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  1. Warning Letters

CLOSEOUT LETTER

http://www.okcigarettes.com


http://www.okcigarettes.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 

SEP 22 2015
 

VIA Electronic Mail

To: BF052A4CA0A44F4789B44B41584B2D7D.protect@whoisguard.com

To Whom It May Concern:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated June 18, 2015. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by no longer offering for sale modified risk tobacco products or flavored cigarettes on http://www.okcigarettes.com.

We remind you to submit notifications to FDA if you intend to disseminate advertising or labeling in a medium not listed under 21 C.F.R. § 1140.30(a)(1).

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 Electronic Mail

cc:

eNom, Inc.
abuse@enom.com

Linode Network Operations
abuse@linode.com