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  1. Compliance Actions and Activities

CLOSEOUT LETTER

Smoker Friendly 10/12/2014

Smoker Friendly - Close Out Letter 12/10/14


Smoker Friendly

  

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 

VIA ELECTRONIC MAIL

DEC 10, 2014
 

Steve Norman, President
Smoker Friendly
storman@suddenlinkmail.com

Dear Mr. Norman:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated July 14, 2014. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by discontinuing smokeless tobacco product advertisements on your website, http://www.smokerfriendlywv.com, that do not comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

We remind you that you are required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Smokeless Tobacco Act (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.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the FD&C 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:

Regan Bartley
Smoker Friendly
regan@smokerfriendlywv.com

Ryan Norman
Smoker Friendly
ryan@smokerfriendlywv.com

Dionne Sams
dmsams@biztec.us

GoDaddy.com, LLC
abuse@godaddy.com

Ron Tyson
NBS, Inc.
tron@suddenlinkmail.com

Power DNN
support@powerdnn.com