Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/httpwwwsupercigarettesshopcom-10262015
Timestamp: 2019-10-18 18:12:22
Document Index: 733007050

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

http://www.supercigarettesshop.com - 10/26/2015 | FDA
http://www.supercigarettesshop.com - 10/26/2015
http://www.supercigarettesshop.com October 26, 2015
http://www.supercigarettesshop.com
To: support@supercigarettesshop.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.supercigarettesshop.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 areadulterated 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 Sobranie Mints 100s cigarettes areadulterated 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.supercigarettesshop.com revealed that you sell or distribute cigarette products,which arelisted or described as being“light,” “mild,” or using similar descriptors, for example: April Passion Super Slims 100s (“lightness”), April Romance Super Slims 100s (“lightness”), Camel Blue (“Camel Lights”), Chesterfield Classic Blue (“Chesterfield Lights”), Chesterfield Classic Bronze (““Chesterfield Ultra Lights”), Esse Superslims Special Gold (“light”), Gauloises Blondes Red (““Gauloises Lights”), Gitanes Blondes Blanche (“light”), Kiss Energy Superslims (“light”), Magna Balanced Blue (“Magna Blue (Lights)”), Richmond in Metal Slide Box (“milder”), Ronson White (“Ronson Lights”), Three Kings Blue (“light”), Three Kings Red Filter (“light”), and Viceroy Blue (“light”). 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: Beverly Red and Beverly Blue, described as being “less harmful”; Camel One, described as having the “lowest content of tar and nicotine”; Dallas Blue, described as having “low tars and nicotine amount”; Esse, described as having a “level of tar and nicotine in them also lower than in other smokes”; Kool Menthol, described as having “decreased tar”; and Richmond in Metal Slide Box, described as having “low nicotine.”
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 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.supercigarettesshop.com revealed that you offer for sale or distribute the following cigarette product: Sobranie Mints 100s. This product ispurported 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:
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 product isadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, this cigarette product does not contain a characterizing flavor, it is 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 product contains mint as a characterizing flavor of the tobacco product.
Please note your reference number, RW1500411, in your response and direct your response to the following address:
c/o SafestWhois (TM)
csrcontact@cscinfo.com
support_center@cscinfo.com
abuse@ipipe.net
Overoptic Systems Ltd. Tech
abuse@hqhost.net
hostmaster@server4shops.com
hostmaster@ipipe.net
http://www.supercigarettesshop.com - Close Out Letter 3/16/16