Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwbuy-sigarettscom-01162014
Timestamp: 2019-07-21 02:11:38
Document Index: 516148428

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387']

www.buy-sigaretts.com - 01/16/2014 | FDA
www.buy-sigaretts.com - 01/16/2014
www.buy-sigaretts.com Jan 16, 2014
www.buy-sigaretts.com
http://www.buy-sigaretts.com
Internet Invest Ltd. d/b/a imena.ua
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.buy-sigaretts.com and determined that the 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 (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 cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. Additionally, FDA has determined that your Aroma Rich Apple and Aroma Rich Rum & Cherry cigarettes 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)) because they purport to contain a natural or artificial characterizing flavor. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
You sell or distribute cigarette products that you describe on the website, http://www.buy-sigaretts.com, as being light, super light, extra light, or ultra light by referring to them as such in product labeling or advertising and adding the qualifiers “Lights,” “Super Lights,” “Extra Lights,” or “Ultra Lights” to the product names. Specifically, our review of the website revealed that you sell or distribute products listed as: “Camel Lights (Blue),” “Camel Super Lights (Silver),” “Kent Premium Lights Nr. 8” (HD), “Kent Super Lights Nr. 4” (HD), “L&M Lights (Blue),” “L&M Super Lights (Silver Labled)” (sic), “Marlboro Accent Ultra Lights” (Marlboro Gold Accent), “Marlboro Lights Gold” (Marlboro Gold Original, also described as “light blended tobacco”), “Marlboro Ultra Lights Silver,” “Monte Carlo Lights (Balanced Blue),” “Parliament Extra Lights (Silver Blue),” “Parliament Lights (Aqua Blue),” “Winston Lights (Balanced Blue)” (also described as “lights cigarettes”), and “Winston Super Lights (Subtle Silver).” You also describe products you offer for sale on your website as being less harmful than one or more other commercially marketed products. Specifically, you offer for sale Marlboro Ultra Lights Silver “with the minimum harm to human health”.
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 the website uses the descriptors “Lights,” “Super Lights,” “Extra Lights,” “Ultra Lights,” or similar descriptors or claims to be less harmful to health for the above listed products, these products are modified risk tobacco products. Because these products are sold or distributed 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 the website, http://www.buy-sigaretts.com, revealed that you offer for sale the following cigarette products: Aroma Rich Apple and Aroma Rich Rum & Cherry, which arepurported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
If, however, these cigarette products 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 section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple or rum & cherry as a characterizing flavor of the tobacco products.
Please note your reference number, RW1400149, in your response and direct your response to the following address:
info@imena.ua
noc@mirohost.net
www.buy-sigaretts.com - Close Out Letter 3/7/14