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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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H.J. Bailey Co - 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


Ms. Elise Feliner Roth, Attorney At Law
119 Bond Drive
Morganville, NJ 07751


RE: H.J. Bailey Company


Dear Ms. Roth:

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 Hai20S, Djarum Filter 20S, Djarum Black 20S. 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 

 

cc: Allen S. Roth, Finance Executive
H.J. Bailey Company
1105 Green Grove Rd.
Neptune, NJ 07753-2517