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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sir Scott's Oasis 5/23/13

  

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
May 23, 2013 
VIA UPS
 
Sir Scott’s Oasis
Attn: Site Manager
204 West Main Street
Manhattan, MT 59741
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 13MT000331
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Sir Scott’s Oasis 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 May 4, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 204 West Main Street, Manhattan, MT 59741. During this inspection the establishment was in violation because it has a vending machine that sells cigarettes in a facility not restricted to adults at all times and the vending machine has a false and/or misleading button marked “low tar” or “light”.     
 
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 May 4, 2013, inspection include the following:
 
  1. The establishment has a vending machine or other electronic or mechanical device that provides a consumer direct access to cigarettes without restricting the facility to adults at all times.   
 
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 vending machine 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. § 1140.14(c).
 
The establishment fails to ensure that minors are neither present nor permitted to enter at any time as the establishment is open to the general public during business hours.  Therefore, the establishment is not restricted.  The lockout device on the vending machine is insufficient to meet the requirements of the law. 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.
 
  1. The establishment has a vending machine with a selection button marked “Marlboro Lights.” The cigarettes stocked to correspond with the “Marlboro Lights” button are not labeled as such. Cigarettes, cigarette tobacco, and/or smokeless tobacco with labels, labeling, or advertising that do not correspond to the actual product are misbranded under section 903 of the FD&C Act (21 U.S.C. § 387c), in that the name on the button is false and/or misleading. In addition, the button uses the term “light.” Cigarettes with labels, labeling, or advertising that use the descriptor “low tar” or “light” are misbranded under section 903 of the FD&C Act (21 U.S.C. § 387c), in that the descriptive terms are false and/or misleading. Labeling or advertising cigarettes as “low tar” or “light” is misleading to consumers. Congress has found many smokers mistakenly believe that “low tar” and “light” cigarettes cause fewer health problems than other cigarettes.
 
A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco for which the label, labeling, or advertising is false and/or misleading. Doing so is prohibited by section 301 of the FD&C Act (21 U.S.C. § 331).
 
The listed violations cause your cigarettesto 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 13MT000331 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 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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