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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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F.K. Kirsten Ltd. 12/13/12


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 


DEC 13, 2012 
F.K. Kirsten Ltd.
Attn: Site Manager
1900 West Nickerson Street, Suite 112
Seattle, WA 98119
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number:  12WA004597
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that F.K. Kirsten Ltd. was observed to be in violation of federal tobacco laws and regulations. Failure to correct these violations may lead to federal enforcement actions, including monetary penalties. Your response is requested in 15 working days.
On September 5, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 1900 West Nickerson Street, Suite 112, Seattle, WA 98119. During this inspection, the establishment was in violation of federal law because it distributed free samples of smokeless tobacco in a location that is not a qualified adult-only facility.    
This inspection revealed that the establishment sells, distributes, advertises, and/or promotes cigarettes, cigarette tobacco, and/or smokeless tobacco, which requires that the establishment and its owners comply with federal laws and regulations governing such practices. The violation observed during the September 5, 2012, inspection includes the following:
1. The establishment distributed free samples of General smokeless tobacco, and is not a qualified adult-only facility.
A retailer must NOT distribute free samples of smokeless tobacco unless it is a qualified adult-only facility. Doing so violates 21 C.F.R. §1140.16(d)(1).
A retailer may only distribute free samples of smokeless tobacco in a facility that meets the requirements for a qualified adult-only facility, as listed in 21 C.F.R. § 1140.16(d)(2)(iii). The establishment does not meet the requirements because it is not a temporary structure constructed, designated, and operated as a distinct enclosed area for the purpose of distributing free samples of smokeless tobacco.
The listed violation causes your smokeless tobacco to be “misbranded” under 903 of the FD&C Act (21 U.S.C. § 387c).
You should immediately correct the violation listed above. Failure to correct the violation may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction.
The violation indicated in this letter may not be a complete list of violations at the establishment. The establishment must comply with all the applicable laws and regulations. For more information on these requirements, helpful resources for retailers, a database of inspections, and free Break the Chain of Tobacco Addiction materials, visit our website at http://www.fda.gov/TobaccoProducts.    
You have 15 working days from the date you receive this letter to respond. In your response, explain your plan for correcting the listed violation and preventing future violations. Include a telephone number and address. Note your reference number of 12WA004597 in your response and mail it to:
SP-WL Response
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
If you have any questions, contact Carisa Bergen at (301) 796-2990 or via email at Carisa.Bergen@fda.hhs.gov. Have your reference number ready when you call and include it with any email communications.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
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