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WARNING LETTER

http://www.buy-cigarettesonline.com/ 16/09/2014

http://www.buy-cigarettesonline.com/ - 09/16/2014


Delivery Method:
Electronic Mail

Recipient:
Recipient Name
Viktor Grin
http://www.buy-cigarettesonline.com/


United States

Issuing Office:
Center for Tobacco Products

United States


  

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

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

SEPT 16, 2014

VIA Electronic Mail
 
Viktor Grin                               
 
 
WARNING LETTER
 
Dear Mr. Grin:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.buy-cigarettesonline.com, and determined that 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 (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 the website, http://www.buy-cigarettesonline.com, as “light” or “ultra light” by referring to them as such in product labeling or advertising or adding the qualifiers to product names. Specifically, the website sells or distributes the following cigarettes described as “Lights Cigarettes,” including but not limited to: “Bond Special Selection,” “Camel Black Super Slims 100s,” “Camel Blue,” “Chesterfield Classic Blue,” “Davidoff Gold,” “Dunhill Fine Cut Dark Blue,” “Kent Blue Futura Nr. 8,” “Kiss Dessert(mini),” “Lucky Strike Original Silver,” “Marlboro Gold,” “Parliament Aqua Blue,” “Richmond Klan,” “Sobranie Blue,” “West Black Compact,” “Magna Balanced Blue,” “More Balanced Blue,” “Pall Mall Blue,” and “Viceroy Blue.” The website also offers for sale Pall Mall Blue cigarettes described as “Pall Mall Lights (Blue).”  Additionally, the website sells or distributes the following cigarettes described as “Ultra Lights Cigarettes,”  including but not limited to: “Bond Fine Selection,” “Bond Special Compacts,” “Camel Black mini,” “Camel Silver,” “Camel White Super Slims 100s,” “Chesterfield Classic Bronze,” “Davidoff Blue,” “Dunhill Fine Cut Azure,” “Kent HDs Silver Super Slims 100s,” “Kent Silver Neo Nr. 4,” “L&M Motion Blue(mini),” “Parliament Carat Blue,” “Parliament Silver Blue,” “Richmond Cherry 4,” “Richmond Masculine Super Slims 100s,” “Vogue Super Slims Lilas 100’s,” “West Fusion White,” “Winston XSence Silver(mini),” “Marlboro Gold Prime Edge 100s,” “More Subtle Silver,” “Pall Mall Azure,” and “Viceroy Silver.”
 
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)). 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 descriptors “light,” “ultra light,” or similar descriptors 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 your website,revealed that you offer for sale the following cigarette products: “Aroma Rich Apple,” “Aroma Rich Rum Cherry,” “Richmond Cherry Gold Super Slims 100s,” “Richmond Cherry 4,” “Richmond Cherry,” “Richmond Cherry Super Slims 100s,” “Kiss Mohito(mini)” (sic), “Kiss Super Slims Clubnichka 100s” (strawberry), and “Kiss Super Slims Fresh Apple 100s,” 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.
 
These requirements apply to cigarettes and cigarette tobacco, which includes roll-your-own tobacco and any other loose tobacco intended to be used in cigarettes or as roll-your-own tobacco. See sections 900(3), 900(4), 907(a)(1)(A) of the FD&C Act; (21 U.S.C. § 387(3); 21 U.S.C. § 387(4); 21 U.S.C. § 387g(a)(1)(A)). 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, apple, rum cherry, 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 sell or 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, RW1400215, in your response and direct your response to the following address:
 
DPAL-WL Response, Office of Compliance and Enforcement
Food and Drug Administration
Center for Tobacco Products
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
 
VIAElectronic Mail
 
cc:
 
Viktor Grin
 
Domain.com, LLC
 
The Endurance International Group, Inc.
 
Eric White
iPage Hosting
 

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