Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/httpcigs4me-03132016
Timestamp: 2019-09-21 20:11:12
Document Index: 4758547

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

http://cigs4.me - 03/13/2016 | FDA
http://cigs4.me - 03/13/2016
http://cigs4.me March 13, 2016
http://cigs4.me
support@cigs4.me
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://cigs4.me 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 Corset Mintbreeze Superslims 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://cigs4.me revealed that you sell or distribute the following cigarette products, which are listed or described as being light, mild, or using similar descriptors: Camel (“Camel Mild”), Gitanes Blondes (“Gitanes Blondes Light”), L&M Blue (“L&M Box Light/Blue”), Rothmans Red (“Rothmans Red Special Mild”), Salem Green (“Salem Green/Light Menthol”), West Silver (“West Silver/Lights”), and Winston Blue (“Winston Lights/Blue”).
The above listed products are modified risk tobacco products because http://cigs4.me uses the descriptors light, mild, or similar descriptors to describe these 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 http://cigs4.me revealed that you offer for sale or distribute the following cigarette product: Corset Mintbreeze Superslims.
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 itslabeling or advertising is false or misleading because it makes the representation that the product contains, for example, mint as a characterizing flavor of the tobacco product.
Please note your reference number, RW1600476, in your response and direct your response to the following address:
cigs4.me@domainnameproxyservice.com