Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwcheapcigarettescoza-03232015
Timestamp: 2019-07-21 19:47:57
Document Index: 588869289

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

www.cheapcigarettes.co.za - 03/23/2015 | FDA
www.cheapcigarettes.co.za - 03/23/2015
www.cheapcigarettes.co.za Mar 23, 2015
www.cheapcigarettes.co.za
Star Trading cc T/A Afritrade
webpro@webpro.co.za
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites http://www.cheap-cigarettes.co.za, http://www.cigarette.co.za, http://www.buy-cigarettes-online.co.za, and http://www.discount-cigarettes.co.za, and determined that your cigarette products listed there are offered for sale or distributed to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the 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)).
You sell or distribute cigarette products that you describe on the websites, http://www.cheap-cigarettes.co.za, http://www.cigarette.co.za, http://www.buy-cigarettes-online.co.za, and http://www.discount-cigarettes.co.za, as being light by referring to them as such in product labeling or advertising and/or adding the qualifiers “Lights” to the product names. Specifically, our review of the websites revealed that you sell or distribute the following cigarette products described as “Lights,” including but not limited to: “Dunhill Lights (blue)” and “L D Liggett Ducat – Blue [lights].”
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “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)). 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)). Because the websites use the descriptor “Lights” or similar descriptors, for the above listed products, these products are modified risk tobacco 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 websites, http://www.cheap-cigarettes.co.za, http://www.cigarette.co.za, http://www.buy-cigarettes-online.co.za, and http://www.discount-cigarettes.co.za, revealed that you offer for sale the following cigarette products: “Rothmans Mints,” “Sobranie Mint,” and “Sobranie Slims Mint,” which 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:
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, mint as a characterizing flavor of the tobacco products.
Please note your reference number, RW15000268 in your response and direct your response to the following address:
info@cheapcigarettes.co.za
info@cigarette.co.zainfo@discount-cigarettes.co.za
ZA Central Registry NPC (formerly UniForum S.A.)
support@co.za
Les Juby
Managing Partner, Prosoft Microsystems
domains@webpro.co.za