Inspections, Compliance, Enforcement, and Criminal Investigations

Busch-Kearn Inc./Robert Busche and Jim Kearney - Close Out Letter 9/22/15

  

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 

SEP 22 2015
 

VIA Electronic Mail

Busch-Kearn Inc. / Robert Busche and Jim Kearney
d/b/a Puff Discount Tobacco
robertb@puff-discount.com

Dear Mr. Busche:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your email dated August 31, 2015 and letter dated September 1, 2015, in response to our Warning Letter dated August 31, 2015. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by no longer advertising smokeless tobacco products on your websites, http://www.puff-discount.com and http://www.puffdiscounttobacco.com.

We remind you to submit notifications 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:

Scott Busche
IT Manager
Busch-Kearn Inc.
d/b/a Puff Discount Tobacco
sbusche1@verizon.net

GoDaddy.com, LLC
abuse@godaddy.com

Lifeline Data Centers
arin-tech@lldc.net

Richard B. Irving
rirvinq@sinewavetech.com

dns@jomax.net

Unified Layer
abuse@unifiedlayer.com

Page Last Updated: 09/22/2015
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