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WARNING LETTER

www.cheapcigarettes.com 30/12/2015

www.cheapcigarettes.com - 12/30/2015


Delivery Method:
Electronic Mail

Recipient:
www.cheapcigarettes.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 

 

 DEC 30, 2015

VIA Electronic Mail
 
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites http://www.cheapcigarettes.com and http://www.cheapcheapsmokes.com and determined that the cigarette and cigarette tobacco and/or roll-your-own tobacco 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, 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 the website http://www.cheapcigarettes.com offers for sale or distributes cigarette tobacco and/or roll-your-own tobacco products. Section 900(4) of the FD&C Act (21 U.S.C. § 387(4)) defines “cigarette tobacco” as “any product that consists of loose tobacco that is intended for use by consumers in a cigarette.” Section 900(15) of the FD&C Act (21 U.S.C. § 387(15)) defines “roll-your-own tobacco” as “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.” 
 
We note that on the website you present a loose tobacco product containing the package description “Hand Rolling Tobacco,” that is offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, Golden Virginia Hand Rolling Tobacco. The overall presentation of this product on the website strongly suggests that it is intended for use in a cigarette, likely to be offered to consumers for making cigarettes, and/or likely to be purchased by consumers for making cigarettes. Specifically, the product description states that the loose tobacco is “perfect for smokers who like their hand-rolled cigarettes,” the product is described as “Cigarette Tobacco,” and the product is listed under the “Tobacco” category of the website. Therefore, the product meets the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined that several cigarette and 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. 
 
Modified Risk Tobacco Product Violations
 
Our review of the websites http://www.cheapcigarettes.com and http://www.cheapcheapsmokes.com  revealed that you sell or distribute cigarette products, which arelisted or described as being “Lights,” “Mild,” or using similar descriptors, for example: American Legend (“American Legend White (Lights) KS Box”), “Camel Mild Orange KS Box,” Davidoff (“Davidoff Gold Filter KS Box,” described as “light,” “medium-light,” and “mild”), Gauloises Filter (“Gauloises Blondes Blue,” described as light), Gitanes (“Gitanes Brunes No Filter,” described as light), Kent (“Kent HD Blue,” described as “light,” “lightest,” and “mild”), King (“King Blue Lights KS Box”), Lucky Strike (“Lucky Strike Blue Lights KS Box”), Pall Mall (“Pall Mall Blue Lights KS Box”), Silk Cut (“Silk Cut Ultra Silver KS Box,” described as “light”), and Vogue (“Vogue Blue Superslims 100’s,” described as medium-light). On the website http://www.cheapcigarettes.com, you also sell or distribute the following cigarette product: Corsair (“Corsair Blue Lights 100s Box”). Additionally, on the website http://www.cheapcigarettes.com, you sell or distribute the following cigarette tobacco and/or roll-your-own tobacco product: Golden Virginia Hand Rolling Tobacco (“Golden Virginia Cigarette Tobacco,” described as “light” and “mild”). 

In addition, you sell or distribute cigarette products that are described as having a reduced level of/exposure to a substance.  Specifically, the website http://www.cheapcigarettes.com includes the following claims: Kent HD Blue KS and Silk Cut Ultra Silver KS Box, described as “low in nicotine” and “low tar”; Kent HD Blue KS, described as having a “small amount of nicotine”; Kent KS Box, described as having “a specially designed charcoal filter to minimize the inhalation of impurities”; Kent Nanotek Infinia, described as having a “filter [that] reduces the amount of tar and nicotine”; Silk Cut Purple Box KS, described as being “lower tar”; and Silk Cut Ultra Silver KS Box, described has having a “patented Silk Cut filter . . . lowering nicotine levels.” The website http://www.cheapcheapsmokes.com includes the following claims: Kent HD Blue KS, described as having a “small amount of nicotine,” “low in nicotine,” and “low-tar;” Kent KS Box, described as having “a specially designed charcoal filter to minimize the inhalation of impurities”; Kent Nanotek Infinia, described as having a “filter [that] reduces the amount of tar and nicotine”; Silk Cut Purple KS Box, described as having “low tar”; and Silk Cut Ultra Silver KS Box, described as “low in nicotine,” “low tar,” and having a “patented Silk Cut filter . . . lowering nicotine levels.” 
 
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 the websites use the descriptors “Lights,” “Mild,” or similar descriptors to describe these products or describe them as containing a reduced level of a substance. 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)).
 
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 these websites, 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, RW1500410, 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
 
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