Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cigarettes-cheapercom-12312015
Timestamp: 2019-05-23 17:13:01
Document Index: 577714637

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

cigarettes-cheaper.com - 12/31/2015 | FDA
cigarettes-cheaper.com - 12/31/2015
cigarettes-cheaper.com 31/12/2015
cigarettes-cheaper.com
To: usatocig@gmail.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.cigarettes-cheaper.com and determined that the cigarette products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (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 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 Kiss Superslims Fresh Apple and Sobranie Mints Slim 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.
Our review of the website http://www.cigarettes-cheaper.com revealed that you sell or distribute cigarette products,which arelisted or described as being light, mild, or using similar descriptors, for example: “Chesterfield Classic (Lights) Blue,” “Davidoff Gold (Lights),” “Davidoff One (Ultra Lights),” “Gauloises Blondes Ultra Light,” “Golden Gate Light KS,” “L&M Blue Label Lights,” “Magna Blue (Light),” “Marlboro (Silver) Super Light,” “More Subtle Silver (Super Lights),” “Optima Gold (Lights),” “Pall Mall (Blue) Light,” “Prima Lux Sribna Ultra Lights,” “Prima Lux Zolota (Super Light),” “Rothmans Red Special Mild,” “Vatra Lights,” and “Viceroy Silver Ultra Lights.” In addition, you sell or distribute cigarette products that are described as having a reduced level of/exposure to a substance. Specifically, the website includes the following claims: George Karelia & Son Superior Virginia, described as having “lower nicotine levels”; Raquel Slims Blue 100, described as having “low tar and nicotine”; Silk Cut KS Filter, described as having “lower tar”; and Winston Blue Super Slim, described as having “low-nicotine.”
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” “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)).
The above listed products are modified risk tobacco products because the website uses the descriptors light, mild, or similar descriptors to describe these products or describes them as containing a reduced level of a substance or presenting a reduced exposure to a substance. 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.cigarettes-cheaper.com revealed that you offer for sale or distribution the following cigarette products: Kiss Superslims Fresh Apple and Sobranie Mints Slim.
These products are purported 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:
Cigarettes that are distributed or 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 cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
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 mint as a characterizing flavor of the tobacco products.
Please note your reference number, RW1500399, in your response and direct your response to the following address:
3758CE8A74C7485E84D6DA2576A6770D.protect@whoisguard.com