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CLOSEOUT LETTER

www.tobaccozoneplacentia.com Jan 29, 2015

www.tobaccozoneplacentia.com - Close Out Letter 1/29/15


www.tobaccozoneplacentia.com

  

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 

JAN 29, 2015
 

VIA UPS


Ashwin Patel
Tobacco Zone
901 E Yorba Linda Boulevard, Suite C
Placentia, CA 92870


Dear Mr. Patel:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated October 29, 2013. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by discontinuing smokeless tobacco product advertisements that do not comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the websites, http://www.tobaccozones.com and http://tobaccozoneplacentia.net, no longer advertise the misbranded smokeless tobacco products referenced in the Warning Letter or are no longer active.

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 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
Division Director
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products

 

cc:

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ashwinptl@gmail.com
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