• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Rusty Nail 8/30/12

  

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
Aug 30, 2012
 
VIA UPS
 
Rusty Nail
Attn: Site Manager
307 Main Avenue North
Thief River Falls, MN 56701
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 12MN000753
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Rusty Nail 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 17, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 307 Main Avenue North, Thief River Falls, MN  56701. 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 false and/or misleading buttons 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 17, 2012, inspection include the following:
 
1. The establishment has a vending machine 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. During the inspection, the owner told the inspector that minors are allowed to enter the establishment with an adult on Saturdays from 11:00 AM until 2:00 PM. 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.
 
2. The establishment has a vending machine with selection buttons marked “Low in Tar and Nicotine Marlboro Lights,” “Marlboro Lights Flip-Top Box,” “Marlboro Lights 100’s,” “Marlboro Ultra Lights Flip-Top Box,” “Winston Lights Box” and “Camel Lights.” The cigarettes stocked to correspond with the “Low in Tar and Nicotine Marlboro Lights,” “Marlboro Lights Flip-Top Box,” “Marlboro Lights 100’s,” “Marlboro Ultra Lights Flip-Top Box,” “Winston Lights Box” and “Camel Lights” buttons 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 buttons use the term “low tar” or “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 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 12MN000753 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 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
 
 
Return to Tobacco Retailer Warning Letters Main Page