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CLOSEOUT LETTER

Dwyer & Manning Inc


Dwyer & Manning 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

 

JAN 15, 2015
 


William L. Miller
Dwyer & Manning, Inc.
5348 Vegas Drive
Box #1559
Las Vegas, NV 89108
cs@MakeRollYourOwnCigarettes.com


Dear Mr. Miller:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in the response received August 22, 2014, in response to our Warning Letter dated July 28, 2014. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter for http://www.makerollyourowncigarettes.com by no longer offering for sale your cigarette tobacco and/or roll-your-own tobacco, which were adulterated under 902(8) of the Federal Food, Drug & Cosmetic Act (FD&C Act) (21 U.S.C. § 387b(8)). Additionally, you have discontinued use of smokeless tobacco product advertisements that do not comply with applicable requirements under the FD&C Act. Specifically, you removed the website and it is no longer active.

We remind you that you are also required to follow all other applicable federal laws and regulations should you resume advertising your smokeless tobacco products. 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

 

VIA UPS and Electronic Mail


cc:
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Las Vegas, Nevada 89148

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