• 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

Ensley Seafood #2

  

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
OCT 11 2012 
VIA UPS
 
Ensley Seafood #2
Attn: Site Manager
6805 1st Avenue North
Birmingham, AL 35206
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 12AL002388
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Ensley Seafood #2 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 25, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 6805 1st Avenue North, Birmingham, AL 35206. During this inspection the establishment was in violation because it offered unpackaged cigarettes for sale in a quantity smaller than 20 and it offered packages with fewer than 20 cigarettes for sale.    
 
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 June 25, 2012,inspection include the following:
 
1. The establishment offered for sale a number of unpackaged cigarettes smaller than the minimum quantity of 20. Specifically, the inspector observed unpackaged individual cigarettes behind the counter and the inspector witnessed the sale of unpackaged individual cigarettes during the inspection.  
 
A retailer must NOT sell a number of unpackaged cigarettes smaller than the minimum quantity of 20 cigarettes.  Doing so violates 21 C.F.R. § 1140.14(d).
 
2. The establishment offered for sale a package of cigarettes which contained three cigarettes. Specifically, the inspector observed a customer purchase three cigarettes wrapped together in a single package.
 
A retailer must NOT sell a package that contains fewer than 20 cigarettes. Doing so violates 21 C.F.R. § 1140.16(b).
 
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 12AL002388 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 atAaron.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