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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.directnetpartners.com 4/10/13

  

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

Public Health Service
Food and Drug Administration
 Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229

APR 10, 2013

VIA Electronic Mail
 
Victoria Allen
Affiliate & Partnership Manager, CPA Affiliate Network
Direct Net Partners
victoria@directnetpartners.com 
affiliates@directnetpartners.com                       
maria@directnetpartners.com
 
 
WARNING LETTER
 
Dear Ms. Allen:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites http://www.airportcigarettes.com, http://www.best-cigs.com, http://www.buycigarette-online.com, http://www.buycigarettesnow.com, http://www.cheapcigarettesclub.net, http://www.cheapcigsclub.com, http://www.cigsvipclub.com, http://www.discountcigarettes24.org, http://www.dutyfree-on.com, http://www.dutyfree-tobacco.com, http://www.onlinesmokeclub.com, http://www.premium-cigarettes.net, and http://www.taxfreesales.net, all affiliates of http://www.directnetpartners.com, and determined that the cigarette products listed there are offered for sale to customers in the United States. FDA believes these websites are affiliated with Direct Net Partners because each website contains an “Affiliates” link to your website, http://www.directnetpartners.com. According to your website, Direct Net Partners recruits and pays affiliates to advertise and obtain orders from customers to purchase your tobacco products. In addition, Direct Net Partners provides affiliates with information about your tobacco products, pricing information, promotional tools, templates, support for affiliates and customers, and shipment of products to customers. Direct Net Partners also offers “Tax-free prices on ALL products plus FREE worldwide shipping.” Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, the products listed on these websites 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 the products listed on your affiliate websites are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are promoted as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that several of the products listed on your affiliate websites 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)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Modified Risk Tobacco Product Violations
 
The products that are promoted for sale on your affiliate websiteshttp://www.airportcigarettes.com, http://www.best-cigs.com, http://www.buycigarette-online.com, http://www.buycigarettesnow.com, http://www.cheapcigarettesclub.net, http://www.cheapcigsclub.com, http://www.cigsvipclub.com, http://www.discountcigarettes24.org, http://www.dutyfree-on.com, http://www.dutyfree-tobacco.com, http://www.onlinesmokeclub.com, http://www.premium-cigarettes.net, andhttp://www.taxfreesales.as being light, ultra light, and mild in the product labeling or advertising. For example, our review of http://www.airportcigarettes.com revealed products listed and described as: American Legend White (“medium-light strength cigarette”), Armada Blue (“reliably mild, these cigarettes are surprisingly refreshing”), Beratt L (“an extraordinarily light cigarette”), Berkeley Blue Superkings (“medium-light strength smoke”), Classic Imperial Blue Slims (“Classic Imperial Blue (Lights)”), Davidoff Blue Slims (“The smooth, mild flavor of these cigarettes make them are a strong choice for any light cigarette smoker.”), Davidoff Blue (“mild cigarette,” “mild smoke,” “different from all other light cigarettes”), Davidoff Gold Slims 100’s (“light cigarette,” “light cigarettes”), Davidoff Gold Slims (“mild yet flavorful blend,” “medium-light cigarettes,” “light cigarettes”), Davidoff Gold Superslims (“light cigarettes”), Davidoff Gold (“light cigarette,” “medium-light blend”), Davidoff Magnum Gold (“light cigarette”), Davidoff White (“light cigarette”), Dunhill Blonde Blend (“mild smoke,” “mild cigarette”), Dunhill Fine Cut Silver (“light blend”), Esse Super Slims Field (“ultra-light cigarette,” “light enjoyable cigarette”), Fortuna Blue (“light cigarettes”), G.B. Silver (“light cigarette,” “light cigarettes”), Gauloises Blondes Blue (“light, American-style tobacco”), Gauloises Blondes Yellow (“cigarettes are light and refined,” “ultra-light cigarettes,” “these ultra lights”), Glamour Amber Superslims (“light cigarettes”), Glamour Azure Superslims (“light cigarettes”), Glamour Blossom Aroma Superslims (“light cigarettes”), Glamour Lilac Superslims ( “medium-light cigarettes,” “flavorful yet mild smoke”), Glamour Menthol Superslims (“With only 0.3mg of nicotine in each stick, these cigarettes are light enough for regular smoking”), Golden Gate Blue (“light cigarette”), Karelia Ome Menthol (“light cigarettes”), Karelia Ome Yellow (“light cigarette”), Kent Blue Futura (“light smoke,” “mild cigarettes”), Kent HD Infina (“mild cigarette”), Kent Nanotek Futura (“medium-light strength cigarette”), Lambert & Butler Gold (“light smokes,” “light cigarette”), Marengo Piano (“light cigarette”), Monte Carlo Fantasy Super Slims (“light cigarette,” “mild smokes”), Monte Carlo Intrigue Super Slims (“ultra-light cigarette”), Monte Carlo Silver (“light cigarette”), Monte Carlo White (“ultra-light smoke”), Nat Sherman Naturals Yellow (“light cigarette”), Pall Mall Nanokings Amber (“light cigarette”), Prince Rounded Taste (“Formerly known as Prince Lights, these mild yet flavorful cigarettes”), R1Blue (“mild cigarette”), R1 Slim Line 100’s (“mild, slim cigarette”), R1 Slim Line (“mild smokes”), Silk Cut Purple 100’s (“ultra-light”), Silk Cut Purple (“light smoke,” “light cigarette”), Silk Cut Silver (“flavor that distinguishes it from most other light cigarette brands”), Silk Cut (“a light brand” “light cigarette”), Vogue Blue Superslims (“medium-light cigarettes”), Vogue Lilas Superslims (“light cigarettes”), Winston Blue Super Slims (“light cigarette,” “lighter smoke”), Winston White (“very low in tar and nicotine volumes-- the characteristics of the former ‘Ultra Lights’ cigarettes”), Winston XS Blue (“milder cigarette,” “light product”), Winston XS Silver (“light cigarettes”), and Wont Silver (“The classic light smoke”) cigarettes.
 
Similarly, products, including but not limited to those listed below, are promoted for sale on the following websites:
 
  • http://www.best-cigs.com: Davidoff Blue Slims (“light cigarette,”)
  • http://www.buycigarette-online.com: Silk Cut (“light brand,” “light smoking experience”)
  • http://www.buycigarettes.now.com: American Legend White (“medium-light strength”)
  • http://www.cheapcigarettesclub.net: Dunhill Fine Cut Silver (“light blend”)
  • http://www.cheapcigsclub.com: Karelia Ome Yellow (“light cigarette”)
  • http://www.cigsvipclub.com: Monte Carlo Silver (“light cigarette”)
  • http://www.discountcigarettes24.org: Kent Blue Futura (“premium light smoke,” “mild cigarettes”)
  • http://www.dutyfree-on.com: Glamour Azure Superslims (“light cigarettes”)
  • http://www.dutyfree-tobacco.com: Silk Cut Purple (“light smoke,” “light cigarette”)
  • http://www.onlinesmokeclub.com: Vogue Lilas Superslims (“light cigarettes”)
  • http://www.premium-cigarettes.net: Winston White (“Ultra Lights”)
  • http://www.taxfreesales.net: Karelia Slims Party (“mild”)
 
In addition, the products promoted for sale on your affiliate websites are described as containing a reduced level of a substance or presenting a reduced exposure to a substance. For example, the following products were described on http://www.airporticgarettes.com:
 
  • Davidoff Blue Slims (“low in nicotine content”),
  • Davidoff Blue (“low on nicotine content”),
  • Dunhill Fine Cut Silver (“low nicotine smoke”),
  • Esse Super Slims Blue (“low tar count and light levels of nicotine”),
  • Gauloises Blondes Red (“low-tar cigarettes”),
  • Gauloises Blondes Yellow (“low-tar,” “filter helps remove unwanted tar”),
  • Karelia Menthol Slims (“light in both nicotine and tar”),
  • Kent Blue 100’s (“Kent cigarettes were the first brand to start using a filter to significantly reduce the amount of tar and nicotine that smokers were exposed to”),
  • Kent Blue Futura (“Kent have been regarded as the cigarette to turn to when you want less tar and nicotine”),
  • Kent HD Infina (“low in nicotine,” “low-tar and contains only a small amount of nicotine”),
  • Monte Carlo White (“low level of nicotine”),
  • Raquel Slims Menthol (“low tar and nicotine”),
  • Silk Cut Purple (“low nicotine cigarettes”),
  • Silk Cut Silver (“low in nicotine and have a low tar content”),
  • Silk Cut (“low nicotine, low tar”, “lower tar and nicotine”),
  • Winston White (“very low in tar and nicotine volumes,” “despite their low tar and nicotine levels”), and
  • Winston XS Nano Silver (“a lower dosage of nicotine and tar than their full flavor counterpart”).
 
Similarly, products, including but not limited to those listed below, are promoted for sale on the following websites:
 
  • http://www.best-cigs.com: Davidoff Blue Slims (“low in nicotine”),
  • http://www.buycigarette-online.com: Silk Cut (“low nicotine, low tar smoke,” “lower tar and nicotine”),
  • http://www.buycigarettesnow.com: Karelia Menthol Slims (“light in both nicotine and tar”),
  • http://www.cheapcigarettesclub.net: Winston XS Nano Silver (“a lower dosage of nicotine and tar than their full flavor counterpart”),
  • http://www.cheapcigsclub.com: Raquel Slims Menthol (“low tar and nicotine”),
  • http://www.cigsvipclub.com: Dunhill Fine Cut Silver (“low nicotine”),
  • http://www.discountcigarettes24.org: Kent Blue Futura  (“less tar and nicotine”),
  • http://www.dutyfree-on.com: Gauloises Blondes Yellow (“filter helps remove unwanted tar”),
  • http://www.dutyfree-tobacco.com: Rothmans Red Special Mild (“the cigarette’s cellulose filter traps extra tar”),
  • http://www.onlinesmokeclub.com: Silk Cut Silver (“low in nicotine and have a low tar content”),
  • http://premium-cigarettes.net: Winston White (“very low in tar and nicotine volumes,” “despite their low tar and nicotine levels”), and
  • http://www.taxfreesales.net: Silk Cut Purple (“low 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) such product or its smoke contains a reduced level of a substance, 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 usethe descriptors “Light,” “Ultra Light” and “Mild” or similar descriptors for the above listed products, these products are modified risk tobacco products. Because these products are offered for sale 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 http://www.airportcigarettes.com revealed the following cigarettes promoted for sale: “Aroma Rich Apple,” “Aroma Rich Rum & Cherry,” “Kiss Fresh Apple Superslims,” “Kiss Strawberry Superslims,” “Lady Rose Slims,” “Richmond Cherry Gold,” and “Richmond Cherry”, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Similarly, cigarettes, including but not limited to those listed below, are promoted for sale on the following websites: Aroma Rich Apple (http://www.best-cigs.com, http://www.cigsvipclub.com, http://www.discountcigarettes24.org, and http://www.onlinesmokeclub.com), Aroma Rich Rum & Cherry (http://www.buycigarette-online.com, http://www.cheapcigarettesclub.com, and http://www.taxfreesales.net), and Kiss Fresh Apple Superslims (http://www.buycigarettesnow.com, http://www.cheapcigsclub.com, http://www.dutyfree-on.com, http://www.dutyfree-tobacco.com, and http://www.premium-cigarettes.net). 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 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, the flavored cigarettes on your affiliate websites are adulterated.
 
If, however, these cigarettes 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 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false and misleading because it makes the representation that the products contain, for example, apple, rum & cherry, cherry, strawberry, or rose, as 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 these websites, or any other websites or 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 importation 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, RW1300064, in your response and direct your response to the following address:
 
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850 
 
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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cc:
 
Moniker Privacy Services
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http://www.best-cigs.com
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http://www.dutyfree-on.com
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Jason Mercer c/o Dynadot Privacy
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