Alex Freeman 11/1/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
VIA UPS and Electronic Mail
Testimitianu 13/2, apt. 45
Dear Mr. Freeman:
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your websites http://www.camel-cigarettes.net, http://www.cigarettesmall.net, http://www.hot-cigs.com, http://www.cigarettesworld.com, http://www.cigs4us.com, http://www.ourcigarettes.net, http://www.salecigarettesonline.com, http://shop-cigarette.com, http://www.shop-smoke.com, http://www.topcigarettesonline.com, http://us-cigs.com, http://verycheapcigarettes.com, http://www.best-tobacco.com, http://cigarettesplace.net, and http://www.cigarette-store.org and determined that your cigarette products listed there are offered for sale to U.S. customers. FDA believes these websites are affiliated with one another because they are all registered to you, and they all redirect to the same website (http://www.pay-cigs.com) during the purchase and checkout process. 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, 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 products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that your products “Kiss Super Slims Fresh Apple,” “Kiss Super Slims Strawberry,” “Richmond Cherry,” “Richmond Cherry Gold,” “Rich Apple,” and “Rich Rum & Cherry” 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)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
You describe products that you offer for sale on your websites as being mild, light, ultra light, and super light by referring to them as such in product advertising and adding the qualifiers “Lights,” “Ultra Lights,” and “Super Lights,” to the product names. Specifically, our review of your website http:/www.camel-cigarettes.net revealed that you offer for sale the following cigarettes:“Camel Blue (Lights),” and “Camel Silver (Super Lights).” Our review of your websites http://cigarettesplace.net, http://www.best-tobacco.com and http://www.shop-smoke.com also revealed that you offer for sale the following cigarette: “Esse Lights (blue color).” In addition, our review of your website http://verycheapcigarettes.com revealed that you sell the following cigarettes: “Marlboro Gold – former Marlboro Lights …,” and “Marlboro Silver – former Marlboro Ultra Lights ….” Further, your website http://www.hot-cigs.com offered for sale “Red & White Special” and “Red & White Fine” which, as described on the site, “…would suit those who like more mild smoke;” and your website http://www.shop-cigarette.com offers for sale R1 brand cigarettes which, as described on the site, is “…the leading brand in the ultra light segment.”
In addition, your websites include claims that the products or their smoke contain a reduced level of a substance or present a reduced exposure to a substance, or that the products are less harmful than other commercially marketed tobacco products. Such promotions include, but are not limited to, the following statements:
- “… there is one more reason to select Camel Blue – the reduced amount of nicotine and tar.” (http://www.camel-cigarettes.net)
- “With Camel Silver cigarettes you can enjoy the ravishing taste and fascinating aroma of these cigarettes without worrying about your health since they provide the lowest ever rate of harmful additives, tar and nicotine.” (http://www.camel-cigarettes.net)
- “Parliament cigarettes differ from other brands by their unique recessed paper filters in comparison to the solid foam filter used in other tobacco products with filters. This filter not only makes these fags more environmentally safe as the paper is better than the foam but they are also healthier for smokers.” (http://www.cigarettesmall.net)
- “Along with its superb quality and taste features, Parliament cig brand provides the cigarette smokers with another unique and vital characteristic – the most effective and advanced filter system across cigarette industry. The recessed filter technology cools the cigarette smoke, contributing to a safer smoking experience.” (http://www.hot-cigs.com)
- “Esse Super Slim (low tar cigarettes).” (http://www.cigs4us.com)
- “A “Triple Acetat+Coal Filter” assures a European Quality Standard and a wide range of light moderate strength and low indicator of harmful substances in cigarette smoke” (regarding Beratt cigarettes, at http://www.cigs4us.com).
- “Usage of the high-tech technologies in the production of this brand, as well as application of advanced filter system, containing acetate and coal filter, which in combination guarantee high level of quality and low quantity of dangerous substances in tobacco smoke, as well as broad assortment of styles which range by strength” (regarding Beratt cigarettes, at http://www.ourcigarettes.net).
- “… R1, a cigarette that makes it easy to choose low tar and nicotine yields without compromising full smoking pleasure.” (http://www.shop-cigarette.com)
- “The producer of Style cigarettes - the 'Reemesma Tobacco factory GMBh is best-known for its researches in the field of preventing the exposure to nicotine and additives, and the experts of this manufacturer have succeed in creating unique filter technology which would provide one of the lowest tar and nicotine rates in slim cigarette class.” (http://www.shop-smoke.com)
- “Application of the advanced technologies in the process of manufacture of the cigarettes, and usage of efficient filter systems, based on acetate and coal filter, ensure high quality level and low amounts of harmful chemicals in cigarette smoke” (regarding Beratt cigarettes, at http://www.verycheapcigarettes.com).
- “In addition, namely these cigarettes provide the lowest tar and nicotine level in slims cigarette class. So, don’t worry about your lungs because the only thing that would remain after having smoked Eva cigarettes would be giant pleasure of their gentle yet ravishing taste.” (http://www.best-tobacco.com)
- “The tobacco of this fag is of the highest class. Its … special filter construction will protect your lungs from harmful substances penetration” (regarding Style brand cigarettes, at http://www.cigarette-store.org).
- “Its special filter of chocolate color secures your health from pervasion of any toxic substances” (regarding Luceafăr brand cigarettes, at http://www.cigarette-store.org).
A tobacco product with a label, labeling, or advertising that uses the descriptors “light,” “mild,” or “low,” or similar descriptors 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 the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more commercially marketed tobacco products, or that the tobacco product or its smoke contains a reduced level of a substance, presents a reduced exposure to a substance, or 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 websites use the descriptors “Light,” “Mild,” “Ultra Light,” and “Super Light,” or similar descriptors for the above-listed products and include claims that the products or their smoke contain a reduced level of a substance or present a reduced exposure to a substance, or that the products are less harmful than other commercially marketed tobacco products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers 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 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Additionally,our review of the websites http://www.cigarettesmall.net, http://www.hot-cigs.com, http://www.cigarettesworld.com, http://www.cigs4us.com, http://www.ourcigarettes.net, http://www.salecigarettesonline.com, http://shop-cigarette.com, http://www.shop-smoke.com, http://www.topcigarettesonline.com, http://us-cigs.com, http://verycheapcigarettes.com, http://www.best-tobacco.com, http://cigarettesplace.net, and http://www.cigarette-store.org revealed that on each website, you offer for sale two or more of the following cigarettes: “Kiss Superslims Fresh Apple,” “Kiss Superslims Strawberry,” “Rich Rum and Cherry,” “Richmond Cherry,” and “Richmond Cherry Gold,” which are 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.
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, your flavored cigarettes 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)) as their labeling is false and misleading because it makes the representation that the products contain apple, rum and cherry, cherry, or strawberry as characterizing flavors of the tobacco products.
You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on these websites or any other websites you own, operate, and/or control comply with the applicable provisions of the FD&C Act. 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.
Please note your reference number, RW1200043, 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 via email at Elenita.IbarraPratt@fda.hhs.gov
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
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