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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Spanky’s Liquor World, LLC 9/27/12

  

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
SEPT 27, 2012
 
VIA UPS
 
Spanky’s Liquor World, LLC
Attn: Site Manager
1415 West US Highway 50
Pueblo, CO 81008
 
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 12CO53797 & 12CO53798
 
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 Spanky’s Liquor World 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 February 2, 2011, and during a two-part inspection that occurred on March 13, 2012. 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 March 13, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 1415 West US Highway 50, Pueblo, CO 81008. During this inspection the establishment was in violation because it has self-service displays of 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 13, 2012, inspection includes the following: 

1. The establishment has self-service displays or “impersonal” modes of sale that provide a consumer direct access to cigarettes without restricting the facility to adults at all times. Specifically, there are two displays of cigarettes located in the customer area of the store near the exits of the checkout aisles, and your clerk on duty at the time of the inspection stated that minors may enter the store if accompanied by an adult. 

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. 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.
 
Previously, on April 21, 2011, CTP issued a Warning Letter to Spanky’s Liquor World for violations observed on February 2, 2011. During this inspection the establishment was in violation because it had a self-service display of cigarettes in a facility not restricted to adults at all times. You are receiving another Warning Letter because the violations 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 violations cause your cigarettes to be “misbranded” under section 903 of the FD&C Act (21 U.S.C. § 387c).
 
You should immediately correct all violations. 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 12CO53797 & 12CO53798 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 Aaron Weisbuch at (301) 796-9362 or via email at Aaron.Weisbuch@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 
 
 
 
cc:   Spanky’s Liquor World, LLC
       2600 South Parker Road
       Suite 3-331
       Aurora, CO 80014
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