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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.tobaccocityfargo.com - Close Out Letter 4/4/14

  

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

 
 Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229

 

APR 4, 2014


VIA Electronic Mail


Troy R. Sundby, General Manager
Tobacco City, Inc.
2701 University Drive South
Fargo, ND 58103
sales@tobaccocityfargo.com
troy@tobaccocityfarqo.com


Dear Mr. Sundby:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated October 26, 2013. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by taking down the website http://www.tobaccocityfargo.com.

We remind you that you are required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Smokeless Tobacco Act (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 for all tobacco products and all related promotional materials for which you or your firm are responsible. 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