For Immediate Release: March 13, 2019 Statement From:

FDA is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products), and prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products.

In addition, FDA expects manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under these new conditions to submit premarket applications to the agency by Aug. 8, 2021. This application date is one year earlier than the agency previously proposed.

When we first announced our comprehensive plan for tobacco and nicotine regulation in July 2017, we outlined a framework to better protect kids and to significantly reduce tobacco-related disease and death. We are continuing to implement that framework today. It remains the blueprint for the agency’s tobacco-related policymaking.

This framework first and foremost includes actions aimed at ultimately bringing us closer to our vision of a world where combustible cigarettes no longer create or sustain addiction – making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or transition to potentially less harmful products.

This plan puts nicotine at the center of our regulatory efforts. It seeks to regulate nicotine levels in combustible cigarettes to render them minimally or non-addictive. At the same time, we’re advancing new policies to encourage the development of products that can deliver nicotine to currently addicted adult smokers without all of the harmful effects of combustion, including novel forms of medicinal nicotine replacement therapy .

With the significant strides made in recent years to reduce conventional smoking among both youth and adults, we appeared poised to overcome one of the most pernicious public health challenges of our times – the death and disease caused by cigarette smoking. Our multi-year policy framework will continue to accelerate these declines in tobacco use.

However, it has become clear that a recent surge in e-cigarette use among youth, which had appeared to be leveling off at the time our comprehensive plan was first announced in July 2017, is threatening the progress we’ve made in reducing youth tobacco use. The most recent data show more than 3.6 million middle and high school students across the country were current (past 30 day) e-cigarette users in 2018. This is a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently and they were using flavored e-cigarette products more often than in 2017. This is particularly troubling given that research shows that kids using e-cigarettes are more likely to take up combustible cigarettes.

The epidemic-level rise in youth e-cigarette use has prompted a series of escalating actions by the FDA in both enforcement and public education. It has also required us to take a critical look at our policies and regulatory priorities.

Evidence shows that youth are especially attracted to flavored e-cigarette products, and that minors are able to access these products from both brick-and-mortar retailers, as well as online, despite federal restrictions on sales to anyone under 18. We also continue to be concerned about cigar use among youth – flavored cigars in particular – which our enforcement work shows are also being illegally sold to minors. With these concerns in mind, today, we’re advancing our policies aimed at preventing youth access to, and appeal of, flavored e-cigarettes and cigars.

There are many aspects of these policies outlined in a draft compliance policy published today, which we intend to review comments on and finalize as quickly as possible. We expect several things to happen because of these policy changes:

We expect that some flavored e-cigarette products will no longer be sold at all.

We expect that other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021.

We expect some flavored cigars will no longer be sold.

Specifically, today, with the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump, the FDA is proposing to end our current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored). Previously, for all ENDS products on the market as of Aug. 8, 2016, the FDA had announced our intention not to enforce the premarket review requirements until August 2022, with the expectation that many such products would remain on the market. In addition, under this previous policy, we intended to continue deferring enforcement while an ENDS product’s application was pending review.

Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization.

We’ll prioritize enforcement to prevent the access and appeal of these products to kids.

I’m taking this step to prevent youth access and address youth appeal of flavored ENDS. But because I believe that ENDS products still hold promise to help transition currently addicted adult smokers to potentially less harmful sources of nicotine, the FDA intends to prioritize its enforcement to focus on protecting youth from becoming addicted to nicotine.

We’re proposing to prioritize enforcement of flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products. For instance, we’ll consider whether the products are sold under circumstances, whether at retail or online, without heightened age verification.

Our proposed policy provides examples of circumstances that we’ll consider – for example, if flavored ENDS products are sold in locations where minors can enter at any time (e.g., the entire establishment or an area within the establishment); or, for online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records. We’re also specifically seeking comment on, among other things, whether there are new technologies that can help prevent youth access at retail locations and intend to consider the use of those tools when we finalize the guidance.

Today’s draft guidance states our expectation that manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under circumstances to limit youth access and appeal also submit their premarket applications by Aug. 8, 2021. This is an important change in our expectations and enforcement priorities. For all flavored ENDS products, including any that continue to be offered for sale under circumstances involving heightened age verification, the FDA expects manufacturers to prepare and submit applications that demonstrate these products meet the public health standard by Aug. 8, 2021.

In addition, we’re proposing to prioritize enforcement of unauthorized ENDS products that are targeted to minors or likely to promote use of ENDS by minors. Any efforts that entice minors to use tobacco products are of particular concern to the FDA. For example, the agency has already issued warning letters for products that resemble kid-friendly foods and drinks or that resemble other non-ENDS products that are often consumed by youth. Manufacturers and retailers are on notice that we’ll continue to be vigilant about efforts to make tobacco products that appeal to kids.

At this time, we aren’t proposing to end our current compliance policy as it applies to tobacco-, mint-, and menthol-flavored ENDS products, except for those products that are targeted to minors or likely to promote use of ENDS by minors. This approach reflects a careful balancing of public health considerations.

Recent evidence indicates that mint- and menthol-flavored ENDS products are preferred more by adults than minors. We’re also aware that some adults may be using mint- and menthol-flavored ENDS products with the goal of ceasing combusted tobacco use, seeking health benefits at the individual level, and may be at risk of migrating back to cigarettes. We won’t ignore data regarding the popularity of mint- and menthol-flavored ENDS among kids, should the concern rise. We’ll continue to use all available resources to monitor the rates and use patterns among youth and adults for these products, and we’ll reconsider our policies with respect to these products, if appropriate.

We’re also continuing our efforts aimed at enforcement and education.

This summer, we’ll unveil the first television advertisement aimed at educating children about the risks of e-cigarettes. I call on others who are committed to these same goals to also consider stepping up their efforts aimed at educating children of the risks of tobacco products generally, and e-cigarettes specifically. E-cigarette use among kids has become so widespread, so pervasive, and so troubling, that we risk addicting an entire generation of children on nicotine and watching the dramatic gains we’ve made in reducing smoking rates be erased. If current trends regarding youth use of ENDS products persist, the agency will change our approach. These increases in youth use must stop. We cannot allow a generation of children to become addicted to nicotine through e-cigarettes. If the 2019 National Youth Tobacco Survey continues to show sharp increases in youth use of tobacco products, the FDA will consider additional measures to address this crisis. We’ll take all appropriate actions necessary to stop these rates from increasing.

Additionally, we’re also taking steps to address youth use of flavored cigars. Recent data show that nearly 1.3 million middle and high school students across the country were current (past 30 day) cigar users in 2018. Youth continue to use these dangerous combusted tobacco products due, in part, to the availability and appeal of fruit and other flavors. And research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth use flavored cigars. These data also indicate that eliminating flavors from cigars would likely help prevent cigar initiation by young people. Flavors are added to cigars and other tobacco products for various reasons, such as reducing the harshness, bitterness and astringency of tobacco products during inhalation and to soothe irritation during use.

Under the revised compliance policy, 30 days after the guidance is finalized, any flavored cigars (other than tobacco-flavored) that were on the market on Aug. 8, 2016, and that meet the definition of a new tobacco product, would be subject to enforcement. As a result, flavored cigar products that are not grandfathered tobacco products and lack marketing authorization would no longer be subject to the August 2017 Compliance Policy. The FDA would prioritize enforcement of such products if they did not come off the market 30 days after the final guidance. They would have to seek premarket authorization to be re-introduced to the market. Additionally, we’re moving forward with a proposed rule to ban all characterizing flavors in cigars.

The FDA will continue to use our enforcement tools to ensure manufacturers comply with the law. We’ll continue to hold retailers accountable for illegally selling tobacco products to minors. Manufacturers have the means to control the distribution and sale of their products to retail customers by, for example, including or requiring terms, conditions, or controls in their contracts with downstream distributors (wholesalers, distributors, importers and/or retailers) to prevent youth access. Therefore, we’ll be looking to manufacturers of flavored ENDS and cigars to comply with the requirements of the Federal Food, Drug and Cosmetic Act and regulations and prevent the sale of their products to minors.

Ultimately, we expect these steps designed to address flavors and protect youth will dramatically limit the ability of kids to access tobacco products we know are both appealing and addicting. Our proposal reflects a very careful public health balance between closing the on-ramp for kids to become addicted to nicotine through tobacco products, while allowing for the promise of an off-ramp for adult smokers through access to potentially less harmful forms of nicotine delivery.

We intend to review comments and implement the policies 30 days after the guidance is finalized. However, we’re hopeful manufacturers and retailers will begin taking voluntary steps to further curb youth access to and appeal of these products. As we’ve said before, responsible manufacturers certainly don’t need to wait for the FDA to finalize policies to act. They can immediately stop certain marketing and sales practices – the ones we believe contribute to the problem of youth access and youth appeal. Likewise, manufacturers need not wait to submit premarket tobacco product applications for ENDS products, flavored or otherwise.

In 2017, when the agency extended certain compliance deadlines for newly deemed tobacco products, we recognized that, to promote higher quality applications, we could provide greater transparency about our recommendations and requirements through guidance and rulemaking. We had already published some resources to aid industry application submission. For instance, the FDA has published the Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) draft guidance ; we’ve published the Tobacco Product Master File Guidance and a Small Entity Compliance Guide for Deeming ; and we’ve conducted educational webinars describing, among other things, the statutory requirements for premarket applications. We continue to develop proposed rulemaking regarding the requirements for premarket submissions. Manufacturers, however, need not wait to engage the agency. Our door is open, and we welcome discussions with ENDS products manufacturers about their preparation of premarket submissions.

Our pledge to reduce youth use of e-cigarettes is deeply rooted and has broad support within the Trump Administration. Nobody wants to see children becoming addicted to nicotine. Our dedication to this effort will endure and our commitment to advancing our comprehensive framework will continue. Our policies have been announced and advanced through a careful and deliberate process that involved the formulation of a broad consensus among those whose efforts are needed in making sure that these rules and guidances come to fruition. We won’t tolerate a whole generation of kids becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same unreviewed products, and we’ll continue to put the full scope of our regulatory tools against this mounting public health crisis.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Inquiries Media: Michael Felberbaum 240-402-9548 Consumer: 888-INFO-FDA

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