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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tobacco Outlet Express, LLC - Close Out Letter 10/7/13


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


OCT 7, 2013


Armand F. Nannicola
Tobacco Outlet Express, LLC
1100 Corby Drive
Youngstown, OH 44509

Donald Fleck
Tobacco Outlet Express, LLC
29072 Cedar Drive
Big Pine Key, FL 33043

Dear Mr. Nannicola and Mr. Fleck:

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 July 30, 2013. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by discontinuing advertisements on your website at http://www.smokin-g.com that caused your products to violate applicable provisions of the FD&C Act.

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.




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

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