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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Red Bay Food Mart, Inc. d/b/a Food Mart 12/15/11

  

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
 
VIA UPS
 
DEC 15 2011
 
Red Bay Food Mart, Inc.
d/b/a Food Mart
Attn: Site Manager
211 4th Avenue Southwest
Red Bay, AL 35582
 
Re: Reference Number: 11AL37670
 
Dear Sir or Madam:
 
On September 2, 2011, an inspector representing the United States Food and Drug Administration (FDA) completed a compliance check inspection of your establishment located at 211 4th Avenue Southwest, Red Bay, AL 35582. Your establishment sells cigarettes and/or smokeless tobacco products. The sale, distribution, advertising, and promotion of your tobacco products must comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, found at Title 21, Code of Federal Regulations (C.F.R.), Part 1140. You are legally responsible for complying with these regulations and for ensuring that your employees comply with these regulations. 
 
This compliance check inspection revealed that your tobacco products are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act, 21 U.S.C. § 387c(a)(7)(B), in that they are sold or distributed in violation of 21 C.F.R. Part 1140. The violations identified at your establishment include, but are not limited to, the following:
 

1. Sale of cigarettes or smokeless tobacco to a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(a).

 
For example, you or one of your employees sold a package of Pall Mall Menthol cigarettes to a minor on September 2, 2011.
    

2. Failure to verify by means of photographic identification, containing the bearer’s date of birth, that no person purchasing cigarettes or smokeless tobacco is younger than 18 years of age, as required by 21 C.F.R. § 1140.14(b)(1). No such verification is required for any person over the age of 26, as per 21 C.F.R. § 1140.14(b)(2).

 
For example, you or one of your employees sold a package of Pall Mall Menthol cigarettes to a minor on September 2, 2011, and failed to verify by means of photographic identification that the minor was 18 years of age or older.
 
You should immediately correct the violation(s) by ceasing the violative marketing, sale, and/or distribution of tobacco products to consumers at your establishment. Failure to correct the violation(s) may result in regulatory action being initiated by the FDA without further notice. These actions may include, but are not limited to, a civil money penalty, no-tobacco-sale order, seizure, and/or injunction.
 
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request and explaining your plan for discontinuing the violative marketing, sale, and/or distribution of your tobacco products. As part of your response, please include a phone number and an email address at which we may contact you and make note of any discrepancies in the contact information related to your business or corporate entity.
 
Your response should specify the reference number identified at the beginning of the letter and be addressed to:
 
SP-WL Response
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland  20850
 
The violation(s) discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your tobacco products comply with the applicable provisions of the FD&C Act, as amended by the Tobacco Control Act and applicable regulations.
 
If you have any questions about the content of this letter, please contact Jeff Shiffman at (301) 796-3091 or via email at jeffrey.shiffman@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

 

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