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U.S. Department of Health and Human Services

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Enforcement Actions

Edelveis Enterprises Limited 1/4/13

  

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

JAN 4, 2013

VIA Electronic Mail
 
Dmitrii Strusovschii                  
Edelveis Enterprises Limited
dima@c2.ru                             
 
 
WARNING LETTER
 
Dear Mr. Strusovschii:
 
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your websites, http://www.buy-cigarettes-online.net, http://www.cigarette-shop.org, http://www.eurocheapcigarettes.com, http://www.cigarette-store.net, http://www.discount-cigarettes-store.net, and http://www.cheapcigarette.org, and determined that your cigarette products listed there are offered for sale to customers in the United States. FDA believes these websites are affiliated with one another because http://www.buy-cigarettes-online.net, http://www.cigarette-shop.org, http://www.eurocheapcigarettes.com, http://www.discount-cigarettes-store.net, and http://www.cigarette-store.net list Edelveis Enterprises Limited either as their managing company or registrant, and http://www.eurocheapcigarettes.com, http://www.cigarette-store.net, and http://www.discount-cigarettes-store.net redirect to http://www.cheapcigarette.org to complete a purchase. 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 several of your 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)). 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, http://www.buy-cigarettes-online.net, http://www.cigarette-shop.org, http://www.eurocheapcigarettes.com, http://www.cigarette-store.net, and http://www.cheapcigarette.org as being light, super light, premium light, and ultra light by referring to them as such in product advertising and adding the qualifiers “Lights,” “Super Lights,” “Ultra Lights” and “Premium Lights,” to the product names. Specifically, our review of your websites revealed that you offer for sale cigarettes listed as: “Kent White Infina N1 (Lights),” “Kent Silver Neo N4 (Super Lights),” and “Kent Blue Futura N8 (Premium Lights)” on the websites http://www.buy-cigarettes-online.net, http://www.cigarette-shop.org, and http://www.cheapcigarette.org; “More Balanced Blue (Lights)” on the websites http://www.buy-cigarettes-online.net and http://www.cigarette-shop.org; “Winston Super Slims Blue (Lights)” on the website http://www.cigarette-shop.org; “Pall Mall Amber (Ultra Lights)” and “Pall Mall Blue (Lights)” on the websites http://www.cigarette-shop.org and http://www.cheapcigarette.org; “Lucky Strike Original Silver (Lights)” on the websites http://www.eurocheapcigarette.com and http://www.cheapcigarette.org; and Epique Superslims Menthol 100s (“Epique Superslims Menthol Lights 100s”) on the website http://www.cheapcigarette.org. Your websites http://www.cigarette-shop.org, http://www.eurocheapcigarettes.com, http://www.cigarette-store.net, and http://www.cheapcigarette.org display the following description for Kent cigarettes: “Kent cigarettes are still positioned as mild and easy cigarettes to smoke. It is now prohibited to state that they are somewhat safer or less harmful than other cigarettes, but the connotation is the same: Wanna be safe ? choose Kent” (sic). Your website http://www.cheapcigarette.org displays the following description for Epique cigarettes: “This new slim line of cigarette is great tasting yet provides less harmful chemicals than a full flavor cigarette.”
 
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 websites use the descriptors “Lights,” “Super Lights,” “Premium Lights,” “Ultra Lights,” 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)).
 
Additionally, our review of your websites revealed that you offer for sale the following cigarettes: Lady Rose on http://www.cigarette-shop.org, http://www.eurocheapcigarettes.com, http://www.cigarette-store.net, and http://www.cheapcigarette.org; Kiss Fresh Apple Superslims on http://www.cigarette-shop.org, http://www.eurocheapcigarettes.com, http://www.cigarette-store.net, http://www.discount-cigarettes-store.net, and http://www.cheapcigarette.org; and Sobranie Mints on http://www.cheapcigarette.org, 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 rose, apple, or mint, or 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, RW1200049, 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 Elenita.IbarraPratt@fda.hhs.gov.   
 
 
Sincerely,
/S/
 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
 
cc:
 
support@cigarette-shop.org
cigarette-shop.org@domainsbyproxy.com
 
support@eurocheapcigarettes.com
eurocheapcigarettes.com@domainsbyproxy.com
 
support@cigarette-store.net
cigarette-store.net@domainsbyproxy.com
 
support@cheapcigarette.org
cheapcigarette.org@domainsbyproxy.net