FDA Takes New Steps to Address Youth E-Cigarette Use

The U.S. Food and Drug Administration (FDA) has announced a series of critical and historic enforcement actions related to the sale and marketing of e-cigarettes to children. In the largest coordinated enforcement effort in the its history, the agency issued more than 1,300 warning letters and 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, MD, signaled that the agency intends to take new and significant steps to address this challenge in a speech at the agency’s headquarters.

“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. 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,” said Dr. Gottlieb. “…We 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. Our comprehensive plan on nicotine and tobacco regulation remains intact and we remain committed to its goals to reduce tobacco-related disease and death, including our efforts to reduce the nicotine in combustible products to render cigarettes minimally or nonaddictive. We’re also fully committed to the concept that products that deliver nicotine exist on a continuum of risk, with combustible products representing the highest risk and electronic nicotine delivery systems perhaps presenting an alternative for adult smokers who still seek access to satisfying levels of nicotine but without all of the harmful effects that come from combustion. But in enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products.”

Enforcement Strategy

As part of the agency’s Youth Tobacco Prevention Plan and ongoing work to protect youth from the dangers of tobacco products, the FDA has taken a series of actions over the past several months to more immediately target the illegal sales of e-cigarettes to youth, as well as the child-friendly marketing and appeal of these products.

The FDA is stepping up those efforts indefinitely. One aspect of the agency’s plan will entail increased enforcement. The more than 1,300 warning letters and fines to retailers announced were part of a large-scale crack-down on the sale of e-cigarettes to minors at both brick-and-mortar and online retailers. 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 comprise over 97% of the U.S. market for e-cigarettes.

In addition, the FDA also issued 12 warning letters to other online retailers who are selling misleadingly labeled and/or advertised e-liquids resembling child-friendly food products such as candy and cookies. These products were the subject of agency action in May and, subsequently, are no longer being sold with the offending labeling and advertising by the companies that received the May warning letters. However, the retailers receiving the warning letters today are still advertising and selling the violative products. Several of these retailers were also cited for illegally selling the products to minors.

In addition to these new actions, the FDA had previously issued more than 60 warning letters and fines to businesses that sold JUUL-brand products to minors stemming from another enforcement blitz this past spring. The agency also recently sent letters to JUUL Labs and several other companies requiring them to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of their products. The FDA is currently investigating whether manufacturers introduced certain e-cigarette products to the market after August 8, 2016, and may be subject to enforcement for marketing those products without premarket authorization.

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.

Youth Use of E-Cigarettes

Over the past several years, e-cigarettes were the most commonly used tobacco product by youth. In fact, more than 2 million middle and high school students were current users of e-cigarettes in 2017.

The FDA now believes that youth use of e-cigarettes is reaching epidemic proportions. This belief is based on not just the results of the agency’s enforcement actions, but also recent sales trends; news coverage; increased concerns among children, parents, and educators; as well as preliminary data that will be finalized and released in the coming months.

To address these trends, and as another part of the agency’s effort, the FDA is reexamining its compliance policy dates for the submission of premarket tobacco applications to the FDA for certain e-cigarettes. Toward these goals, and recognizing the critical role manufacturers must play in curtailing youth use of their products, the FDA issued letters to the manufacturers of the five top-selling national brands. All of these brands—JUUL, Vuse, MarkTen XL, blu e-cigs, and Logic—made up a vast majority of the products illegally sold to minors as part of the blitz this summer. The agency is asking each company to submit to the FDA within 60 days plans describing 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. This could mean requiring these brands to remove some or all of their flavored products that may be contributing to the rise in youth use from the market until they receive premarket authorization and otherwise meet all of their obligations under the law.

As part of the FDA’s comprehensive plan, the agency also continues to explore clear and meaningful measures to make tobacco products less toxic, appealing, and addictive, with an intense focus on youth. This could include measures on flavors/designs that appeal to youth, child-resistant packaging, and product labeling to prevent accidental child exposure to liquid nicotine. The FDA also issued an advance notice of proposed rulemaking in March to seek public comment on the role that flavors in tobacco products play in attracting youth. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS to further reduce youth exposure and access to these products.

The FDA has also expanded “The Real Cost” public education campaign with messages focused on preventing youth use of e-cigarettes. The FDA will also launch a new, full-scale e-cigarette campaign targeted to youth.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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