FDA Acts on Repeated Tobacco Sale Violations

Agency could stop a Walgreens and a Circle K from selling products for 30 days.
February 11, 2019

WASHINGTON, D.C. – The U.S. Food and Drug Administration has initiated enforcement against specific Walgreens and Circle K stores for repeated violations of tobacco sale and distribution restrictions, according to an FDA announcement.

The agency is seeking No-Tobacco-Sale Orders (NTSO), which could bar two specific outlets from selling tobacco products for 30 days. One is a Walgreens store in Miami, Florida, and the second is a Circle K in Charleston, South Carolina.

The FDA reports that among pharmacies selling tobacco, Walgreens is currently the top violator, with 22% of the stores inspected having illegally sold tobacco products to underage consumers.

“I will be writing the corporate management of Walgreens and requesting a meeting with them to discuss whether there is a corporate-wide issue related to their stores’ non-compliance and put them on notice that the FDA is considering additional enforcement avenues to address their record of violative tobacco sales to youth,” said FDA Commissioner Scott Gottlieb, M.D.  

“We all share the important responsibility of keeping harmful and addictive tobacco products out of the hands of kids. Retailers in particular—especially those who position themselves as health-and-wellness-minded businesses—are on the frontlines of these efforts and must take that legal obligation seriously,” he said. “The FDA will continue to hold retailers accountable by vigorously enforcing the law.”

Gottlieb added that the FDA is currently evaluating data on other large, national retail chains to identify those that have high instances of repeat violations.

When violations are found, the agency generally issues warning letters and may take enforcement actions, including civil money penalties and NTSOs. Since its retailer enforcement program began in 2010, the FDA has issued more than 81,570 warning letters to retailers for violating the law, initiated more than 19,800 civil money penalty cases and issued 145 NTSOs, as of Dec. 31, 2018.

The FDA’s NTSO action against the Miami Walgreens outlet follows the issuance of more than 1,550 warning letters and 240 civil money penalty actions against the U.S. chain for unlawful tobacco sales to minors. This is, however, the first NTSO action taken against a Walgreens store. To compare Walgreens’ rate of violations to other national, corporate-owned chains, 17.5% of Walmart stores, 14% of Dollar General stores and 9.6% of Rite Aid stores inspected had violations for illegal sales of tobacco products to minors.

While the NTSO action against Circle K is not its first, it marks the first time the agency has initiated an NTSO complaint for the sale of deemed products (cigars) to minors. Since 2010, the FDA has issued over 1,045 warning letters and 205 civil money penalty actions to retailers doing business as Circle K based on tobacco sales to minors.

Under the law, the FDA may pursue an NTSO against a retail outlet that has committed a total of five or more repeated violations of federal tobacco regulations within 36 months. After the NTSO is initiated, the retailer has 30 days to respond to the complaint. Retailers who receive an NTSO complaint may enter into a settlement agreement or respond with an answer and contest the allegations before an administrative law judge.

If an NTSO goes into effect, the retailer is responsible for ensuring that the establishment does not sell tobacco products during the specified period. This may involve removing or covering up tobacco products to comply, but these specific actions are not required.

The FDA plans to conduct unannounced compliance checks during the NTSO’s 30-day period to ensure that both stores follow the terms of the order. Consumers and other interested parties can report a potential tobacco-related violation of the Food Drug & Cosmetic Act, including sale of tobacco products to minors, by using the FDA’s Potential Tobacco Product Violation Reporting Form.