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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gatlinburlier, Inc. - Close Out Letter 11/26/13


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


NOV 26, 2013


VIA UPS and Electronic Mail

Ira T. Lapides
Gatlinburlier, Inc.
611 Parkway, Suite D1
Gatlinburg, TN 37738


Dear Mr. Lapides:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated, August 28, 2013. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by discontinuing smokeless tobacco product advertisements that do not comply with applicable requirements under the FD&C Act. Specifically, you removed all smokeless tobacco products from your websites, http://www.gatlinburlier.com and http://www.gbtobacco.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.




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


The Gatlinburlier
603 Skyline Drive
Gatlinburg, TN 37738