Inspections, Compliance, Enforcement, and Criminal Investigations
Freedom Valu Center #14 12/12/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229
December 12, 2013
Freedom Valu Center #14
Attn: Site Manager
407 East Blue Earth Avenue
Fairmont, MN 56031
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
Reference Number: 13MN002873AB
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 Freedom Valu Center #14 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 April 30, 2012, and during a two-part inspection that occurred on August 14 and 26, 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 August 14 and 26, 2013, an inspector representing the FDA completed a two-part inspection of the establishment, located at 407 East Blue Earth Avenue, Fairmont, MN 56031. During this inspection the establishment was in violation because it has self-service displays of cigarettes and smokeless 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 August 14 and 26, 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 cigarettes and smokeless tobacco without restricting the facility to adults at all times. Specifically, on August 26, 2013, the inspector observed three unlocked display cases on the main sales floor of the establishment containing cigarettes and smokeless tobacco.
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 as the establishment is open to the general public during business hours. 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 July 26, 2012, CTP issued a Warning Letter to Freedom Valu Center #14 for a violation observed on April 30, 2012. During that inspection the establishment was in violation because it had a self-service display of smokeless tobacco in a facility not restricted to adults at all times. You are receiving another Warning Letter because the violation 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 violation causes your cigarettes and smokeless tobacco to be “misbranded” under section 903 of the FD&C Act (21 U.S.C. § 387c).
You should immediately correct the violation listed above. Failure to correct the violation 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 violation 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 violation and preventing future violations. Include a telephone number and address. Note your reference number of 13MN002873AB in your response and mail it to:
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
$0.00 w/ warning letter
Second within a 12 month period
Third within a 24 month period
Fourth within a 24 month period
Fifth within a 36 month period
Sixth within a 48 month period
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 at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf).
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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products