limited Edition (Tin Case),” “Sampoerna A Mild,” “Sampoerna A Mild Menthol,” “Sampoerna Avolution,” “Sampoeran Avolution Menthol,” “Sampoerna Dji Sam Soe 234,” “Sampoerna Dji Sam Soe Filter,” “Sampoerna Dji Sam Soe Magnum,” “Sampoerna Dji Sam Soe Super Premium,” “Sampoerna Flava,” “U Mild by Marlboro,” “Wismilak Diplomat,” and “Wismilak Green Non-Filtered.”  Additionally, your website offers for sale the following cigarettes: “DJ MIX – Iced Green Apple,” “DJ MIX Menthol – Strawberry,” “Dunhill International (London – UK)” described as “Spicy, with a hint of sweetness,” “Marlboro Ice Mint,” and “Peel Orange Menthol.” 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)) or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false and misleading because it makes the representation that the products contain, for example, clove, cappuccino, cherry, fruit, spice, vanilla, apple, strawberry, mint, or orange as a characterizing flavor of the tobacco products.
 
Additionally, our review of your website revealed that you offer for sale the following individual cigarette packages which contain 16 cigarettes per package: “Bentoel Blue,” “Bentoel Class Mild,” “Bentoel Club Mild,” “Bentoel One Mild,” “Bentoel Sejati,” “Bentoel Star Mild,” “Star Mild Menthol,” “unO Mild by Bentoel,” “X Mild by Bentoel,” “Djarum 76 Gold Filtered,” “Djarum Black,” “Djarum Black Cappuccino,” “Djarum Black Menthol,” “Djarum Black Mild,” “Djarum Black Slimz,” “Djarum Coklat,” “Djarum Coklat Extra,” “Djarum Envio Mild,” “Djarum L.A Lights,” “Djarum L.A Lights Menthol,” “Djarum MLD,” “Djarum Splash,” “Djarum Super,” “Djarum Super Mezzo,” “Gudang Garam Professional,” “Gudang Garam ProMild,” “Gudang Garam Surya 16,” “Gudang Garam Surya Exclusive,” “Gudang Garam Surya Slim,” “Gudang Garam Surya Slim Menthol,” “Gudang Garam Surya Slim White,” “Sampoerna A Mild,” “Sampoerna A Mild Menthol,” “Sampoerna Avolution,” “Sampoerna Avolution Menthol,” “Sampoerna Dji Sam Soe Magnum,” “Sampoerna Flava,” “U Mild by Marlboro,” and “Wismilak Diplomat.” In addition, you offer for sale the following individual cigarette packages which contain 12 cigarettes per package: “Bentoel Tali Jagat Raya,” “Djarum 76,” “Djarum Brown,” “Gudang Garam International,” “Gudang Garam Merah,” “Gudang Garam Surya 12,” “Gudang Garam Surya 12 Premium,” “Sampoerna Dji Sam Soe 234,” “Sampoerna Dji Sam Soe Filter,” “Sampoerna Dji Sam Soe Super Premium,” and “Wismilak Green Non-Filtered.” Under section 21 C.F.R. §1140.16(b) no retailer may sell or cause to be sold any cigarette package that contains fewer than 20 cigarettes. Cigarettes that are sold to customers in the United States in violation of section 21 C.F.R. §1140.16(b) are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). 
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 
 
It is your responsibility to ensure that your tobacco products and all related promotional materials comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. 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 and your plan for maintaining compliance with the FD&C Act.
 
Please note your reference number, RW1300055, 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 CTPCompliance@fda.hhs.gov.     
 
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
cc:
sales@ciggiesworld.com
 
Atoms Alliance Pty Ltd
stockwood69@yahoo.com
 
name.com LLC
support@name.com