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  1. Warning Letters

WARNING LETTER

www.cigoutlet.net


Delivery Method:
Electronic Mail

Recipient:
www.cigoutlet.net


United States

Issuing Office:
Center for Tobacco Products

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

SEPT 15, 2015

VIA Electronic Mail
 
Khakhin Dmytro
support@cigoutlet.net; cigars@cigoutlet.net
 
 
WARNING LETTER
 
Dear Mr. Dmytro:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.cigoutlet.net and determined that the cigarette products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (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 cigarette products areadulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. Additionally, FDA has determined that several cigarette 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)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor.
                                                                                                                                    
Modified Risk Tobacco Product Violations
 
Our review of the website, http://www.cigoutlet.net, revealed that you sell or distribute the cigarette products listed or described as being lights, mild, or using similar descriptors. Specifically, our review of your website revealed that you sell or distribute cigarette products under the heading “Lights Cigarettes,” for example: Bond Lights (Special Selection), Camel Lights (Blue), Davidoff Slim Lights (Gold) 100’s, Kent Lights Nr. 1 (Infina), L&M Lights (Blue), Marlboro Lights (Gold), Parliament Lights (Aqua Blue), Sobranie Blue, Winston Lights (Balanced Blue), Classic Blue, Davidoff iD Blue, Dunhill Fine Cut Dark Blue 100’s, Gauloises Blue (Filter), Golden Gate Blue, Kent HDi Blue, L&M Motion Blue (mini), LD Blue, Lucky Strike Lights (Blue), Magna Blue (Lights), Marlboro Blue Fresh (Menthol), Monte Carlo Blue 100’s, Pall Mall Blue (Lights) (also described as “lights”), Pall Mall Lights (Blue), and Peter I Lights N8.  
 
You also sell or distribute cigarette products under the heading “Ultra Lights Cigarettes,” for example: Kent Super Lights Nr. 4 (Neo), L&M Super Lights (Silver Label), Parliament Extra Lights (Silver Blue), Sobranie Classic Silver, West Silver Compact, Winston Super Lights (Subtle Silver), Bond Super Slims Silver 100’s, Camel Super Lights (Silver), Classic Slims Silver, Davidoff Super Slims Silver, Kent HDs Silver Super Slims 100s, L&M Motion Silver (mini), LD Silver Cigarettes, Lucky Strike Original Silver, Marlboro Ultra Lights (Silver) (also described as “milder”), More Super Lights (Subtle Silver), Muratti Silver Slims 100’s, Pall Mall Super Slims Silver 100’s, Peter I Super Lights N4, Prima Lux Silver, R1 Ultra Slim Line, Rothmans Silver, Russian Style Super Lights, Sobranie Classic Ultra, Sovereign Slim Ultra Lights 100’s, West Silver Fusion, West Ultra, and Winston XSence Silver (mini). 
 
Additionally, our review of your website revealed that you offer for sale or distribute the following cigarette products: Beratt XL (described as “light”); and Chesterfield Agate Super Slims 100’s, Chesterfield Ivory Super Slims 100’s, and Chesterfield Red (Classic) (described as “mild”). 
 
In addition, you sell or distribute cigarette products on the website that are described as containing a reduced level of a substance, presenting a reduced risk of exposure to a substance, or as being less harmful than one or more other commercially marketed products. Specifically, the website describes cigarettes that are listed under the heading “Lights Cigarettes” as “‘low-tar,’ ‘mild,’ or ‘low-yield’ cigarettes” and as having “filter[s that are] perforated with small holes that vaporize the tobacco smoke with clean air.” You also offer for sale or distribute cigarette products listed under the heading “Ultra Lights Cigarettes,” which are described as, “produc[ing] the minimum content of nicotine and tar.  The effect is achieved by special filters laced with holes which diffuse the tobacco smoke with clean air. These perforations are designed to prevent the smoker from ingesting the full amount of nicotine and tar while smoking” and as having “the diluted smoke [that] doesn’t irritate the throat.”  
 
You also offer for sale or distribute the following cigarettes products on the website: Aroma Rich Apple cigarettes, described as having “low levels of nicotine”; Marlboro Ultra Lights (Silver) cigarettes, described as having a “filter [that] is penetrated with holes which diffuse the tobacco smoke with fresh air. Thus the smoker is prevented from ingesting the full amount of nicotine,” and having “much less nicotine and tar content than Marlboro Red. The tobacco is milder, the test is really smooth and does not irritate the throat” and “minimum harm to human health”; Style brand, described as having “less tar, less nicotine, less smoke”; and Virginia brand, described as “reduc[ing] the amount of smoke.”
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” “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)). 
 
The above listed products are modified risk tobacco products because website uses the descriptors light, mild, or similar descriptors to describe these products or as containing a reduced level of a substance, presenting a reduced risk of exposure to a substance, or as being less harmful than one or more other commercially marketed products for the above listed products. Because these products are sold or distributed 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)).
 
Flavored Cigarette Violations
 
Additionally,our review of the website, http://www.cigoutlet.net, revealed that you offer for sale or distribute the following cigarette products:Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Mohito (mini) (sic), Kiss Super Slims Clubnichka 100’s (strawberry), Kiss Super Slims Fresh Apple, Richmond Cherry, Richmond Cherry 4, Richmond Cherry Gold Super Slims 100s, Richmond Cherry Super Slims 100s, and Sobranie Slims Mints 100s. These products arepurported to contain an artificial or natural flavor that is a characterizing flavor 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 . . . that is a characterizing flavor of the tobacco product or tobacco smoke.
 
Cigarettes that are distributed or 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 cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, these cigarette products 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 section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum & cherry, mojito, strawberry, mint, or cherry as a characterizing flavor of the tobacco products.
 
Conclusion and Requested Actions
 
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 labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise 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 import 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 labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Please note your reference number, RW1500379, in your response and direct your response to the following address:
 
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 
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
 
VIA Electronic Mail
 
cc:
 
Khakhin Dmytro
khakhindymtro@gmail.com
  
CSL Computer Service Lagenbach GmbH
d/b/a joker.com
abuse@joker.com
 
NetNucleus USA Inc
abuse@noc.privatedns.com