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  5. www.hqcigarettes.com - 03/23/2015
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WARNING LETTER

www.hqcigarettes.com Mar 23, 2015

www.hqcigarettes.com - 03/23/2015


Delivery Method:
UPS & Electronic Mail

Recipient:
Recipient Name
George Walker
www.hqcigarettes.com

302 E. 12th St.

New York City, NY 10012
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 

 

 

MAR 23, 2015

 
VIA UPS & Electronic Mail
 
George Walker
302 E. 12th St.
New York City, NY 10012
GeorgeWalker@hotmail.com
 
 
WARNING LETTER
 
Dear Mr. Walker:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website http://www.hqcigarettes.com, and determined that your cigarette products listed there are offered for sale or distributed 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 of your cigarette 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 products that you describe on your website http://www.hqcigarettes.com, as being light or ultra light by referring to them as such in product labeling or advertising and adding the qualifiers “Lights” or “Ultra Lights” to the product names.  Specifically, our review of the website revealed that you sell or distribute cigarette products listed under the heading “LIGHTS CIGARETTES,” including, but not limited to: Bond Special Selection, Camel Black Super Slims 100’s, Camel Blue, Chesterfield Classic Blue, Davidoff Gold, Dunhill Fine Cut Dark Blue, Kent Blue Futura Nr. 8, Kent HDi Blue, Kent HDs Blue Super Slims 100s, Kiss Dessert (mini), Kiss Mohito (mini), Lucky Strike Original Silver, Marlboro Gold, Parliament Aqua Blue, Sobranie Blue, Sobranie Classic Silver, Sobranie White Russian, West Black Compact, Winston Blue, Winston Super Slims Blue 100’s, Winston XSence Blue (mini), Magna Balanced Blue, More Balanced Blue, Pall Mall Blue, Richmond Cherry Gold Super Slims 100s, Richmond Cherry Super Slims 100s, Richmond Klan, and Viceroy Blue. Additionally, the website sells Pall Mall King Size Box cigarettes described as “Pall Mall Lights (Blue),” and Virginia Cigarettes described as “Virginia cigarettes tobacco is very light and mild.”  
 
Our review of the website also revealed that you sell or distribute the following cigarette products under the heading “ULTRA LIGHTS CIGARETTES,” including, but not limited to: Bond Fine Selection, Bond Special Compacts, Camel Black mini, Camel Silver, Camel White Super Slims 100’s, Chesterfield Classic Bronze, Davidoff Blue, Dunhill Fine Cut Azure, Kent HDi Silver, Kent HDs Silver Super Slims 100’s, Kent Silver Neo Nr. 4, L&M Motion Blue (mini), L&M Motion Silver (mini), L&M Silver Label, Parliament Carat Blue, Parliament Silver Blue, Sobranie Gold, Vogue Super Slims Lilas 100’s, West Fusion White, Winston Silver, Winston XSence Silver (mini), Marlboro Gold Prime Edge 100’s, Marlboro Silver, More Subtle Silver, Pall Mall Azure, Richmond Cherry 4, Richmond Masculine Super Slims 100’s, Richmond Platinum Filter, and Viceroy Silver.
 
You also offer for sale or distribute cigarette products on your website described as containing a reduced level of a substance, reduced exposure to a substance or reduced harm. Specifically, you offer for sale the following products: 
  • Kent Light Cigarettes described as “Kent Light with a minimum amount of tar and nicotine”
  • Parliament Cigarettes described as “Parliament cigarettes nicotine content is not too high”
  • Virginia Cigarettes described as “contains a reduced amount of nicotine.”
 
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 descriptor “Lights” or “Ultra Lights,” or similar descriptors for the above listed products, or claims that the products contain a reduced level of a substance, 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 your website www.hqcigarettes.com, revealed that you offer for sale the following cigarette products: “Kiss Mohito (mini),” “Kiss Super Slims Clubnichka 100s” (strawberry image), “Kiss Super Slims Fresh Apple 100s,” “Richmond Cherry Gold Super Slims 100s,” “Richmond Cherry Super Slims 100s,” “Richmond Cherry 4,” and “Richmond Cherry,” 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 donot 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, cherry, mojito, or strawberry 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 promotional materials 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, RW1500269, 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:
 
Center of Ukrainian Internet Names (UKRNames)
abuse@ukrnames.com
 
 
Neil Young
3NT Solutions LLP
info@3nt.com

 

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