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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Texas Wholesale - Close Out Letter 11/24/09

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229

 

 

November 24, 2009

 

Mr. Mohammad H. Wazirali (Mike Wazir), Partner
Texas Wholesale (Sakom Investment, Ltd.)
11409 Denton Drive
Dallas, TX 75229

 

Dear Mr. Wazir:

We acknowledge receipt of your response to the November 3, 2009 Warning Letter issued by FDA's Center for Tobacco Products. We have reviewed the corrections that you have made to your website relating to your marketing and sale of the following flavored cigarettes in the United States: Djarum Bali Hai Natural Clove Box, Djarum Black Kretek Clove 10 Count Box, Djarum Cherry, Djarum Splash Clove 10 Count Box, Djarum Vanilla Filter Kretek 10 Count Box, Dreams Assorted Flavors 5 Pack Box, Dreams Cherry Filter 5 Pack Box, Dreams Chocolate Mocha Filter 5 Pack Box, Dreams Natural Vanilla 5 Pack Box, Dreams Vanilla Filter 5 Count Box, Zanzibar Chardonnay Clove Cigarettes, 10 count, Zanzibar Cherry Clove Cigarettes, 10 count, Zanzibar Crossfire Clove Cigarettes, 10 count, Zanzibar Lights Clove Cigarettes, 10 count, Zanzibar Ultimate Clove Cigarettes, 10 count, Zanzibar Vanilla Clove Cigarettes, 10 count, Zanzibar Xtreme Clove Cigarettes, 10 count, Zanzibar Zanzilatte Cafe Latte Clove Cigarettes, 10 count, and Zanzibar Zanzitwist Citrus Clove Cigarettes, 10 count. Your corrective actions appear to adequately address the concerns detailed in the Warning Letter. We will periodically monitor your web site to ensure your continued compliance. You are reminded that it is your obligation to ensure that the tobacco products that you market and sell on your Web site to consumers in the United States comply with the Federal, Food, Drug & Cosmetic Act.

Sincerely, 

/s/


Ann Simoneau
Regulatory Counsel
Center for Tobacco Products