Last week’s FDA Center for Tobacco Compliance (CTP) webinar for tobacco retailers provided an overview of a new document that CTP began sending to retailers in July 2012. The document, known as a Compliance Check Inspection Notification, informs tobacco retailers that they might be receiving a violation notice in the future.
Compliance Check Inspection Notifications are sent to retailers, typically via UPS, to inform them that an underage customer (under the age of 18) successfully purchased a regulated tobacco product during an inspection. The inspections are typically conducted undercover, and retailers are typically unaware that they took place. The notifications contain, among other things, the date and approximate time that the inspection occurred.
For the most part this is a positive development, since it enables a retailer to determine which employees were on duty at the time of the alleged violation, and investigate the situation before they lose evidence about what occurred (such as surveillance tapes). The notifications also contain contact information for CTP and a summary of federal laws related to tobacco sales.
If retailers believe they have received the notification in error, they should contact the FDA immediately. After sending a retailer a notification, FDA will later determine if there was a violation, in which case the offending retailer will receive a Warning Letter, a notice that FDA is seeking a Civil Money Penalty or a notice that FDA is seeking a no-tobacco-sale order (depending on the number and severity of violations committed by the retailer).
Retailers have the opportunity to appeal civil money penalties and no-tobacco-sale orders. FDA has not yet acknowledged that retailers can appeal Warning Letters, even though they are required to permit such appeals by law. Retailers can check the results of all compliance check inspections online.
The webinar also explained that other inspections may be conducted without using minors to see if retail establishments comply with all other requirements of the law. The inspectors conducting these investigations may announce themselves when conducting investigations and issue an FDA Form 482 to the “most responsible person on duty” at the time of the inspection. Form 482 explains FDA’s authority to enter and inspect retail establishments. This form may be issued during inspections to determine if the establishment complies with requirements of the law. Form 482 does not list any observed potential violations, and a retailer is not required to do anything with this form. (NACS: www.nacsonline.com)
