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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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LA Smoke Shop 3/21/13

  

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
MAR 21, 2013
 
VIA UPS
 
LA Smoke Shop
Attn: Site Manager
7241 West 3500 South
Magna, UT 84044
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 13UT000061AB
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that LA Smoke Shop 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 December 4 and 13, 2012, an inspector representing the FDA completed a two-part inspection of the establishment, located at 7241 West 3500 South, Magna, UT 84044. During this inspection the establishment was in violation because you or your employee sold cigarettes to a minor and because the establishment has a self-service display 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 violations observed during the December 4 and 13, 2012,two-part inspection include the following: 

1.      A minor was able to buy Marlboro cigarettes on December 4, 2012, at approximately 5:29 PM MT 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.      The establishment has a self-service display or an “impersonal” mode of sale that provides a consumer direct access to cigarettes without restricting the facility to adults at all times. Specifically, on December 13, 2012, the inspector observed discount cigarettes in a customer-accessible bin on the checkout counter.

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.  During the inspection, the clerk on duty told the inspector that minors are allowed to enter with an adult. 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.
 
The listed violations cause your cigarettes 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. 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 13UT000061AB 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
 
 
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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