Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
JUL 12, 2012
Attn: Site Manager
47720 US Highway 78
Lincoln, AL 35096
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
Reference Number: 12AL000388
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Shell 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 April 14, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 47720 US Highway 78, Lincoln, AL 35096. During this inspection the establishment was in violation because you or your employee sold cigarettes to a minor.
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 April 14, 2012, inspection includes the following:
1. A minor was able to buy Newport Box cigarettes on April 14, 2012, at approximately 2:03 PM CT 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).
The listed violation causes your cigarettes to be “misbranded” under 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
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. 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 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 violation and preventing future violations. Include a telephone number and address. Note your reference number of 12AL000388 in your response and mail it to:
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
If you have any questions, contact Carisa Bergen at (301) 796-2990 or via email at Carisa.Bergen@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