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  5. Smoker Friendly International, LLC - 09/19/2014
  1. Warning Letters


Smoker Friendly International, LLC

Smoker Friendly International, LLC

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

 Food and Drug Administration
Center for Tobacco Products
10003 New Hampshire Avenue
Silver Spring, MD 20993-0002


VIA Electronic Mail


Smoker Friendly International, LLC
Terrence P. Gallagher, CEO

Dear Mr. Gallagher:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions included in your letter dated August 4, 2014, in response to our Warning Letter dated July 21, 2014. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by no longer offering for sale or distributing misbranded and/or adulterated cigarette tobacco or roll-your-own tobacco products to consumers 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.




Ele Ibarra-Pratt
Division Director
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products


VIA Electronic Mail and UPS


Kenneth S. Kramer
General Counsel and Vice President - Administration
Smoker Friendly International, LLC
6790 Winchester Circle
Boulder, CO 80301

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