When a retailer receives a first-time tobacco compliance check that results in a violation, the FDA will issue a warning letter to the retailer detailing the violation. That letter will include:
— References to relevant laws and regulations.
— The date the store was inspected. If a sale was made, the approximate time will also be noted.
— The violation(s) inspectors observed and an explanation of the evidence used to support the violation(s).
— A statement directing the retailer to correct the violation(s).
— Notice that enforcement action may come without further notice if violations are observed in the future.
— A request for the retailer to submit a written response to the FDA within 15 working days of receiving the warning letter.
It’s crucial that retailers alert store managers to the importance of these FDA correspondences, because their warning letters may go directly to the audited store vs. a chain’s headquarters. A busy store manager may let valuable time pass before notifying the proper supervisor.