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  5. www.guarde.info - 07/08/2015
  1. Compliance Actions and Activities

WARNING LETTER

www.guarde.info Jul 08, 2015

www.guarde.info - 07/08/2015


Delivery Method:
Electronic Mail

Recipient:
www.guarde.info


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 

 

 

JUL 8, 2015
VIA Electronic Mail
 
To: b298b9cbfa4e4a3384fe3daaed2ecbc9.protect@whoisguard.com
 
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website  http://www.guarde.info and determined that your cigarette, 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 (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, 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.guarde.info, offers for sale 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 loose tobacco products that are offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, including Drum Blue Rolling Tobacco, Captain Black White Rolling Tobacco, Old Holborn Yellow Rolling Tobacco, Samson Halfzware Rolling Tobacco, and Van Nelle Halfzware Shag Rolling Tobacco.  The overall presentation of these products on the website strongly suggests that they are 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 website describes the loose tobacco products as “Rolling Tobacco.” Additionally, the webpage for Captain Black White Rolling Tobacco states “ . . . the last cigarette will taste just as great as the first,” the webpage for Old Holborn Yellow Rolling Tobacco states “ . . . perfect for when you just need to have a cigarette,” the webpage for Samson Halfzware Rolling tobacco states, “The tobacco has a medium-shag cut, making it easy to both hand roll and use in injection machines with pre-rolled filter tubes,” and the webpage for Drum Blue Rolling Tobacco is sold with rolling papers and states “ . . . keep the tobacco fresh so the last cigarette is sure to taste as good as the first one.”  Thus, the overall presentation of theseloose tobacco products, suggests that they are intended for use in a cigarette and/or,appear to be suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes. Therefore, they meet the definition of cigarette tobacco and/or roll-your-own tobaccoin the FD&C Act.
 
FDA has determined that several of your 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 and Dunhill Red 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.  
 
Modified Risk Tobacco Product Violations
 
Our review of the website, http://www.guarde.info, revealed that you sell or distribute cigarette products, cigarette tobacco and/or roll-your-own tobacco products listed or described in product labeling or advertising as being “light,” “ultra-light,” or “mild,” or using similar descriptors, for example: Camel White, Davidoff ID Blue, Davidoff Magnum Gold, Davidoff Fine Cut Menthol, Gauloises Blondes Blue, G.B. Silver, Glamour Blossom Aroma Superslims, Glamour Menthol Superslims, Glamour Pink Superlims, Karelia Ome, Karelia Ome Menthol, Karelia Ome Yellow, Kent Nanotek Infina, Kent White Infina, Lambert & Butler Gold, Raquel Slims Menthol, Silk Cut Purple, Silk Cut Silver, Vogue Blue Superslims, and Winston XS Silver, described as “light”; Karelia Slims Party, described as “mild”; Karelia White, described as “mild” and “one of the lightest”; Golden Gate Blue, described as “light” and “milder”; Davidoff Gold and Davidoff Gold Slims, described as “light” and “mild”; Silk Cut Purple 100’s, described as “ultra-light”; Mayfair Sky Blue, described as “lighter”; and BestMan Original Blue 100’s, described as “lighter.” You also sell or distribute Captain Black White Rolling Tobacco, Old Holborn Yellow Rolling Tobacco, and Samson Halfzware Rolling Tobacco, described as “mild”; Drum Blue Rolling Tobacco, described as “light”; and Van Nelle Halfzware Shag Rolling Tobacco, described as a “[t]he ideal balance between rich and mild tobaccos.”
 
In addition, you offer for sale or distribute cigarette products on your website described as containing a reduced level of a substance or reduced exposure to a substance. Specifically, you offer for sale the following products:
  
  • Gauloises Blondes Red (“low tar”),
  • Dunhill Fine Cut Silver and Silk Cut Purple ( “low nicotine”)
  • Karelia Menthol Slims (“Light in both nicotine and tar”),
  • Silk Cut Silver (“low in nicotine and have a low tar content”),
  • Karelia Ome Yellow (“light nicotine”),
  • Raquel Slims Menthol (“low tar and nicotine”),
  • Davidoff ID Blue (“with lower amounts of Tar and Nicotine”),
  • Mayfair Sky Blue (“mild content of both nicotine and tar”),
  • Kent Nanotek Infina (“light Nicotine”),
  • Kent Blue 100’s (“a filter to significantly reduce the amount of tar and nicotine that smokers were exposed to”),
  • Kent Nanotek Neo (“filter removes more tar and nicotine than any other brand, meaning more protection”),
  • Silk Cut Silver (“filter . . . lowering nicotine levels”),
  • Silk Cut Purple 100’s (“filter makes an already mellow cigarette that is much smoother, lowering the nicotine dose” and “won’t leave behind a harsh throat hit”),
  • West Red (“a perfectly balanced filter lets the full-bodied spirit of these cigarettes through while filtering out tar and un-burnt tobacco”)
  • Kent (“charcoal filter to minimize the inhalation of impurities”),
  • Kent Blue 100’s (“[t]he filter used in these cigarettes is meant to reduce the impurities smokers are exposed to”),
  • Dunhill Red (“won’t irritate your throat”), and
  • Camel Blue (“ . . . have a taste that’s not as harsh. The full flavor Camels sometimes feel rough on the throat, but that is never a problem with the Camel Blue cigarettes”).
 
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 your website uses the descriptor “light,” “ultra-light,” “mild,” or similar descriptors for the above listed products or describes products as being less harmful or containing a reduced level of a substance than one or more commercially marketed tobacco 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 the website, http://www.guarde.info, revealed that you offer for sale or distribute the following cigarette product: Dunhill International (plum extract).  This product is purported 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.
 
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 product is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, this 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 itslabeling or advertising is false or misleading because it makes the representation that this product contains plum extract 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 labeling and/or advertising 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Please note your reference number, RW1500325, 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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