Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwciga7com-12312015
Timestamp: 2020-04-01 13:11:51
Document Index: 406802321

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

www.ciga7.com - 12/31/2015 | FDA
www.ciga7.com - 12/31/2015
www.ciga7.com December 31, 2015
www.ciga7.com
To: support@ciga7.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.ciga7.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)).
Our review of the website http://www.ciga7.com revealed that you sell or distribute cigarette products, which are listed or described as being light, mild, or using similar descriptors, for example: Bond Street Special Selection (“Bond Lights (Special Selection),” also described as “milder”), Davidoff Slims Gold (“Davidoff Slim Lights (Gold) 100’s” and “Davidoff Slims Lights 100’s”), Kent HD (“Kent Lights Nr. 1 (Infinia)”), L&M Silver Label (“L&M Super Lights (Silver Label)”), Lucky Strike Blue (“Lucky Strike Lights (Blue)”), Marlboro Gold Accent (“Marlboro Accent (Ultra Lights)”), Pall Mall Blue (“Pall Mall Blue (Lights)”), Parliament Lights (described as “mild”), R1 Minima Slim Line 100’s and R1 Ultra Slim Line (described as “mild” and “light”), Sobranie Cocktail (described as “mild”), Sovereign Slims Ultra (“Sovereign Slim Ultra Lights 100’s”), and Winston Blue (“Winston Lights (Balanced Blue)”).
In addition, you sell or distribute cigarette products that are described as being less harmful than one or more other commercially marketed tobacco products or having a reduced level of/exposure to a substance. Specifically, the website includes the following claims: Davidoff brand, described as being “safer and healthier to smoke than other cigarette brands”; Muratti One, described as having “an extremely low rate of nicotine and tar”; Parliament Lights, described as containing “low levels of tar, so they are . . . relatively harmless”; and Viceroy brand, described as “prevent[ing] toxic chemicals from entering the smoker’s lungs” and having a “filter [that] reduce[s] the use of chemical additives and also makes the cigarette much
. . . cleaner.”
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 it describes them as being less harmful than one or more other commercially marketed tobacco products or having a reduced level of/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.ciga7.com revealed that you offer for sale or distribute cigarette products, for example: Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Super Slims Clubnichka 100’s (strawberry), Kiss Super Slims Fresh Apple 100’s, Kiss Mohito (mini), Richmond Cherry, Richmond Cherry 4, Richmond Cherry Gold Super Slims 100s, Richmond Cherry Super Slims 100s, and Sobranie Slims Mints 100’s.
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, strawberry, mojito, cherry, or mint as a characterizing flavor of the tobacco products.
Please note your reference number, RW1500414, in your response and direct your response to the following address:
GuangDong NaiSiNiKe Information Technology Co Ltd. (IISP.COM)
GuangDong NaiSiNiKe Information Technology Information Co. Ltd.