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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mike's/Sinclair 9/20/12

  

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

WARNING LETTER

SEP 20, 2012

VIA UPS

Mike's/Sinclair
Attn: Site Manager
600 West Highway 24
Salisbury, MO  65281

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violation 
       Reference Number:  12MO001922

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Mike’s/Sinclair 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 July 12, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 600 West Highway 24, Salisbury, MO  65281.  During this inspection the establishment was in violation because you or your employee sold smokeless tobacco to a minor.

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 July 12, 2012, inspection includes the following:

1. A minor was able to buy Timber Wolf Long Cut Wintergreen smokeless tobacco on July 12, 2012, at approximately 10:33 AM CT in the establishment.

A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco to a person younger than 18 years of age.  Doing so violates 21 C.F.R. § 1140.14(a).

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 12MO001922 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. 

Sincerely,

/S/

Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products


 

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