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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229
APR 30, 2013
Via Electronic Mail
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.cigarettes-shop.net, 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 (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)) 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 Violations
You describe products that you offer for sale on the website, http://www.cigarettes-shop.net, as being light by referring to them as such in product labeling or advertising and adding the qualifiers “Lights” or “Super Lights” to the product names. Specifically, our review of the website revealed that you offer for sale the following products listed as: Bond Special Selection described as “Bond Lights”, Camel Blue described as “Camel Lights”, Camel Silver described as “Camel Super Lights”, Davidoff Gold described as “Davidoff Slim Lights”, Kent HD Premium Nr. 8 Futura described as “Kent Premium Lights Nr. 8”, Kent HD Nr. 4 Neo described as “Kent Super Lights Nr. 4”, L&M Blue Label described as “L&M Lights”, L&M Silver Label described as “L&M Super Lights”, Lucky Strike Blue described as “Lucky Strike Lights”, Magna Blue described as “Magna Lights”, Marlboro Gold Original described as “Marlboro Lights”, Marlboro Gold Accent described as “Marlboro Accent (Ultra Lights)”, Marlboro Silver described as “Marlboro Ultra Lights”, More Subtle Silver described as “More Super Lights”, Pall Mall Blue described as “Pall Mall Blue (Lights)”, Parliament Silver Blue described as “Parliament Extra Lights”, Parliament Aqua Blue described as “Parliament Lights”, Sovereign Slim Ultra 100’s described as “Sovereign Slim Ultra Lights 100’s”, Winston Balanced Blue described as “Winston Lights”, and Winston Subtle Silver described as “Winston Super Lights”.
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)). 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 website uses the descriptors “Lights” or “Super 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)).
Flavored Cigarette Violations
Additionally,our review of the website, http://www.cigarettes-shop.net, revealed that you offer for sale the following cigarettes: Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Super Slims Clubnichka 100s (strawberry), Kiss Super Slims Fresh Apple 100’s, and Richmond Cherry, 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)) 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 or misleading because it makes the representation that the products contain, for example, apple, cherry, rum & cherry, or strawberry as a 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 this website, 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, RW1300090, 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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
CSL Computer Service Langenbach GmbH d/b/a joker.com
Groupe iWeb Technologies Inc.