Inspections, Compliance, Enforcement, and Criminal Investigations

http://www.premium-smokes.com 2/11/15

  

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 

 

FEB 11, 2015

VIA Electronic Mail
 
 
To: pw-e524dfd5572af3906c582ead0ae2f88d@privacyguardian.org
 
 
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.premium-smokes.com, and determined that your 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 (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 Pall Mall Red cigarettes 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, in violation of 21 C.F.R. § 1140.14(a).  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. Additionally, FDA has determined that your Dunhill International cigarettes 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.
 
Sales to Minors Violation
 
FDA’s investigation of your website, http://www.premium-smokes.com revealed that you sold a cigarette tobacco product to a minor. No retailer may sell cigarettes 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.  A person younger than 18 years of age purchased Pall Mall Red cigarettes from your websiteBecause 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
 
You sell or distribute cigarette products that you describe on the website, http://www.premium-smokes.com, as being “light,” “ultra-light,” “super light,” or “mild,” by referring to them as such in product labeling or advertising. Specifically, our review of the website revealed that you sell or distribute cigarette products with such claims, including, but not limited to:
 
  • American Legend White described as “medium-light”
  • Berkeley Blue Superkings described as “medium-light”
  • BestMan Original Blue 100’s described as “light”
  • Camel Milds Orange
  •  Davidoff Gold described as “light” and “mild”
  •  Dunhill Fine Cut Dark Blue described as “mild”
  •  Fortuna Blue described as “light” and “mild”
  •  Gauloises Blondes Yellow described as “light” and “ultra-light”
  •  Glamour Menthol Superslims described as “light”
  •  Golden Gate Blue described as “light” and “milder”
  •  Karelia Ome described as “light”
  •  Kent White Infina described as “light” and “mild”
  •  Lambert & Butler Gold described as “light”
  •  Nat Sherman Naturals Yellow described as “light”
  •  R1 Blue described as “mild” and “lightest”
  •  Rothmans Red Special Mild
  •  Silk Cut Purple 100s described as “light” and  “ultra-light”
  •  Vogue Lilas Superslims described as “light”
  •  Winston Silver described as “super lights” and “lights”
 
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:
 
  • Berkeley Blue Superkings described as “light in nicotine content”
  • Davidoff ID Blue described as “lower amounts of tar and nicotine”
  • Dunhill Fine Cut Silver described as “low nicotine”
  • Gauloises Blondes Yellow described as “low-tar” and “the cigarette’s cellulose filter helps remove unwanted tar.”
  • Karelia Menthol Slims described as “light in both nicotine and tar”
  • Karelia Ome Yellow described as “light nicotine fix”
  • Kent Nanotek Neo described as “The Kent filter removes more tar and nicotine than any other brand, meaning more protection…”
  • Rothmans Red Special Mild described as “The cigarette's cellulose filter traps extra tar …”
  • Silk Cut Purple described as “low nicotine”
  • Silk Cut Silver described as “low in nicotine and have a low tar content that is made even more impressive by the patented Silk Cut filter.”
  • Silk Cut described as “Silk Cut cigarettes are the low nicotine, low tar smoke” and “Silk Cut cigarettes bring together a perfectly crafted tobacco blend with an aerating filter that lowers nicotine consumption”
  • State Express 555 Mandarin International Pearl described as “lower levels of Nicotine and Tar.”
  • Winston Blue Super Slims described as “lower tar and nicotine levels”
  • Winston Silver described as “Compared to their full-bodied counterparts, these cigarettes contain half as much nicotine and less than half the amount of tar.”
 
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. § 387(8)).  Because your website uses the descriptors “light,” “ultra light,” “super lights,” “mild” or similar descriptors for certain products listed aboveor describes certain products as containing a reduced level of a substance or being less harmful, 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 revealed that you offer for sale the cigarette product, Dunhill International (plum), which ispurported to contain an artificial or natural flavor that is a characterizing flavor of the product. 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.
 
If, however, the cigarette product does not contain a characterizing flavor, it is 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 its labeling or advertising is false or misleading because it makes the representation that the product contain, for example, plum as a characterizing flavor of the tobacco product.
 
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, RW1500257, 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:
 
Namesilo, LLC
abuse@namesilo.com
 
GBServers
abuse@gbclients.co.uk

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