Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/you-me-cigars-tobacco-10272015
Timestamp: 2019-07-23 12:08:13
Document Index: 206300725

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 4402', '§ 387', '§ 387']

You & Me Cigars & Tobacco - 10/27/2015 | FDA
You & Me Cigars & Tobacco - 10/27/2015
You & Me Cigars & Tobacco Oct 27, 2015
You & Me Cigars & Tobacco
Plaitakis Iraklis
info@youandme.gr; logistirio@youandme.com; youandmecigars@abv.bg; peggy@tepostone.gr
Dear Mr. Iraklis:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites http://www.youandme.gr, http://www.nargiles.gr, and http://www.habanos.gr and determined that the cigarette and smokeless tobacco 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 and smokeless tobacco, 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 areadulterated 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 smokeless tobacco products aremisbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because the webpages regarding smokeless tobacco products fail to include any health warning label statements.
Our review of the websites, http://www.youandme.gr, http://www.nargiles.gr, and http://www.habanos.gr , revealed that you sell or distribute cigarette products,which arelisted or described as being“Lights” or using similar descriptors, for example: “GR Classic Lights,” “GR Classic Lights 100s,” “Karelias Superior Virginia Soft Lights,” and “Marlboro Mint Lights.”
The above listed products are modified risk tobacco products because the websites use the descriptors “Lights” 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 websites, http://www.youandme.gr, http://www.nargiles.gr, and http://www.habanos.gr, revealed that the following smokeless tobacco products that you offer for sale or distribute in the United States do not include any health warning statements: Tobacco Snuff Bernard 275th-Anniversary, Tobacco Snuff Bernard Amostrinhia, Tobacco Snuff Bernard Bavaria, Tobacco Snuff Bernard Brasil, Tobacco Snuff Bernard Elegand, Tobacco Snuff Bernard Kloster, Tobacco Snuff Bernard Polar, Tobacco Snuff Bernard Premium, and Tobacco Snuff MC Chrystal’s JIP. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846), requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
Because the webpagesregarding smokeless tobacco products donot include any health warnings, your smokeless tobacco products aremisbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).
Please note your reference number, RW1500403, in your response and direct your response to the following address:
returns@youandme.gr
abuse@hostmein.net
abuse@lancom.gr