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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Smokies Cigarette Outlet 9/27/12

  

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

SEP 27, 2012

VIA UPS

Smokies Cigarette Outlet
Attn: Site Manager
3669 Montgomery Highway
Dothan, AL  36303

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 12AL001061

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Smokies Cigarette Outlet 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 June 11, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 3669 Montgomery Highway, Dothan, AL  36303. During this inspection the establishment was in violation because it has self-service displays of cigarette tobacco 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 June 11, 2012, inspection includes the following:

1. The establishment has self-service displays or “impersonal” modes of sale that provide a consumer direct access to cigarette tobacco and smokeless tobacco without restricting the facility to adults at all times.  Specifically, the inspector observed a display containing multiple brands of smokeless tobacco near the entrance, a display of Skoal smokeless tobacco on a counter and multiple brands of cigarette tobacco and smokeless tobacco in customer accessible areas on the sales floor.

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.

The listed violation causes your cigarette tobacco and smokeless tobacco to be “misbranded” under 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 12AL001061 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 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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