Inspections, Compliance, Enforcement, and Criminal Investigations

Fred’s 2/1/18

 

  

Black HHS-Blue FDA Logo

 

 

 
U.S. Food & Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

WARNING LETTER
February 1 2018
 
VIA UPS
 
Fred’s
Attn: Site Manager
1150 North Jefferson Street
Monticello, FL 32344
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation 
       Reference Number: 17FL012697AB
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Fred’s 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 9 and 15, 2018, an inspector representing the FDA completed a two-part inspection of the establishment, located at 1150 North Jefferson Street, Monticello, FL 32344. During this inspection the establishment was in violation because you or your employee sold cigars to a minor.
 
This inspection revealed that the establishment sells, distributes, and/or advertises tobacco products, including cigars, which requires that the establishment and its owners comply with federal laws and regulations governing such practices. The violation observed during the January 9 and 15, 2018, two-part inspection includes the following:
 
1.      A minor was able to buy Swisher Sweets cigars on January 9, 2018, at approximately 3:45 PM in the establishment.

A retailer must NOT sell covered tobacco products, such as cigars, to a person younger than 18 years of age. Doing so violates 21 C.F.R. § 1140.14(b)(1) (2016).
 
The listed violation causes your cigars 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.
 
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. 
 
Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the Act. These products include, but are not limited to, electronic nicotine delivery systems (including e-cigarettes), e-liquids, cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.
 
For more information on these requirements, helpful resources for retailers, a database of inspections, and retailer education materials, visit our website at http://www.fda.gov/TobaccoProducts. The following Guidance documents provide additional information on compliance with retailer responsibilities: 
 
Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents (http://www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatoryInformation/ucm252758.htm)
 
Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (http://www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ucm499353.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 violation and preventing future violations. Include a telephone number and address. Note your reference number of 17FL012697AB in your response and mail it to:
 
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 
If you have any questions, contact the Center for Tobacco Products via email at CTP-WL@fda.hhs.gov or via phone at 1-877-CTP-1373, option 6. 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
 
 
 
cc:          Fred’s, Inc.
               Attn: Legal Department
               4300 New Getwell Road
               Memphis, TN 38118
 
 
 

Page Last Updated: 03/08/2018
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