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  1. Warning Letters

CLOSEOUT LETTER

Cigar Town


Cigar Town

  

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 

NOV 05 2015

VIA Electronic Mail

Michael Barletta / Tom Trella
info@cigartown.net


Dear Mr. Barletta and Mr. Trella:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions described in your emails dated May 6 and September 18, September 18, and September 24, 2015, in response to our Warning Letter dated May 6, 2015. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter regarding your website by displaying health warning statements with smokeless tobacco products that you sell or distribute on http://www.cigartown.net.

We remind you that you are also required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA. We also remind you to submit a notification 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:

Cigar Town / Cigar Box
info@cigarboxpa.com

David Kunstek
davidk@pageonewd.com

PageOne Website Design and Web Development
info@PageOneWD.com, Tom@capriottisinc.com

GoDaddy.com, LLC
abuse@godaddy.com

Liquid Web, Inc.
abuse@liquidweb.com, abuse@sourcedns.com