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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Save-N-Save Supermarket 9/13/12

  

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

WARNING LETTER

SEP 13, 2012

VIA UPS

Save-N-Save Supermarket
Attn: Site Manager
3394 Macon Road
Memphis, TN  38122

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violation 
       Reference Number:  12TN001133

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Save-N-Save Supermarket 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 June 7, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 3394 Macon Road, Memphis, TN  38122.  During this inspection the establishment was in violation because it offered unpackaged cigarettes for sale in a quantity smaller than 20.

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 June 7, 2012, inspection includes the following:

1. The establishment offered for sale a number of unpackaged cigarettes smaller than the minimum quantity of 20.  Specifically, the inspector observed the clerk sell three loose cigarettes to a customer for $1.00.

A retailer must NOT sell 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 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 12TN001133 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 Ms. Sashka Mannion at (301) 796-3010 or via email at Sashka.Mannion@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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