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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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First & Last Chance 3/20/14

  

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
March 20, 2014 
VIA UPS
 
First & Last Chance
Attn: Site Manager
11810 Maybelline Road
North Little Rock, AR 72117
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 14AR001038
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that First & Last Chance 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 January 3, 2014, an inspector representing the FDA completed an inspection of the establishment, located at 11810 Maybelline Road, North Little Rock, AR 72117. During this inspection the establishment was in violation because you or your employee sold smokeless tobacco to a minor and failed to check identification to verify purchaser’s age, and because the establishment has a self-service display of 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 violations observed during the January 3, 2014, inspection include the following: 

1. A minor was able to buy Red Seal Fine Cut Wintergreen smokeless tobacco on January 3, 2014, at approximately 11:59 AM in the establishment.  

A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco to a person younger than 18 years of age. Doing so violates 21 C.F.R. § 1140.14(a).    

2. No one in the establishment checked the minor’s identification before the sale of Red Seal Fine Cut Wintergreen smokeless tobacco on January 3, 2014, at approximately 11:59 AM. 

A retailer MUST check a photographic identification that includes a date of birth for any person under the age of 27 who attempts to purchase cigarettes, cigarette tobacco, and/or smokeless tobacco. Failure to do so violates 21 C.F.R. § 1140.14(b)(1).
 
3. The establishment has a self-service display or an “impersonal” mode of sale that provides a consumer direct access to smokeless tobacco without restricting the facility to adults at all times. Specifically, a minor entered the establishment and purchased smokeless tobacco obtained from the self-service display.
 
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.  During the inspection, a minor was able to enter the establishment and purchase smokeless tobacco.  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 violations cause your smokeless tobacco 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.
 
We will periodically inspect your establishment and review your promotional activities (e.g., website{s}) related to FDA-regulated tobacco products to assess your compliance with all applicable laws and regulations, including access, marketing, labeling, and advertising restrictions. 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. Specifically, Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents provides additional information on compliance with retailer responsibilities http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm252758.htm.
 
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 14AR001038 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
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