Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwdutyfreeio-03302016
Timestamp: 2020-06-05 23:37:00
Document Index: 680471126

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

www.dutyfree.io - 03/30/2016 | FDA
www.dutyfree.io - 03/30/2016
www.dutyfree.io March 30, 2016
www.dutyfree.io
To: hello@dutyfree.io
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.dutyfree.io 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 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.
Our review of the website http://www.dutyfree.io revealed that you sell or distribute the following cigarette products listed under the heading “Lights”: Marlboro Gold, Camel Blue, Chesterfield Blue, Winston Blue, Lucky Strike Blue, Davidoff Gold, L&M Blue Label, Kent Convertibles, Parliament Aqua Blue, Bond Blue, Monte Carlo Blue, Kent Neo 4, Glamour Slims Blossom, Davidoff Blue, Parliament Silver Blue, Bond Silver, Kiss Superslims Romantic, Marlboro Flavor Note, Vogue Slims Bleue, Parliament One, Karelia Slims, Kent White Infina 1, Davidoff Slims Gold, Kent Slims Neo, Davidoff Slims Black, Davidoff Slims White, Esse Slims Classic, and Kent Slims Infina. Additionally, you sell or distribute the following cigarette products listed under the heading “Extra lights”: Vogue Slims Lilas, Glamour Slims Blossom, Davidoff Blue, Parliament Silver Blue, Vogue Slims Platine, Parliament One, Kent White Infina 1, Kent Slims Neo, Davidoff Slims White, and Kent Slims Infina.
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” “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)).
The above listed products are modified risk tobacco products because the website uses the descriptor 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)).
Please note your reference number, RW1600481, in your response and direct your response to the following address:
HCRYMPJCD@WHOISPRIVACYPROTECT.COM