Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/www200cigsonlinecom-06172015
Timestamp: 2019-09-20 21:25:31
Document Index: 600329932

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

www.200cigsonline.com - 06/17/2015 | FDA
www.200cigsonline.com - 06/17/2015
www.200cigsonline.com June 17, 2015
To: support@200cigsonline.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.200cigsonline.com 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 cigarette products, 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. 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.
Our review of the website, http://www.200cigsonline.com, revealed that you sell or distribute the following cigarette products, which are listed or described as being “light,” or using similar descriptors, including, but not limited to: Bond Street Special Selection (“Bond Lights (Special Selection)”), L&M Blue Label (“L&M Lights (Blue)”), Lucky Strike Blue (“Lucky Strike Lights (Blue)”), Marlboro Gold Accent (“Marlboro Accent (Ultra Lights)”), Pall Mall (“Pall Mall Lights (Blue)”), and Winston Balanced Blue (“Winston Lights (Balanced Blue”).
Additionally, our review of the website, http://www.200cigsonline.com, revealed that you offer for sale or distribute the following cigarette products including, but not limited to: Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Mohito(mini) (sic), Kiss Super Slims Clubnichka 100’s (strawberry), Kiss Super Slims Fresh Apple 100’s, and Richmond Cherry.
Please note your reference number, RW1500326, in your response and direct your response to the following address: