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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Superway 7/19/12

  

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
Jul 19, 2012
 
VIA UPS
 
Superway
Attn: Site Manager
649 North 8th Street
Paducah, KY 42001
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number:12KY001285
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Superway 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 April 17, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 649 North 8th Street, Paducah, KY 42001.  During this inspection the establishment was in violation because it offered for sale individual cigarettes.   
 
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 April 17, 2012, inspection includes the following:
 
1. The establishment offered for sale individual cigarettes.  Specifically, the inspector observed the clerk on duty sell a customer two individual cigarettes. Additionally, opened packages of Basic Full Flavor and Desert Gold cigarettes containing less than 20 cigarettes were located behind the counter. 
 
A retailer must NOT sell individual cigarettes or a number of unpackaged cigarettes smaller than the minimum quantity of 20. Doing so violates 21 C.F.R. § 1140.14(d).
 
The listed violation causes your cigarettes to be “misbranded” under 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).  
 
You should immediately correct the violation listed above. Failure to correct the violations 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 12KY001285 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 Aaron Weisbuch at (301) 796-9362 or via email at Aaron.Weisbuch@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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