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  5. Alexander Carter - 05/01/2015
  1. Warning Letters

WARNING LETTER

Alexander Carter


Delivery Method:
Electronic Mail

Recipient:
Alexander Carter


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 

 

MAY 1, 2015 

VIA Electronic Mail
 
Alexander Carter                                                                       
cigdns@gmail.com
 
 
WARNING LETTER
 
Dear Mr. Carter:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites, http://www.cigarena.com, http://www.cigshop.net, http://www.cigarettesfor.us, http://www.cigarettesforsales.com, http://www.discountcigarettesbox.com, http://www.online-cigarettes-shop.com, http://www.discountcigarettesmall.com, http://www.cigarettes-shop.us, http://www.cigarettesmax.com and http://www.best-buy-cigarettes.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 your Camel Filters cigarettes from http://www.cigarettes-shop.com and your American Legend cigarettes from http://www.discountcigarettesmall.com are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold these products to a person younger than 18 years of age.  Additionally, 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. Finally, 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. 
 
Sales to Minors Violation
 
FDA’s investigation of the websites, http://www.cigarettes-shop.com and http://www.discountcigarettesmall.com revealed that you sold cigarette products to a minor. Specifically, during our investigation of these websites, a person younger than 18 years of age purchased Camel Filters cigarettes from the website, http://www.cigarettes-shop.com and American Legend cigarettes from the website, http://www.discountcigarettesmall.com. No retailer may sell cigarettes, cigarette tobacco and/or roll-your-own tobacco, or smokeless tobacco to a person younger than 18 years of age under 21 C.F.R. § 1140.14(a).  Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140.  Because these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(a), these products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
 
Modified Risk Tobacco Product Violations
 
Additionally, our review of the websites, http://www.cigarena.com, http://www.cigshop.net, http://www.cigarettesfor.us, http://www.cigarettesforsales.com, http://www.discountcigarettesbox.com, http://www.online-cigarettes-shop.com, http://www.discountcigarettesmall.com, http://www.cigarettes-shop.us, http://www.cigarettesmax.com and http://www.best-buy-cigarettes.com, revealed that you sell or distribute products listed or described in product labeling or advertising as being “light” or “mild” or using similar descriptors, including, for example::
  • Armada Blue (“Lighter”)
  • Beratt (“light”)
  • Blood Blue (“lighter”)
  • Chesterfield (“light,” “lightest,” “mild,” and “mildness”)
  • Classic (“milder” and “lightest”)
  • Doina Lux Premium (“Lighter”)
  • Donskoy Tabak Lights
  • Esse (lighs) (sic)
  • Glamour Superslims Amber (“light”)
  • Golden Gate Blue (“lighter”)
  • Harpy 4 (“lightest”)
  • Hilton Silver (“the Lights are in a brilliant Silver one.”)
  • L&M Blue Label (“L&M Lights are now L&M Blue Label”)
  • LD Blue (“milder”)
  • Marlboro Silver Super Light
  • Monte Carlo Blue (“lighter”)
  • OK Slims Blue (“mild”)
  • President Special (“lighter”)
  • Prima Lux Gold (“lighter”)
  • Red & White Shine Super Slims (“lighter”)
  • Style Selection Rose Superslims 100’s (“lighter”)
  • Titan Piano (“lightest”)
  • Vogue brand cigarettes (“light”)
  • West Silver (“formerly under west Light”) (sic)
  • Wont Silver (“lightest”)
 
In addition, you sell or distribute cigarette products that are described in product labeling or advertising as presenting a lower risk of tobacco-related disease, being less harmful than one or more other commercially marketed tobacco products, or having a reduced level of/exposure to a substance. Specifically, you offer for sale the following products: 
  • Beratt brand cigarettes, described as “use of modern technology materials and equipment, as well as an effective filter system in the design of cigarettes BERATT, consisting of a ventilated composite triple acetate filter with activated carbon - Triple Acetat + Coal Filter” - ensure that the complex European level of quality and a wide range of light moderate strength and low rates of noxious substances in cigarette smoke”, which decrease in a linear sequence from BERATT XXL to BERATT L” (sic).
  • Cigaronne brand cigarettes, described as “Less nicotine content.”
  • Esse brand cigarettes, described as “low and ultra-low tar.”
  • Kent brand cigarettes, described as “You’ll realize that your lung condition will be out of any danger.”
  • Plai brand cigarettes, described as “contain no harmful substances.”
  • Vogue brand cigarettes, described as “small amount of tar and 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 websites use the descriptors “light,” “mild,” “super lights,” “mildness,” or similar descriptors, and claims of presenting a lower risk of tobacco-related disease, being less harmful than one or more other commercially marketed cigarette products, or having a reduced level of/exposure to 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 the websites, http://www.cigarena.com, http://www.cigarettesfor.us, http://www.cigarettesforsales.com, http://www.discountcigarettesbox.com, http://www.online-cigarettes-shop.com, http://www.discountcigarettesmall.com, http://www.cigarettes-shop.us, http://www.cigarettesmax.com and http://www.best-buy-cigarettes.com, revealed that you offer for sale the following cigarette products: Aroma Rich Apple, Aroma Rich Rum & Cherry, Esse Aura Green Apple, Esse Aura Pink Strawberry, Kiss Fresh Apple Superslims, Kiss Strawberry Superslims, Kiss Mohito, Richmond Cherry, Richmond Cherry Gold, and Richmond Superslim Cherry.
 
These products 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.
 
Cigarette products 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, cherry, mojito, rum & cherry, 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 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, RW1500279, 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:

Alexander Carter
vrotari@gmail.com
 
support@cigarena.com
 
support@cigshop.net
 
support@cigarettesfor.us
 
support@discountcigarettesbox.com   
 
support@online-cigarettes-shop.com
 
support@discountcigarettesmall.com
 
support@cigarettes-shop.us
 
support@cigarettesmax.com
 
support@best-buy-cigarettes.com

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abuse@key-systems.net

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Reg.Ru Network Operations
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