The FDA may pursue a No-Tobacco-Sale Order (NTSO) against retailers that have a total of five or more repeated violations of certain restrictions within 36 months. During the period of the NTSO, retailers are prohibited from selling regulated tobacco products at the specified location.
If an NTSO goes into effect, a retailer is responsible for ensuring that the establishment does not sell regulated tobacco products during the specified period. They may decide to remove or cover the products, but it is not required.
The retailer can either enter into a settlement agreement with the agency that results in a final order issued by the Administrative Law Judge (ALJ), or it may choose to go to a full hearing before an ALJ.
The FDA will also conduct unannounced compliance checks during the time of an NTSO to ensure the retailer is complying with the order. Those results are not available in the FDA’s inspection database.