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CLOSEOUT LETTER

Swisher International, Inc. Aug 23, 2016

Swisher International, Inc. - Close Out Letter 8/23/16


Swisher International, Inc.

  

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 

AUG 23 2016
 

VIA UPS

Peter J. Ghiloni
President
Swisher International Inc.
459 East 16th Street
Jacksonville, FL 32206


Dear Mr. Ghiloni:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your letters dated November 17, 2015 and January 14, 2016, in response to our Warning Letter dated November 2, 2015. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by discontinuing smokeless product advertisements or labeling on https://www.facebook.com/SwisherXtreme, https://twitter.com/SwisherXtreme, and https://www.instragram.com/swisherxtreme that do not comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act (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 FD&C 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:
Christopher L. Casey
Senior VP, General Counsel
459 E. 16th St.
Jacksonville, FL. 32206

tmaldonado@swisher.com
abuse@web.com