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CLOSEOUT LETTER

Hiland's Cigars 30/09/2015

Hiland's Cigars - Close Out Letter 9/30/15


Hiland's Cigars

  

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 

SEP 30, 2015

VIA Electronic Mail

Hiland's Cigars
Attn: John Hiland
hcigars@mindspring.com


Dear Mr. Hiland:

The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your email dated April 14, 2015, and your letters dated June 8, 2015 and July 10, 2015, in response to the issuance of our Warning Letter dated April 2, 2015. Based on our evaluation, it appears that you have implemented an online feature on http://www.hilandscigars.com to help prevent the sale of regulated tobacco products to minors. Additionally, you no longer offer for sale or distribution misbranded smokeless tobacco products on http://www.hilandscigars.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. We 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 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 Electronic Mail

cc:

sales@hilandscigars.com
hilandsales@hilandciqars.com

Dunlap, Bennett & Ludwig
tgaffney@dblawyers.com