U.S. health officials plan to ask for a meeting with top management from Walgreens Boots Alliance to discuss what they said was a pattern of illegal tobacco sales to minors at the Deerfield-based pharmacy giant's stores.
The Food and Drug Administration said Thursday that it would block a Walgreens store in Miami from selling tobacco products for 30 days. The agency also said 22 percent of the Walgreens stores it had inspected had illegally sold tobacco products to minors.
The FDA inspected 6,350 Walgreens stores, said Michael Felberbaum, an agency spokesman. Walgreens has received more than 1,550 warning letters from the FDA and has incurred 240 financial penalties since 2010 for selling tobacco to minors, he said.
"Walgreens is currently the top violator among pharmacies that sell tobacco products," the agency said in a statement.
FDA Commissioner Scott Gottlieb said the agency is considering additional enforcement action against Walgreens to "address their record of violative tobacco sales to youth." The company has said recently that it is pulling back on retail sales amid broader changes in its strategy.
Walgreens said it takes the matter "very seriously" and has taken steps to address the problem, including requiring store clerks to ask anyone purchasing tobacco for identification, regardless of age, and imposing tougher disciplinary actions against employees who don't follow its policies.
"We recognize the seriousness of this issue and welcome the opportunity to meet with the FDA administrator to discuss all of the steps we are taking," Walgreens spokesman Jim Cohn said in an email.
Gottlieb said he was particularly concerned about how selling cigarettes in a pharmacy setting influenced consumer perceptions of the health effects of smoking. CVS Health, the giant drugstore chain that recently merged with health insurer Aetna, stopped selling tobacco products in 2014.
"The FDA will continue to hold retailers accountable by vigorously enforcing the law," Gottlieb said.
In December, Walgreens posted mediocre quarterly results and said it would cut costs. While prescriptions increased in its pharmacies, same-store retail sales, which include items such as shampoo and beauty products as well as tobacco, fell 3.2 percent in the U.S. Walgreens blamed the decline in part on de-emphasizing tobacco.
The FDA's tobacco policies have been in the spotlight in recent months amid what health regulators have described as an epidemic increase in teen vaping. In 2017, more than 2 million middle- and high-school students used e-cigarettes, according to the Centers for Disease Control and Prevention. About 4.9 million middle- and high-school students said they'd used a tobacco product in the 30 days prior, according to preliminary results of the 2018 National Youth Tobacco Survey.
Vaping is viewed as a potential way to help smokers kick the habit, but it has also been seen as a gateway to cigarette use for younger people. The FDA has been trying to balance the potential benefits of such devices against the possibility that they could lead to higher rates of nicotine addiction.
There is growing concern that the increase in vaping could lead to more cigarette smoking by young users, along with a rise in the corresponding health risks, after years of headway in discouraging tobacco use. Declining smoking rates in the U.S. in recent decades have been considered a major public-health victory. Gottlieb has said he won't tolerate any rise in youth smoking.
Meanwhile, major tobacco companies have been betting on e-cigarettes as a way to offset a decline in sales of cigarettes and other tobacco products. Marlboro maker Altria Group spent $13 billion last year to take a 35 percent stake in Juul Labs, which makes vaping devices that are popular with young users.
Children and teens who had used e-cigarettes were four times more likely to have taken up cigarette smoking than those who didn't vape, according to a recent study in the Journal of the American Medical Association. And a separate study by the Harvard T.H. Chan School of Public Health found common e-cigarette flavors may harm users' lungs.
A JAMA Pediatrics study published in November found that Walgreens was more likely than other chains to sell tobacco products to minors, even after adjusting for local demographics and state tobacco sales rules. From 2012 to 2017, Walgreens pharmacies had a much higher rate of violations of federal rules governing tobacco sales to minors than other chains, the study found.
Gottlieb proposed measures in November for restricting sales of most flavored e-cigarettes and limiting them to specialized shops and online retailers that can verify a purchaser's age. He has also taken aim at flavored tobacco, calling menthol flavors in nicotine products a major problem that has made it easy for young people to start smoking. The FDA has been said to be considering restrictions on menthol.
According to FDA rules, stores must check the photo identification of everyone under age 27 who attempts to purchase any tobacco product. Federal rules prohibit the sales of tobacco to people under 18 years old. Some states have minimum ages that are higher.
The Family Smoking Prevention and Tobacco Control Act, signed into law in 2009, bans sales to minors and gives the FDA authority to regulate the distribution and marketing of tobacco products, according to the agency's website.
The agency also plans to block tobacco sales at a Circle K convenience store in Charleston, South Carolina.