FDA Issues First No-Tobacco-Sale Orders
WASHINGTON — This week, the U.S. Food & Drug Administration (FDA) filed complaints initiating the first-ever No-Tobacco-Sale Order (NTSO) actions for a group of retailers who have repeatedly violated certain restrictions on the sale and distribution of tobacco products, including sales to minors.
The FDA’s actions seek to prohibit the sale of regulated tobacco products at eight retail establishments for 30 days. The eight retailers are:
- Thais Mini Market LLC, doing business as I & S Grocery Inc., Newark, N.J.
- C & C Supermarket LLC, Irvington, N.J.
- Yemco Fuel Inc. and Nakeeb Hassan, doing business as Marathon, Detroit.
- Kat Party Store Inc. doing business as Mr. Grocer Liquor Store, Detroit.
- Family Food Market Inc., Detroit.
- Horizon Enterprises Inc., doing business as 95th Mobil & Food Mart, Chicago;
- Mon-Jan Corp., doing business as Monaghan’s Pub, Baltimore.
- MFA Petroleum Co., doing business as Break Time 3028, Columbia, Mo.
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.
“Retailers are the first line of defense in preventing the illegal sale of harmful and addictive products like cigarettes and smokeless tobacco to youth,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products (CTP). “These enforcement actions will send a powerful message to all retailers that there are real consequences for repeatedly violating the law.”
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 may conduct unannounced compliance check inspections during that period to check whether the establishment is complying with the terms of the order.
When it finds violations, 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.
