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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sunny Food Mart 9/26/13

  

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
September 26 2013
 
VIA UPS
 
Sunny Food Mart
Attn: Site Manager
600 Ward Boulevard
Wilson, NC 27893
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 13NC001655
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Sunny Food Mart 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 28, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 600 Ward Boulevard, Wilson, NC 27893. During this inspection the establishment was in violation because it offered for sale individual cigarettes and also packages with fewer than 20 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 violations observed during the July 28, 2013, inspection include the following: 

1.  The establishment offered for sale individual cigarettes. Specifically, the cashier on duty told the inspector that the establishment sells three individual cigarettes for $1.00. 

A retailer must NOT sell individual cigarettes. Doing so violates 21 C.F.R. § 1140.14(d).
 
2.  The establishment offered for sale a package with fewer than 20 cigarettes. Specifically, the inspector observed the cashier on duty sell to a customer a package of Newport cigarettes that contained 6 cigarettes.
 
A retailer must NOT sell a package that contains fewer than 20 cigarettes. Doing so violates 21 C.F.R. § 1140.16(b).
 
The listed violations cause your cigarettes to be “misbranded” under 903 of the FD&C Act (21 U.S.C. § 387c). 
 
You should immediately correct the violations 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 violations 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 violations and preventing future violations. Include a telephone number and address. Note your reference number of 13NC001655 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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