Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/www200cheapcigscom-03272015
Timestamp: 2019-08-23 13:32:48
Document Index: 150311089

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

www.200cheapcigs.com - 03/27/2015 | FDA
www.200cheapcigs.com - 03/27/2015
www.200cheapcigs.com Mar 27, 2015
www.200cheapcigs.com
support@200cheapcigs.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.200cheapcigs.com, and determined that your cigarette products listed there are distributed or offered for sale 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)).
FDA has determined that several cigarette productsareadulterated 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 several cigarette products are adulterated 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.200cheapcigs.com, revealed that you sell or distribute the following cigarette productslisted or described in product labeling and/or advertising as being, for example, “Light,” “Ultra Light,” “Super Light,” or using similar descriptors: Bond Special Selection (Bond Lights (Special Selection)), Camel Silver (Camel Super Lights (Silver)), Kent HD (Kent Lights Nr. 1 (Infina)), L&M Blue Label (L&M Lights (Blue)), Lucky Strike Blue (Lucky Strike Lights (Blue)), Marlboro Gold Original (Marlboro Lights (Gold)), Pall Mall Blue (Pall Mall Blue (Lights)), Parliament Aqua Blue (Parliament Lights (Aqua Blue)), and Sovereign Slims Ultra (Sovereign Slim Ultra Lights 100’s).
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 your website uses the descriptor “Light,” “Ultra Light,” Super Light,” or similar descriptors, 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)).
The above listed products are modified risk tobacco products because the website uses the descriptors “Light,” “Ultra Light,” “Super Light,” 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 the website, http://www.200cheapcigs.com, revealed that you offer for sale or distribute cigarette products, including but not limited to the following: Aroma Rich Rum & Cherry, Kiss Mohito (mini), Kiss Super Slims Clubnichka 100’s (strawberry image), Kiss Super Slims Fresh Apple 100’s, Richmond Cherry, and Sobranie Slims Mints 100’s, 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 and/or advertising is false or misleading because it makes the representation that the products contain, for example, rum & cherry, mojito, strawberry, apple, or mint as a characterizing flavor of the tobacco products.
Please note your reference number, RW1500282, in your response and direct your response to the following address:
root@200cheapcigs.com