FDA Issues First-Ever No Sale Orders

Agency issues a No-Tobacco-Sale Order to eight retailers for repeatedly selling tobacco products to minors.

October 30, 2015

WASHINGTON – This week the U.S. Food and Drug Administration filed complaints initiating the first-ever No-Tobacco-Sale Order (NTSO) actions for retailers that repeatedly violated certain restrictions on the sale and distribution of tobacco products, including sales to minors. Under the law, the FDA may pursue an NTSO against retailers that have a total of five or more repeated violations of those restrictions during compliance inspections within 36 months.

“These enforcement actions will send a powerful message to all retailers that there are real consequences for repeatedly violating the law,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

The FDA’s actions seek to prohibit the sale of regulated tobacco products at eight retail establishments for 30 days that are located in New Jersey, Michigan, Illinois, Maryland and Missouri. After the FDA initiates an NTSO action by filing a complaint, a retailer has the ability to respond to the complaint, but must generally do so within 30 days. 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.

Removing or covering tobacco products are examples of steps that a retailer may choose to take to ensure compliance with an NTSO, but these specific actions are not required. It is up to the retailer to decide what measures to take to ensure no regulated tobacco products are sold at the store during the period of time specified in the order. The FDA plans to conduct unannounced compliance check inspections during that period to check whether the establishment is complying with the terms of the order.

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