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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pizza Villa 8/23/12

  

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 23, 2012
 
VIA UPS
 
Pizza Villa
Attn: Site Manager
940 Congress Street
Portland, ME 04102
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number:  12ME56753
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Pizza Villa 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 April 14, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 940 Congress Street, Portland, ME 04102. 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 in Tar and Nicotine Marlboro Lights.”
 
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 April 14, 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, an employee on duty told the inspector that minors are allowed to enter with an adult prior to 9:00 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 a selection button marked “Low in Tar and Nicotine Marlboro Lights.” The cigarettes stocked to correspond with the “Low in Tar and Nicotine 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 describes the cigarettes as “low in tar” and “light”. Cigarettes with labels, labeling, or advertising that use the descriptors “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 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.
 
Additionally, the establishment has a vending machine with a selection button marked “Parliament Lights.” Cigarettes, cigarette tobacco, and/or smokeless tobacco with labels, labeling, or advertising that do not match the corresponding 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.
 
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). However, retailers are allowed to sell products marked “low,” “light,” or “mild” by the manufacturer if the product was manufactured before June 22, 2010, and distributed by the manufacturer before July 22, 2010. If the products do not meet those criteria, they are not covered by the limited exception described above. Therefore, if the package from the manufacturer does not say “Parliament Lights,” your vending machine selection button cannot say “Parliament Lights.”
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 12ME56753 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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