| Public Health Service Food and Drug Administration |
Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD 20850-3229 |
Department of Health and Human ServicesAUG 17 2011
VIA Electronic Mail
WARNING LETTER
Dear Sir or Madam:
The Food and Drug Administration (FDA) recently reviewed the websites www.cigs4u.net and www.eugcr.net and determined that your cigarette products listed there are offered for sale to U.S. customers. FDAbelieves these websites are affiliated with one another because they have the same contact phone number, 347-788-0948. 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 Kiss Superslims Energy (Peach Flavor), Kiss Superslims Fresh Apple, and Kiss Superslims Strawberry 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.
Specifically, you describe products that you offer for sale on your websites, www.cigs4u.net and www.eugcr.net, as being light, super light, and ultra light by referring to them as such in product advertising and adding the qualifiers “light” and “ultra light” to the product names. Our review of your websites revealed that you offered for sale products listed as “Marlboro Gold (Lights),” “Pall Mall Azure (Super Light),” “Pall Mall Blue Light,” “West Silver Lights,” and “West Blue Ultra Light” cigarettes. You also offer for sale LD Dukat Blue cigarettes, which you describe as “cheap ld dukat blue lights cigarettes,” LD SuperSlim Pink cigarettes, which you describe as “LD SuperSlims lights cigarettes,” President Fine Stars cigarettes, which you describe as “president ultra lights discount cigarettes,” and President Special Stars cigarettes, which you describe as “president lights discount 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)). 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,” “super slight,” “ultra light” or other similar descriptors for the above-listed 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 section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Additionally, our review of www.cigs4u.net and www.eugcr.net revealed that you offer for sale the following cigarettes: Kiss Superslims Energy (Peach Flavor), Kiss Superslims Fresh Apple, and Kiss Superslims Strawberry, 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, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, 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 peach, apple, 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 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
cc:
Tucows, Inc.
96 Mowat Ave.
Toronto, ON M6K 3M1
Canada
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