Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwcigoutletnet-09152015
Timestamp: 2020-08-07 17:14:16
Document Index: 648908371

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

www.cigoutlet.net - 09/15/2015 | FDA
www.cigoutlet.net - 09/15/2015
www.cigoutlet.net September 15, 2015
Khakhin Dmytro
support@cigoutlet.net; cigars@cigoutlet.net
Dear Mr. Dmytro:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.cigoutlet.net 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)).
Our review of the website, http://www.cigoutlet.net, revealed that you sell or distribute the cigarette products listed or described as being lights, mild, or using similar descriptors. Specifically, our review of your website revealed that you sell or distribute cigarette products under the heading “Lights Cigarettes,” for example: Bond Lights (Special Selection), Camel Lights (Blue), Davidoff Slim Lights (Gold) 100’s, Kent Lights Nr. 1 (Infina), L&M Lights (Blue), Marlboro Lights (Gold), Parliament Lights (Aqua Blue), Sobranie Blue, Winston Lights (Balanced Blue), Classic Blue, Davidoff iD Blue, Dunhill Fine Cut Dark Blue 100’s, Gauloises Blue (Filter), Golden Gate Blue, Kent HDi Blue, L&M Motion Blue (mini), LD Blue, Lucky Strike Lights (Blue), Magna Blue (Lights), Marlboro Blue Fresh (Menthol), Monte Carlo Blue 100’s, Pall Mall Blue (Lights) (also described as “lights”), Pall Mall Lights (Blue), and Peter I Lights N8.
You also sell or distribute cigarette products under the heading “Ultra Lights Cigarettes,” for example: Kent Super Lights Nr. 4 (Neo), L&M Super Lights (Silver Label), Parliament Extra Lights (Silver Blue), Sobranie Classic Silver, West Silver Compact, Winston Super Lights (Subtle Silver), Bond Super Slims Silver 100’s, Camel Super Lights (Silver), Classic Slims Silver, Davidoff Super Slims Silver, Kent HDs Silver Super Slims 100s, L&M Motion Silver (mini), LD Silver Cigarettes, Lucky Strike Original Silver, Marlboro Ultra Lights (Silver) (also described as “milder”), More Super Lights (Subtle Silver), Muratti Silver Slims 100’s, Pall Mall Super Slims Silver 100’s, Peter I Super Lights N4, Prima Lux Silver, R1 Ultra Slim Line, Rothmans Silver, Russian Style Super Lights, Sobranie Classic Ultra, Sovereign Slim Ultra Lights 100’s, West Silver Fusion, West Ultra, and Winston XSence Silver (mini).
Additionally, our review of your website revealed that you offer for sale or distribute the following cigarette products: Beratt XL (described as “light”); and Chesterfield Agate Super Slims 100’s, Chesterfield Ivory Super Slims 100’s, and Chesterfield Red (Classic) (described as “mild”).
In addition, you sell or distribute cigarette products on the website that are described as containing a reduced level of a substance, presenting a reduced risk of exposure to a substance, or as being less harmful than one or more other commercially marketed products. Specifically, the website describes cigarettes that are listed under the heading “Lights Cigarettes” as “‘low-tar,’ ‘mild,’ or ‘low-yield’ cigarettes” and as having “filter[s that are] perforated with small holes that vaporize the tobacco smoke with clean air.” You also offer for sale or distribute cigarette products listed under the heading “Ultra Lights Cigarettes,” which are described as, “produc[ing] the minimum content of nicotine and tar. The effect is achieved by special filters laced with holes which diffuse the tobacco smoke with clean air. These perforations are designed to prevent the smoker from ingesting the full amount of nicotine and tar while smoking” and as having “the diluted smoke [that] doesn’t irritate the throat.”
You also offer for sale or distribute the following cigarettes products on the website: Aroma Rich Apple cigarettes, described as having “low levels of nicotine”; Marlboro Ultra Lights (Silver) cigarettes, described as having a “filter [that] is penetrated with holes which diffuse the tobacco smoke with fresh air. Thus the smoker is prevented from ingesting the full amount of nicotine,” and having “much less nicotine and tar content than Marlboro Red. The tobacco is milder, the test is really smooth and does not irritate the throat” and “minimum harm to human health”; Style brand, described as having “less tar, less nicotine, less smoke”; and Virginia brand, described as “reduc[ing] the amount of smoke.”
The above listed products are modified risk tobacco products because website uses the descriptors light, mild, or similar descriptors to describe these products or as containing a reduced level of a substance, presenting a reduced risk of exposure to a substance, or as being less harmful than one or more other commercially marketed products for the above listed 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.cigoutlet.net, revealed that you offer for sale or distribute the following cigarette products:Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Mohito (mini) (sic), Kiss Super Slims Clubnichka 100’s (strawberry), Kiss Super Slims Fresh Apple, Richmond Cherry, Richmond Cherry 4, Richmond Cherry Gold Super Slims 100s, Richmond Cherry Super Slims 100s, and Sobranie Slims Mints 100s. These products 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 their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum & cherry, mojito, strawberry, mint, or cherry as a characterizing flavor of the tobacco products.
Please note your reference number, RW1500379, in your response and direct your response to the following address:
khakhindymtro@gmail.com
CSL Computer Service Lagenbach GmbH
d/b/a joker.com
NetNucleus USA Inc