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CLOSEOUT LETTER

Whole Leaf Tobacco (Don Carey) 21/08/2015

Whole Leaf Tobacco (Don Carey) - Close Out Letter 8/21/15


Whole Leaf Tobacco (Don Carey)

  

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 

VIA UPS and Electronic Mail

AUG 21, 2015
 

Donald Carey
Whole Leaf Tobacco LLC
Don@WholeLeafTobacco.com

Dear Mr. Carey:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of the corrective actions described in your letter dated April 22, 2015, in response to our Warning Letter dated April 6, 2015. Based on our evaluation of your website, http://www.wholeleaftobacco.com, it appears that you have addressed the violations contained in the Warning Letter by no longer offering for sale adulterated tobacco products 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


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