The U.S. Food and Drug Administration (FDA) has stepped up a series of enforcement actions related to the sale and marketing of e-cigarettes to youth.
On Sept. 12, the agency announced it had issued more than 1,300 warning letters and civil money penalty complaints (fines) to retailers who illegally sold Juul and other e-cigarette products to minors during a nationwide undercover blitz of brick-and-mortar and online stores this summer.
As a result of these violations of the law—and other indications that e-cigarette use among youth has hit epidemic proportions—FDA Commissioner Scott Gottlieb, M.D., signaled the agency intends to take new and significant steps to address this challenge.
“We’re committed to the comprehensive approach to address addiction to nicotine that we announced last year. But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger. This starts with the actions we’re taking today to crack down on retail sales of e-cigarettes to minors.”
Gottlieb added, “We will also revisit our compliance policy that extended the dates for manufacturers of certain flavored e-cigarettes to submit applications for premarket authorization. I believe certain flavors are one of the principal drivers of the youth appeal of these products. While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids. We cannot allow a whole new generation to become addicted to nicotine. In the coming weeks, we’ll take additional action under our Youth Tobacco Prevention Plan to immediately address the youth access to, and the appeal of, these products.”
The commissioner asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications.
One aspect of the agency’s plan will entail increased enforcement. The FDA sent more than 1,300 warning letters and fines to retailers as part of a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors at both brick-and-mortar and online retailers. The undercover drive was conducted June through August.
The vast majority of the violations were for the illegal sale of five e-cigarette products—Vuse, Blu, Juul, MarkTen XL and Logic. These five brands currently account for more than 97 percent of the U.S. market for e-cigarettes. On Sept. 12, the FDA issued letters to these manufacturers. Each is to submit to FDA within 60 days their plans of how they will address the widespread youth access and use of their products. If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency.
Also on Sept. 12, the FDA issued 12 warning letters to other online retailers that are selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies. These products were the subject of FDA action in May and, subsequently, are no longer for sale with the offending labeling and advertising by the companies that received the May warning letters. However, the FDA said the retailers are receiving the warning letters because they are still advertising and selling the “violative products.” Several of these retailers were also cited for illegally selling the products to minors.
The FDA also continues to conduct checks of retail establishments that sell tobacco products to ensure compliance with federal laws. In total as of Sept. 1, the FDA has conducted 978,290 retail inspections; issued 77,180 warning letters to retailers for violating the law; and initiated approximately 18,560 civil money penalty cases.
The agency also has issued more than 135 No-Tobacco-Sale Order complaints, which can result in retailers being prohibited from selling tobacco products for specified periods of time.
Keep reading:
17 Companies Cease Sale Of E-Liquids In ‘Kid-Friendly’ Packaging
Nine States’ Attorneys General Ask FDA To Ban Flavored Tobacco
