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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pamco - Close Out Letter 11/26/2012

  

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

Public Health Service
Food and Drug Administration
 Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229

VIA UPS


Patrick Shehan
President
Pamco Inc., d/b/a Tar Heel Tobacco
3193 Peter's Creek Parkway F
Winston-Salem NC, 27127-4710

NOV 26 2012


Dear Mr. Shehan:


The Food and Drug Administration's Center for Tobacco Products (CTP) has completed an evaluation of your corrective actions in response to our Warning Letter dated April 19, 2012. Based on our evaluation, it
appears that you have addressed the violations contained in the Warning Letter. Specifically, your April 23, 2012, response to our Warning Letter indicated that Pamco, Inc. (Pamco) will no longer advertise its
smokeless tobacco products without the required warning statements. Furthermore, during the September 24, 2012, teleconference with CTP, you stated that Pamco does not currently plan to advertise its smokeless
tobacco products in the near future.

Should you decide to advertise your smokeless tobacco products, we remind you that you are responsible for compliance with all requirements under Section 3 of the Comprehensive Smokeless Tobacco Health Education Act, as amended by the Family Smoking Prevention and Tobacco Control Act, including the requirements relating to size, formatting, location, and use of required warning statements, and applicable
requirements under the Federal Food, Drug and Cosmetic Act.

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 lbarra-Pratt
Group Leader
Promotion. Advertising, and Labeling Group
Office of Compliance and Enforcement
Center for Tobacco Products