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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mifflinburg Shell 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
 
Mifflinburg Shell
Attn: Site Manager
29 Chestnut Street
Mifflinburg, PA 17844                                                   
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 14PA004930
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Mifflinburg Shell 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 June 11, 2014, an inspector representing the FDA completed an inspection of the establishment, located at 29 Chestnut Street, Mifflinburg, PA 17844. During this inspection the establishment was in violation because you or your employee sold smokeless tobacco to a minor and failed to check identification to verify purchaser’s age.
 
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 June 11, 2014, inspection include the following: 

1.  A minor was able to buy Copenhagen Long Cut Wintergreen smokeless tobacco on June 11, 2014, at approximately 5:31 PM in the establishment.  

A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco to a person younger than 18 years of age. Doing so violates 21 C.F.R. § 1140.14(a).
    

2.  No one in the establishment checked the minor’s identification before the sale of Copenhagen Long Cut Wintergreen smokeless tobacco on June 11, 2014, at approximately 5:31 PM. 

A retailer MUST check a photographic identification that includes a date of birth for any person under the age of 27 who attempts to purchase cigarettes, cigarette tobacco, and/or smokeless tobacco. Failure to do so violates 21 C.F.R. § 1140.14(b)(1).
 
The listed violations cause your smokeless tobacco 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.
 
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 violations and preventing future violations. Include a telephone number and address. Note your reference number of 14PA004930 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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