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CLOSEOUT LETTER

Pipe World Inc


Pipe World 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 UPS and Electronic Mail

 

JUN 19 2015


Kyle Haass, Vice President
Pipe World, Inc.
115 Sundance Pkwy.
Suite 505
Round Rock, TX 78681
mail@pipeworld.com

Dear Mr. Haass:

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 April 6, 2015, in response to our Warning Letter dated April 2, 2015. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by discontinuing smokeless tobacco product advertisements on http://www.pipeworld.com, which do not comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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. We also 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 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/

Lucus Nelson
Branch Chief (Acting)
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products


VIA Electronic Mail

Pipeworld.com@contactprivacy.com

domainabuse@tucows.com

abuse@ecommerce.com