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  5. Store2Door - 02/29/2016
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WARNING LETTER

Store2Door Feb 29, 2016

Store2Door - 02/29/2016


Delivery Method:
UPS and Electronic Mail

Recipient:
Store2Door

3801 W. Magnolia Blvd.

Burbank, CA 91505
United States

Issuing Office:
Center for Tobacco Products

United States


  

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 29, 2016

VIA UPS and Electronic Mail
 
Store2door, Inc.
Attn: Aleksandr Kleyner
3801 W. Magnolia Blvd.
Burbank, CA 91505
alexkleyner@sbcglobal.net; HQ@store2door.us; webmaster@store2door.us; customercervice@store2door.us
 
WARNING LETTER
 
Dear Mr. Kleyner:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.store2door.us 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, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
 
FDA has determined that the Djarum Special (clove) cigarettes 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. Additionally, FDA has determined that the Djarum Special (clove) cigarettes are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) 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 their labeling or advertising purports that the product contains fewer than 20 cigarettes. 
 
Flavored Cigarette Violation
 
Our review of the website http://www.store2door.us revealed that you offer for sale or distribute Djarum Special (clove) cigarettes.  
 
This product ispurported to contain an artificial or natural flavor that is a characterizing flavor of the product. 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.
 
Cigarettes that are distributed or offered for sale in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).  Thus, your flavored cigarette product isadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, the cigarette product does not contain a characterizing flavor, it ismisbranded 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 itslabeling or advertising is false or misleading because it makes the representation that the product contains cloveas a characterizing flavor of the tobacco product.
 
Minimum Cigarette Package Size Violation
 
Our review of the website http://www.store2door.us revealed that you offer for sale or distribute Djarum Special (clove) cigarettes that are represented as containing 12 cigarettes per package. 
 
Under 21 C.F.R. § 1140.16(b), no retailer may sell or distribute, or cause to be sold or distributed, any cigarette package that contains fewer than 20 cigarettes. Cigarettes that are sold or distributed in the United States in violation of 21 C.F.R. § 1140.16(b) are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). Thus, if your Djarum Special (clove) cigarette product contains less than 20 cigarettes per package, it is misbranded under 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
 
If, however, the cigarette package contains 20 cigarettes or more, it ismisbranded 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 itslabeling or advertising is false or misleading because it makes the representation that the product contains fewer than 20 cigarettes.
 
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 thiswebsite, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, andin any retail establishments 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, RW1600455, 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:
 
Melbourne IT Ltd.
abuse@melbourneit.com.au
 
Network Solutions, LLC
nocsupport@networksolutions.com
abuse@web.com
 
Verio Hostmaster
abuse@verio.com
 
hostmaster@rapidsite.net

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