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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tobacco & Cigars 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
 
Tobacco & Cigars
Attn: Site Manager
720 Cottage Street
Shorewood, IL 60404                                                 
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 13IL000026AB
 
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 Tobacco & Cigars 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 January 3, 2012, and during a two-part inspection that occurred on December 10, 2012, and January 11, 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 December 10, 2012, and January 11, 2013, an inspector representing the FDA completed a two-part inspection of the establishment, located at 720 Cottage Street, Shorewood, IL 60404. During this inspection the establishment was in violation because it has a self-service display of cigarette tobacco 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 December 10, 2012, and January 11, 2013, two-part inspection includes the following:
 

1. The establishment has self-service displays or “impersonal” modes of sale that provide a consumer direct access to cigarette tobacco without restricting the facility to adults at all times. Specifically, on January 11, 2013, the inspector observed customer-accessible cigarette tobacco on the sales floor. 

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.  On January 11, 2013, the owner told the inspector that minors are allowed to enter with a parent. 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.
 
Previously, on March 1, 2012, CTP issued a Warning Letter to Tobacco & Cigars for violations observed on January 3, 2012. During this inspection the establishment was in violation because it sold tobacco to a minor and failed to check the minor’s identification. 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 and cigarette tobacco to be “misbranded” under section 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. 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 13IL000026AB 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 athttp://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf).
 
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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