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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Scooter's Express Gas & Grocery 8/29/13

  

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 29 2013
VIA UPS
 
Scooter’s Express Gas & Grocery
Attn: Site Manager
13022 State Highway 76
Forsyth, MO 65653
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 13MO001059AB
 
Dear Sir or Madam:
 
This Warning Letter is notification from the Center for Tobacco Products (CTP), United States Food and Drug Administration (FDA), advising you that Scooter’s Express Gas & Grocery was observed to be in violation of federal tobacco laws and regulations. Violations of 21 C.F.R 1140 were observed during an inspection that occurred on March 8, 2012, and during a two-part inspection that occurred on June 3 and 10, 2013. Please be advised that additional violations observed during any subsequent inspection may lead to a Civil Money Penalty (CMP), according to the schedule provided later in this document, and/or a No-Tobacco-Sale Order. Your response is requested in 15 working days.
 
On June 3 and 10, 2013, an inspector representing the FDA completed a two-part inspection of the establishment, located at 13022 State Highway 76, Forsyth, MO 65653. During this inspection the establishment was in violation because you or your employee sold smokeless tobacco to a minor.  
 
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 June 3 and 10, 2013, two-part inspection includes the following: 

1.  A minor was able to buy Red Seal Long Cut Wintergreen smokeless tobacco on June 3, 2013, at approximately 2:48 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).
 
Previously, on May 3, 2012, CTP issued a Warning Letter to Scooter’s Express Gas & Grocery for violations observed on March 8, 2012. During this inspection the establishment was in violation because it had a self-service display of smokeless tobacco in a facility not restricted to adults at all times. You are receiving another Warning Letter because the violation observed during your most recent inspection occurred outside the statutory period for FDA to seek a CMP at this time. Please be advised that additional violations observed during any subsequent inspection may lead to a CMP, according to the schedule provided later in this document, and/or a No-Tobacco-Sale Order.
 
The listed violation causes your smokeless tobacco to be “misbranded” under section 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 13MO001059AB 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

The CMP schedule is as follows: 

Number of Violations
Civil Money Penalty
First
$0.00 w/ warning letter
Second within a 12 month period
$250
Third within a 24 month period
$500
Fourth within a 24 month period
$2,000
Fifth within a 36 month period
$5,000
Sixth within a 48 month period
$10,000

  

See 21 C.F.R. § 17.2; Guidance for FDA and Tobacco Retailers, Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers, March 2011 (available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf).
 
If you have any questions, contact Ms. Sashka Mannion at (301) 796-3010 or via email at Sashka.Mannion@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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