FDA has initiated enforcement action against several retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.
The agency filed complaints seeking No-Tobacco-Sale Orders, which seek to bar the two retail locations from selling tobacco products for 30 days. The two retail outlets that are the subject of these NTSO actions are a Walgreens store in Miami and a Circle K store in Charleston, South Carolina.
Notably, Walgreens is currently the top violator among pharmacies that sell tobacco products, with 22 percent of the stores inspected having illegally sold tobacco products to minors.
FDA Commissioner Scott Gottlieb said he will request a meeting with corporate management of Walgreens to “discuss whether there is a corporate-wide issue related to their stores’ non-compliance.”
“[I will] put them on notice that the FDA is considering additional enforcement avenues to address their record of violative tobacco sales to youth,” FDA Commissioner Scott Gottlieb, said in a statement. “I’m also deeply disturbed that a single pharmacy chain racked up almost 1,800 violations for selling tobacco products to minors across the country.”
An estimated 4.9 million middle and high school students reported current (past 30 days) use of any tobacco product in 2018, according to preliminary results of the 2018 National Youth Tobacco Survey.
An “epidemic-level rise” in e-cigarette use over the last year has led overall tobacco product use to increase by 38 percent among high school students (to 27.1 percent) and by 29 percent among middle school students (to 7.2 percent) in the last year, reversing the declines seen in the last few years, the survey said.
The NTSO action against this Walgreens outlet follows the issuance of more than 1,550 warning letters and 240 civil money penalty actions against Walgreens stores nationwide for unlawful tobacco product sales to minors. This is, however, the first NTSO action taken against a Walgreens store.
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 for sales to minors.
Retailers who receive an NTSO complaint from the FDA 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, a retailer is responsible for ensuring that the establishment does not sell tobacco products during the specified period.
FDA said it plans to conduct unannounced compliance check inspections during that period to check whether each establishment is complying with the terms of the order and will take further action if necessary.
