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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ellis Avenue Food Mart 6/12/14

  

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
June 12, 2014 
VIA UPS
 
Ellis Avenue Food Mart
Attn: Site Manager
1100 North Ellis Avenue
Dunn, NC 28334
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 14NC001816
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Ellis Avenue 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 April 7, 2014, an inspector representing the FDA completed an inspection of the establishment, located at 1100 North Ellis Avenue, Dunn, NC 28334. During this inspection the establishment was in violation because it offered individual cigarettes for sale.
 
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 7, 2014, inspection includes the following: 

1. The establishment offered for sale individual cigarettes. Specifically, the inspector observed a Swisher Sweets cigarillo box containing single cigarettes. When asked about these cigarettes, the owner told the inspector that the establishment sells 2 individual cigarettes for $1.00.   

A retailer must NOT sell individual cigarettes. 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.
 
We will periodically inspect your establishment and review your promotional activities (e.g., website{s}) related to FDA-regulated tobacco products to assess your compliance with all applicable laws and regulations, including access, marketing, labeling, and advertising restrictions. 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. Specifically, Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents provides additional information on compliance with retailer responsibilities http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm252758.htm.
 
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 14NC001816 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 CTP at 1-877-CTP-1373, option 1, or via email at CTP-Compliance-WL-Correspondence@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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