Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/toque-snuff-limited-09222015
Timestamp: 2019-10-21 18:40:42
Document Index: 229932341

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 1140', '§ 387', 'art 1140', '§ 1140', '§ 387', '§ 4402', '§ 387', '§ 387']

Toque Snuff Limited - 09/22/2015 | FDA
Toque Snuff Limited - 09/22/2015
Toque Snuff Limited September 22, 2015
To: sales@toquesnuff.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.toquesnuff.com and determined that the 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 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 smokeless tobacco products aremisbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold these products to a person younger than 18 years of age. Additionally, FDA has determined that several smokeless tobacco products are misbranded 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 your website regarding smokeless tobacco products fails to include any health warning label statements.
FDA’s investigation of the website http://www.toquesnuff.com revealed that you sold smokeless tobacco products to a minor. Specifically, during our investigation of http://www.toquesnuff.com, a person younger than 18 years of age purchased Berwick Brown 10g Tin and Vanilla Bullet snuff from the website. No retailer may sell cigarettes, cigarette tobacco and/or roll-your-own tobacco, or smokeless tobacco to a person younger than 18 years of age under 21 C.F.R. § 1140.14(a). Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140. Because these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(a), these products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Additionally, our review of the website http://www.toquesnuff.com 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, for example: Absinthe Bullet, Almond Toast Bullet, Apricot Bullet, Berwick Brown Bullet, Blueberry Bullet, Bourbon Bullet, Chocolate Bullet, Christmas Pudding Bullet, Coke Bullet, Espresso Bullet, Ginger Bullet, Lavender Bullet, Lime Toast Bullet, Menthol Bullet, Peach Bullet, Peanut Butter Bullet, Peppermint Bullet, Pomegranate Bullet, Raspberry Bullet, Rose Bullet, Strawberry Bullet, Toffee Bullet, Vanilla Bullet, Violet Bullet, and Whisky & Honey Bullet. 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 your website regarding smokeless tobacco products does not include any health warnings, your smokeless tobacco products are misbranded 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, RW1500392, in your response and direct your response to the following address:
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