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CLOSEOUT LETTER

Smoke Shop Plus 04/09/2014

Smoke Shop Plus - Close Out Letter 9/4/14


Smoke Shop Plus

  

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

 

VIA UPS and Electronic Mail


09/04/14


Dilipkumar Patel
13100 Magnolia Avenue, Suite E,
Corona, California 92879
fernsyaknow4@gmail.com


Dear Mr. Patel:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated February 12, 2014. 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 Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, http://www.magnoliasmokeshop.com now includes smokeless tobacco warning statements.

We remind you that you are also required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (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


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