FDA singles out Walgreens in nicotine sales crackdown

The Food and Drug Administration is escalating its “forceful” crackdown on retailers and manufactures that allegedly sell nicotine-based products to minors. The initiative is part of the FDA’s Youth Tobacco Prevention Plan

“In recent months our vigorous enforcement efforts as part of the agency’s Youth Tobacco Prevention Plan have included a number of actions to combat the illegal sales of e-cigarettes to youth at brick-and-mortar and internet storefronts, as well as steps to target companies engaged in kid-friendly marketing that can increase the appeal of these products to youth,” FDA Commissioner Scott Gottlieb said in a statement.

On Monday, he announced his agency was “taking several new actions, focused on both retailers and manufacturers, as part of our commitment to combat youth access to e-cigarettes.” Those efforts included a letter sent on March 4 to the corporate management of Walgreen Co. (Walgreens Boots Alliance) to request a meeting to discuss “whether there is a corporate-wide issue related to their stores’ track record of violating the law by illegally selling tobacco products to kids.”

In total, the company’s stores have racked up almost 1,800 violations across the country, Gottlieb alleges.

“They’re currently the top violator among pharmacies that sell tobacco products, with 22 percent of the more than 6,350 stores that we inspected having illegally sold tobacco products to minors,” Gottlieb said. “Both the rate of violations and sheer volume of violative inspections of Walgreens stores are disturbing, particularly since the company positions itself as a health-and-wellness-minded business. This cannot possibly come as a surprise to corporate leadership, which is why I want to sit down with them to discuss the important role they play, as a nationwide retailer, in curbing this epidemic.”

“But we know that Walgreens isn’t alone,” he added. “In total, we’ve identified 15 national retail chains, either corporate-owned or franchised, whose rates of violative inspections exceed 15 percent of their total inspected stores since the inception of the FDA’s retailer compliance check inspection program in 2010.”

Companies with violation rates between 35-44 percent of all inspected stores, according to the FDA, are: Marathon, Exxon, Sunoco, BP, Citgo, and Mobil. Violation rates between 25-34 percent of all inspected stores: Shell, Chevron, Casey's General Stores, and 7-Eleven. Violation Rates between 15-24 percent of all inspected stores: Family Dollar, Kroger, Walgreens, Circle K, and Wal-Mart.

“We plan to similarly hold [the other companies] accountable. We will ask them to share with us what policies they have in place and what more they can commit to do to prevent youth tobacco sales. Companies should be on notice that the FDA is considering additional enforcement avenues to address high rates of violations,” Gottlieb said. “Ignoring the law and then paying associated fines and penalties should not simply be viewed as a cost of doing business.”

Walgreens issued a response to address the FDA’s allegations and enhanced scrutiny.

“We take this matter very seriously and have taken a number of steps to help address the important issue of sales of these products to minors, including requiring identification for anyone purchasing tobacco products regardless of age in all of our stores nationwide. In addition, we are training all of our store team members on the new requirements and strengthening disciplinary actions against store employees who violate the policy,” it wrote. “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 since the health and well-being of our customers is our top priority and core mission.”

The FDA also sent letters to more than 40 companies seeking information about whether more than 50 products, including a variety of flavored e-cigarette products, are being “illegally marketed and outside the agency’s current compliance policy.”

“Some of these companies may be attempting to capitalize on the troubling popularity of products like JUUL among kids by illegally selling similar products and outside of the compliance policy,” Gottlieb said. “We also need to determine if any of these products may be counterfeit knockoffs. If tobacco products are being unlawfully marketed and sold outside the FDA’s compliance policy, we’ll take action.”

Warning letters have similarly been sent to several companies for, among other things, selling electronic nicotine delivery system products and a waterpipe tobacco product with labeling and/or advertising that failed to include the required nicotine warning statement. They were asked to submit a written response within 15 working days describing corrective actions, including dates on which the company discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products. Continued failure to comply with the law could result in enforcement action, the FDA warned.