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  5. ITG Brands, LLC - Close Out Letter 9/5/17
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CLOSEOUT LETTER

ITG Brands, LLC Sep 05, 2017

ITG Brands, LLC - Close Out Letter 9/5/17


Recipient:
ITG Brands, LLC


United States

Issuing Office:

United States


  

Department of Health and Human Services logo

 
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

SEPT 9, 2017

David Taylor
Chief Executive Officer
ITG Brands, LLC
2525 E Market Street
Greensboro, NC 27401

Dear Mr. Taylor:

On August 27, 2015, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter for the sale or distribution of modified risk tobacco products without an FDA order in effect that permits such sale or distribution. Specifically, you sold or distributed Winston cigarettes described in product labeling as "Additive Free."

In response to the Warning Letter, you stated that you implemented corrective actions to address the violations identified in the Warning Letter. You also submitted revised labeling for your products pursuant to section 905(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA conducted an inspection of your manufacturing facility to confirm your corrective actions. After reviewing the results of this inspection, it appears that you have addressed the violations identified in the Warning Letter.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.

Sincerely,
/S/

Ele Ibarra-Pratt
Director
Division of Promotion, Advertising and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
 

VIA UPS

cc:

Katherine Giambrone
Chief Compliance Officer
ITG Brands, LLC
420 North English Street
Greensboro, NC 27405