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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

RSB Tobacco, Inc. - Close Out Letter 9/17/13

  

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

 

 

SEP 17, 2013


VIA UPS and Electronic Mail


Rose S. Bowen
President
RSB Tobacco, Inc.
217 Elliott Dixon Road
Ayden, NC 28513
roseb@rsbtobacco.com


Dear Ms. Bowen:

The United States Food and Drug Administration's Center for Tobacco Products has received your letter dated August 13, 2013, and completed an evaluation of your corrective actions in response to 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 removing the descriptors and advertisements on your website 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.


Sincerely,

/S/

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


VIA USPS

cc:

RSB Tobacco
Rose Bowen
Administrative Contact
P.O. Box 73
Farmville, NC 27828

RSB Tobacco
P.O. Box 70
Ayden, NC 28513

Samuel H. Poole, Attorney at Law
Wade II, Suite 400
5430 Wade Park Boulevard
P.O. Box 33009
Raleigh, NC 27636-3009