FDA takes enforcement action against retailers who have repeatedly sold tobacco products to minors

Agency pursues first-ever orders barring retailers from selling regulated tobacco products for specified period of time

This week the U.S. Food and Drug Administration 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. 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. “These enforcement actions will send a powerful message to all retailers that there are real consequences for repeatedly violating the law.”

While progress has been made in reducing the burden of tobacco use on the nation, each day in the U.S. more than 2,600 youth under age 18 smoke their first cigarette, and nearly 600 become daily cigarette smokers. Additionally, results of the National Youth Tobacco Survey show an estimated 4.6 million middle and high school students currently used a tobacco product in 2014. One of the ways the FDA combats youth tobacco use is through its compliance and enforcement efforts, including encouraging retailer compliance and taking action when violations occur.

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 and S Grocery Inc. in Newark, New Jersey;
C and C Supermarket LLC in Irvington, New Jersey;
Yemco Fuel Inc. and Nakeeb Hassan doing business as Marathon in Detroit, Michigan;
Kat Party Store Inc. doing business as Mr. Grocer Liquor Store in Detroit, Michigan;
Family Food Market Inc. in Detroit, Michigan;
Horizon Enterprises Inc. doing business as 95th Mobil and Food Mart in Chicago, Illinois;
Mon-Jan Corp. doing business as Monaghan’s Pub in Baltimore, Maryland; and
MFA Petroleum Company doing business as Break Time 3028 in Columbia, 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.

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.

The Family Smoking Prevention and Tobacco Control Act of 2009 amended the Federal Food, Drug & Cosmetic Act (FD&C Act) to give the FDA important new authority to regulate the manufacture, marketing and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.

Consumers and other interested parties can report a potential tobacco-related violation of the FD&C Act, including sale of tobacco products to minors, by using the FDA’s Potential Tobacco Product Violation Reporting Form.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.