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  5. www.smokecitymichigan.com - 09/25/2014
  1. Warning Letters

CLOSEOUT LETTER

www.smokecitymichigan.com


Recipient:
www.smokecitymichigan.com

United States

Issuing Office:

United States


  

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 20993-0002

 

SEP 25, 2014


VIA UPS


Phillip Lazaroff
Smoke City
619 E. Michigan Avenue
Jackson, MI 49201


Dear Mr. Lazaroff:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated February 11, 2014. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by including smokeless tobacco health warnings on your website, http://www.smokecitymichigan.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), as amended by the Family Smoking Prevention and Tobacco Control Act, 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/

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:

Phillip A Lazaroff
3037 Fawn Lane
Jackson, MI 49201

Philip A Lazaroff
Smoke City
4546 Page Avenue
Michigan Center, MI 49254

Sodium Technologies
sodiumtechnologies@gmail.com

Maxwell Lazaroff
therascalking13@gmail.com

GoDaddy.com, LLC
abuse@godaddy.com