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CLOSEOUT LETTER

El Fumador Cigars Pipes Tobacco, Inc. Dec 30, 2015

El Fumador Cigars Pipes Tobacco, Inc. - Close Out Letter 12/30/15


El Fumador Cigars Pipes Tobacco, Inc.

  

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 30 2015
 

El Fumador Cigars Pipes Tobacco, Inc.
d/b/a El Fumador
Attn: Ed Maidel
info@elfumador.com

Dear Mr. Maidel:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your letter dated August 31, 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 offering for sale or distribution modified risk tobacco products or misbranded smokeless tobacco products on your website http://www.elfumador.com.

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 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/

Bryan Hills
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products


VIA Electronic Mail

cc:

El Fumador Cigars Pipes Tobacco, Inc.
d/b/a El Fumador
el.fumador@verizon.net

Bobby Holstein
bobby@fujipub.com
hostmaster@fujipub.com

Melbourne IT Ltd.
abuse@melbourneit.com.au

NTT America, Inc.
abuse@ntt.net

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