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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Winn’s Express 8/22/13

  

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
August 22, 2013 
VIA UPS
 
Winn’s Express
Attn: Site Manager
1050 Old Lenoir Road
Hickory, NC 28601
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 13NC000705
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Winn’s Express 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 May 30, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 1050 Old Lenoir Road, Hickory, NC 28601. During this inspection the establishment was in violation because it has a self-service display of smokeless tobacco in a facility not restricted to adults at all times and because it distributed free samples of 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 May 30, 2013, inspection include the following:
 
1. The establishment has a self-service display or an “impersonal” mode of sale that provides a consumer direct access to smokeless tobacco without restricting the facility to adults at all times. Specifically, the inspector observed stacks of Red Man smokeless tobacco for sale from a self-service display in a customer-accessible part of the checkout counter.
 
A retailer MUST sell cigarettes, cigarette tobacco, and/or smokeless tobacco only in a direct, face-to-face exchange between the retailer and the consumer and cannot use a self-service display unless a retailer ensures that minors are neither present nor permitted to enter at any time. Failure to do so violates 21 C.F.R. § 1140.16(c).
The establishment fails to ensure that minors are neither present nor permitted to enter at any time as the establishment is open to the general public during business hours. Therefore, the establishment is not restricted. It is your responsibility to ensure that no person younger than 18 years of age is present or permitted to enter the establishment at any time, or to ensure that all cigarettes, cigarette tobacco, and/or smokeless tobacco products are only sold in a direct, face-to-face exchange.
 
2. The establishment distributed free samples of cigarettes.  Specifically, the inspector observed opened packs of Marlboro Southern Cut and King Mountain Menthol 100’s cigarettes behind the counter. When asked about the opened packages, the store manager stated that he gives cigarettes away for free to his customers to allow them to sample the product.
 
A retailer must NOT distribute free samples of cigarettes. Doing so violates 21 C.F.R. § 1140.16(d)(1).
 
The listed violations cause your smokeless tobacco and 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 13NC000705 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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