Inspections, Compliance, Enforcement, and Criminal Investigations
Agricola Quick Stop 8/2/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229
Aug 2, 2012
Agricola Quick Stop
Attn: Site Manager
6197 Highway 613
Lucedale, MS 39452
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
Reference Number: 12MS58281 & 12MS58282
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Agricola Quick Stop 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 11 and February 9, 2012, an inspector representing the FDA completed a two-part inspection of the establishment, located at 6197 Highway 613, Lucedale, MS 39452. During this inspection the establishment was in violation because it has a self-service display of cigarettes in a facility not restricted to adults at all times, you or your employee sold cigarettes to a minor and failed to check identification to verify purchaser’s age.
Please note that you are receiving this Warning Letter because the violations observed during the January 11 and February 9, 2012,two-part inspection occurred under the ownership of CVM, LLC, which FDA has recently learned is a new owner of this establishment, having taken ownership from Agricola Quick Stop LLC. FDA had previously notified Agricola Quick Stop LLC of these violations and was directed to CVM, LLC. During telephone conversations on July 9 and 17, 2012, Mr. Mike Welford, officer of CVM, LLC, stated that CVM, LLC is the current owner, and was the owner of this establishment at the time of the two-part compliance inspection.
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 January 11 and February 9, 2012, two-part inspection include the following:
1. A minor was able to buy Newport Box cigarettes on January 11, 2012, at approximately 5:36 PM CT.
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).
2. No one in the establishment checked the minor’s identification before the sale of Newport Box cigarettes on January 11, 2012, at approximately 5:36 PM CT.
A retailer MUST check a photographic identification that includes a date of birth for any person under the age of 27 who attempts to purchase cigarettes, cigarette tobacco, and/or smokeless tobacco. Failure to do so violates 21 C.F.R. § 1140.14(b)(1).
3. The establishment has a self-service display that provides a consumer direct access to cigarettes without restricting the facility to adults at all times. Specifically,the inspector documented a self-service display of discount cigarettes on the counter, in a clear, plastic container, which is accessible to customers.
A retailer MUST sell cigarettes, cigarette tobacco, and/or smokeless tobacco only in a direct, face-to-face exchange between the retailer and the consumer and cannot use a self-service display unless a retailer ensures that minors are neither present nor permitted to enter at any time. Failure to do so violates 21 C.F.R. § 1140.16(c).
The establishment fails to ensure that minors are neither present nor permitted to enter at any time because the establishment operates as a convenience store that is open to the general public. Therefore, the establishment is not restricted.It is your responsibility to ensure that no person younger than 18 years of age is present or permitted to enter the establishment at any time, or to ensure that all cigarettes, cigarette tobacco, and/or smokeless tobacco products are only sold in a direct, face-to-face exchange.
The listed violations cause 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 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 12MS58281 & 12MS58282 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 Ms. Sashka Mannion at (301) 796-3010 or via email at Sashka.Mannion@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