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CLOSEOUT LETTER

Tobacco Barn Tucson 30/12/2015

Tobacco Barn Tucson - Close Out Letter 12/30/15


Tobacco Barn Tucson

  

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 

VIA UPS

DEC 30 2015
 

Tobacco Barn Tucson
Attn: Fitzpatrick Ignacio
7310 S. Nogales Highway
Tucson, AZ 85706

Dear Mr. Ignacio:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated August 18, 2015. Based on our evaluation, it appears that you have addressed the violation contained in the Warning Letter by no longer advertising misbranded smokeless tobacco products on your website http://www.tobaccobarntucson.com.

We remind you that you are also required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402) requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic 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/

Bryan Hills
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products


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