• 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

Discount Tobacco 6/26/14


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Center for Tobacco Products
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 


June 26 2014
Discount Tobacco    
Attn: Site Manager
1726 East Sangamon Avenue
Springfield, IL 62702                                             
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 14IL001013
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Discount Tobacco 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 March 31, 2014, an inspector representing the FDA completed an inspection of the establishment, located at 1726 East Sangamon Avenue, Springfield, IL 62702. During this inspection the establishment was in violation because it distributed free samples of cigarette tobacco.
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 March 31, 2014, inspection includes the following:
1.  The establishment distributed free samples of cigarette tobacco. Specifically, the investigator observed a table in the store with materials to make cigarettes, including open bags of cigarette tobacco, papers, and a cigarette making machine. A hand-written sign on the table stated: “This is a display for customers wanting to try RYO cigs! Please only 1 cig when trying this. They are not to come and get free cigs!” When asked about it, the cashier on duty told the inspector that if a customer is new to rolling their own cigarettes or wants to try a different tobacco, the customer is allowed to roll one cigarette and try it for free.
A retailer must NOT distribute free samples of cigarette tobacco. Doing so violates 21 C.F.R. § 1140.16(d)(1).
The listed violation causes your cigarette 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.
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 violation and preventing future violations.  Include a telephone number and address. Note your reference number of 14IL001013 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 at 1-877-CTP-1373, option 6, or via email at CTP-Compliance-WL-Correspondence@fda.hhs.gov. Have your reference number ready when you call and include it with any email communications.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
Return to Tobacco Retailer Warning Letters Main Page