Inspections, Compliance, Enforcement, and Criminal Investigations

E Australia Consortium 2/3/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

FEB 3, 2016

VIA Electronic Mail
 
E Australia Consortium
help@tobacco.net.au; help@discountcigarettestore.co.uk; admin@discountcigarettestore.co.uk
 
 
WARNING LETTER
 
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).
 
These products are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
 
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice . . . that is a characterizing flavor of the tobacco product or tobacco smoke.
 
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.
 
Conclusion and Requested Actions
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 
 
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on these websites, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.  Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
 
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Please note your reference number, RW1500428, in your response and direct your response to the following address:
 
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.   
 
 
Sincerely,
/S/ 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
 
VIA Electronic Mail
 
cc:
 
Hatem Shahin
Shahin Investments Pty Ltd.
trent.g@tobacco.net.au
tshahin@tobacco.net.au

Web Address Registration
complaints@webregistrar.com.au
 
Crazy Domains FZ-LLC / Dreamscape Networks FZ-LLC
abuse@crazydomains.com

SoftLayer Dutch Holdings B.V.
abuse@softlayer.com
 
root@tobacco.net.au

 
root@discountcigarettestore.co.uk

root@cheapcigarettestobacco.co.uk


 

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