Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/www200cheapcigarettescom-06062014
Timestamp: 2019-10-23 13:52:12
Document Index: 593720432

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

www.200cheapcigarettes.com - 06/06/2014 | FDA
www.200cheapcigarettes.com - 06/06/2014
www.200cheapcigarettes.com June 06, 2014
www.200cheapcigarettes.com
To: Support@200cheapcigarettes.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.200cheapcigarettes.com, and determined that your cigarette products listed there are 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 of your products are adulterated 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 of your 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
You sell or distribute products that you describe on the website, http://www.200cheapcigarettes.com, as being light or ultra light by referring to them as such in product labeling or advertising and adding the qualifiers “Lights” or “Ultra Lights” to the product names. Specifically, our review of the website revealed that you sell or distribute products listed as: “Bond Lights (Special Selection),” “Camel Lights (Blue),” “Davidoff Slim Lights(Gold) 100’s,” “Kent Lights Nr. 1 (Infina),” “Kent Premium Lights Nr. 8 (Futura),” “L&M Lights (Blue),” “Lucky Strike Lights (Blue),” “Marlboro Lights (Gold),” “Pall Mall Super Slims Blue (Lights) 100’s,” “Pall Mall Blue (Lights),” “Parliament Lights (Aqua Blue),” Sovereign Slims Ultra described as “Sovereign Slim Ultra Lights 100’s,” “Marlboro Accent (Ultra Lights),” “Marlboro Ultra Lights (Silver),” “Winston Super Lights (Subtle Silver),” “Camel Super Lights (Silver),” “Kent Super Lights Nr. 4 (Neo),” “L&M Super Lights (Silver Label),” and “Parliament Extra Lights (Silver Blue).”
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 “Lights” or “Ultra 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 website, http://www.200cheapcigarettes.com, revealed that you offer for sale the following cigarette products: “Aroma Rich Apple,” “Aroma Rich Rum & Cherry,” “Kiss Mohito(mini),” “Kiss Super Slims Clubnichka 100’s” (strawberry), “Kiss Super Slims Fresh Apple 100’s,” “Richmond Cherry,” “Richmond Cherry 4,” “Richmond Cherry Gold Super Slims 100s,” “Richmond Cherry Super Slims 100s,” 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, the 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, mohito, strawberry, cherry, or mint as a characterizing flavor of the tobacco products.
Please note your reference number, RW1400168, in your response and direct your response to the following address:
200cheapcigarettes.com@iprivacyltd.com
Support@iprivacyltd.com