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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Smiley’s Lounge 4/4/13

  

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
APR 4, 2013 
VIA UPS
 
Smiley’s Lounge
Attn: Site Manager
6210 Maccorkle Avenue
St. Albans, WV 25177
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 13WV001434
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Smiley’s Lounge 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 March 25, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 6210 Maccorkle Avenue, St. Albans, WV 25177. During this inspection the establishment was in violation because it has a vending machine that sells cigarettes in a facility not restricted to adults at all times.    
 
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 March 25, 2013, inspection includes the following:
 

1. The establishment has a vending machine or other electronic or mechanical device that provides a consumer direct access to cigarettes without restricting the facility to adults at all times. 

 
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 vending machine 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. § 1140.14(c).
 
The establishment fails to ensure that minors are neither present nor permitted to enter at any time. During the inspection, the employee on duty told the inspector that minors are allowed to enter the establishment when the attached restaurant is open. 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.
 
 
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 13WV001434 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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