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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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North End Tavern 7/17/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

 

WARNING LETTER
July 17 2014
 
VIA UPS
 
North End Tavern
Attn: Site Manager
308 North Main Street
De Soto, MO 63020
                                                                                                                                                       
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 14MO002820
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that North End Tavern 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 14, 2014, an inspector representing the FDA completed an inspection of the establishment, located at 308 North Main Street, De Soto, MO 63020. During this inspection the establishment was in violation because it has a vending machine with false and/or misleading buttons marked “low tar” or “light.”    
 
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 May 14, 2014, inspection includes the following: 

1.  The establishment has a vending machine with selection buttons marked “Marlboro Lights 100’s,” “Marlboro Medium,” “Marlboro Ultra Lights,” and “Camel Lights.”  The cigarettes stocked to correspond with the “Marlboro Lights 100’s,” “Marlboro Medium,” “Marlboro Ultra Lights,” and “Camel Lights” buttons are not labeled as such. Cigarettes, cigarette tobacco, and/or smokeless tobacco with labels, labeling, or advertising that do not correspond to the actual product are misbranded under section 903 of the FD&C Act (21 U.S.C. § 387c), in that the name on the button is false and/or misleading. In addition, the buttons use the term “light.” Cigarettes with labels, labeling, or advertising that use the descriptor “low tar” or “light” are misbranded under section 903 of the FD&C Act (21 U.S.C. § 387c), in that the descriptive terms are false and/or misleading. Labeling or advertising cigarettes as “low tar” or “light” is misleading to consumers. Congress has found many smokers mistakenly believe that “low tar” and “light” cigarettes cause fewer health problems than other cigarettes. 

A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco for which the label, labeling, or advertising is false and/or misleading. Doing so is prohibited by section 301 of the FD&C Act (21 U.S.C. § 331). 
 
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 14MO002820 in your response and mail it to:
 
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD  20993-0002
 
If you have any questions, contact the Center for Tobacco Products at 1-877-CTP-1373, option 6, 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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