FDA seeks to extinguish tobacco sales for 8 retailers

The FDA filed complaints initiating the first-ever No-Tobacco-Sale Order (NTSO) actions for a group of retailers who repeatedly violated 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. The FDA’s actions would prohibit the sale of regulated tobacco products at eight retail establishments located in New Jersey, Michigan, Illinois, Maryland, and Missouri for 30 days.

Law

Under the Family Smoking Prevention and Tobacco Control Act of 2009 (P.L. 111-31) the FDA has authority to regulate the manufacture, marketing and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.

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 becomes effective, a retailer is responsible for ensuring that the establishment does not sell regulated tobacco products during the specified period.

Compliance

Removing or covering tobacco products are examples of steps that a retailer may undertake to ensure compliance with an NTSO, but these specific actions are not required. The retailer has discretion on 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 will conduct unannounced compliance check inspections during that period to check whether the establishment is complying with the terms of the order.

The FDA provides compliance education and training opportunities to retailers and monitors compliance through surveillance, inspections and investigations. When violations are found, the agency generally issues warning letters and may take enforcement actions, including civil money penalties and NTSOs. As of Oct. 1, 2015, the FDA has conducted more than 508,000 inspections of tobacco product retail establishments, issued more than 35,700 warning letters to retailers for violating the law and initiated more than 5,200 civil money penalty cases.