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  1. Warning Letters

CLOSEOUT LETTER

Smokers Outlet Online


Smokers Outlet Online

  

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

 

VIA Electronic Mail


MAY 13, 2014


Frederick Fogelman
To: fred@milbg.com


Dear Mr. Fogelman:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions included in your correspondences, dated April 24, 2014 and May 7, 2014, in response to our Warning Letter dated April 23, 2014. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter. Specifically, you no longer sell your pipe tobacco as "multi-use" and "RYO/MYO" (roll-your-own/make-your-own), which included modified risk tobacco products and flavored cigarette tobacco, on your website http://www.smokersoutletonline.com

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:

John Peeler
it-vendors@smokersoutletonline.com

Gregory Weiner
gweiner@pklaw.com

GoDaddy.com, LLC
abuse@godaddy.com

Hosting Service, Inc.
Attn: Matt McBridge
mmcbride@westhost.com
abuse@uk2group.com