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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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George Nicolas - Close Out Letter 12/18/13

  

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

 

DEC 18, 2013


VIA Electronic Mail


George Nicolas
Buy21@live.com
admin@duty-free-store.com


Dear Mr. Nicolas:

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 March 21, 2013. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter regarding the websites, http://www.ineed-vip.com, http://www.payless-vip.com, and http://www.123-vip.com, by no longer selling or advertising modified risk tobacco products and by removing cigarettes that were purported to contain a characterizing flavor for sale to customers in the United States.

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 UPS and Electronic Mail

cc:

Network Solutions, LLC
13681 Sunrise Valley Drive, Suite 300,
Herndon, Virginia 20171

support@securest.biz
report@securest.biz
admin@duty-free-store.com