Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm485634.htm
Timestamp: 2019-04-18 10:56:50
Document Index: 280345079

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

E Australia Consortium 2/3/16
help@tobacco.net.au; help@discountcigarettestore.co.uk; admin@discountcigarettestore.co.uk
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites http://www.tobacco.net.au and http://www.discountcigarettestore.co.uk and determined that the cigarette tobacco and/or roll-your-own tobacco 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 tobacco and roll-your-own 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 tobacco and/or roll-your-own tobacco products areadulterated 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.
Flavored Cigarette Tobacco and/or Roll-Your-Own Tobacco Violations
Our review of the websites, http://www.tobacco.net.au and http://www.discountcigarettestore.co.uk, revealed that you offer for sale or distribute the following cigarette tobacco and/or roll-your-own tobacco products: Port Royal Kentucky Bourbon 50g pouch, Port Royal Kentucky Bourbon 50g pouch (5x50g Pack), Port Royal Original 50 Grams Tobacco (rum & wine), and Port Royal Original 50 Grams Tobacco (5x50g Pack) (rum
& wine).
Cigarette tobacco and/or roll-your-own tobacco that is distributed or offered for sale in the United States in violation of this provision is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarette tobacco and/or roll-your-own tobacco products areadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, these cigarette tobacco and/or roll-your-own tobacco 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, bourbon or rum & wine as a characterizing flavor of the tobacco products.
Please note your reference number, RW1500428, in your response and direct your response to the following address:
Hatem Shahin
Shahin Investments Pty Ltd.
trent.g@tobacco.net.au
tshahin@tobacco.net.au
complaints@webregistrar.com.au
Crazy Domains FZ-LLC / Dreamscape Networks FZ-LLC
root@tobacco.net.au
root@discountcigarettestore.co.uk
root@cheapcigarettestobacco.co.uk