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WARNING LETTER

http://www.cigs7.com


Recipient:
http://www.cigs7.com


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 

 

 

APR 14, 2015
 
To: support@cigs7.com
 
WARNING LETTER
 
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.cigs7.com, and determined that your cigarette, cigarette tobacco, and/or roll-your-own tobacco products listed there are distributed or 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 (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, cigarette tobacco, and roll-your-own tobacco, 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 cigarette, cigarette tobacco, and/or roll-your-own tobacco products are adulterated 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 of your 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Modified Risk Tobacco Product Violations
 
You sell or distribute cigarette, cigarette tobacco, and/or roll-your-own tobacco products that you describe on the website, http://www.cigs7.com, as being light or mild by referring to them as such in product labeling or advertising and adding the qualifiers “Light,” “Ultra Light,” “Premium Light,” “Super Light,” “mild,” “Low,” and/or similar descriptors to the product names.  Specifically, our review of the website revealed that you sell or distribute cigarettes, cigarette tobacco and/or roll-your-own tobacco listed as, for example: Berley (Berley Light Soft King), Bond Street Special Selection (Bond Lights (Special Selection)), Camel (Camel Lights), Davidoff (Davidoff Premium Light FSC), Esse Super Slims Menthol 100s (described as “mild”), Grand Prix (Grand Prix Light SP King), Lucky Strike Blue (Lucky Strike Lights (Blue)), L&M Silver Label (L&M Super Lights (Silver Label)), Marathon (Marathon Ultra Light Box 100), Marlboro Gold Original (Marlboro Lights (Gold)), Monte Carlo Blue 100’s (described as “light”), More (More Light White 120), Pall Mall (Pall Mall Ultra Lights (Amber)), Quest (Quest 1 Low Light Box King; Quest 2 Extra Low Box King), R1 Minima Slim Line 100’s (described as “mild” and “light”), Shield (Shield Light Soft 100), Silver (Silver Light Soft King), Sovereign Slims Ultra (Sovereign Slim Ultra Lights 100’s), Tahoe (Tahoe Light SP 100), Tareyton (Tareyton Light Soft 100), Tucson (Tucson Ultra Light SP 100), U.S.A. (U.S.A. Gold Light 100), Vantage (Vantage Ultra Light King), Viceroy (Viceroy Light King), Wave (Wave Light 100), and KY’s Best (KY’s Best RYO Light 16 oz.).
 
You also sell or distribute products that you describe as presenting a lower risk of tobacco-related disease or as being less harmful than one or more other commercially marketed products. Specifically, you offer for sale products listed as Parliament Lights (Aqua Blue) cigarettes, which you describe as “[t]he Light cigarettes contain low levels of tar, so they are mild and relatively harmless,” and Davidoff brand cigarettes, which you describe as having “filters [that] prevent harmful dust particles from entering the throat while smoking [that] makes Davidoff much safer and healthier to smoke than other cigarette brands.”
 
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 uses the descriptors “Light,” “Ultra Light,” “Premium Light,” “Super Light,” “mild,” “Low,” and/or similar descriptors, and claims of being “safer,” “healthier,” and “relatively harmless” for the above listed products, these products are modified risk tobacco 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.cigs7.com, revealed that you offer for sale cigarette products, including but not limited to the following: Aroma Rich Rum & Cherry, Kiss Mohito (mini), Kiss Super Slims Clubnichka 100’s (strawberry image), Kiss Super Slims Fresh Apple 100’s, Richmond Cherry, and Sobranie Slims Mints 100’s, which are purported 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.
 
As of September 22, 2009, cigarettes, cigarette tobacco, and roll-your-own tobacco 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 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, rum & cherry, mojito, strawberry, apple, or mint 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 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, RW1500281, 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:
 
Wang Zheng
NiceNIC International Group Co., Limited
privacy@iisp.com
support@nicenic.net
 
Guangdong Naisinike Information Technology Co. Ltd.
ZhuHai NaiSiNiKe Information Technology Co., Ltd.
support@nicenic.net
 
Irina Kuts
abuse@noc.privatedns.com