A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

More than a year ago, the FDA unveiled a broad policy to reduce the death and disease caused by smoking. Smoking remains the number one preventable cause of death in America, killing nearly half a million people a year. If we aren’t successful in more sharply reducing the rate of addiction to tobacco, then we’ll continue to see this needless death and disease. FDA’s new legal authorities to regulate tobacco ‒ as part of the Tobacco Control Act ‒ empowered us to alter this trajectory.

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That’s because we didn’t foresee the extent of what’s now become one of our biggest challenges. We didn’t predict what I now believe is an epidemic of e-cigarette use among teenagers. Today we can see that this epidemic of addiction was emerging when we first announced our plan last summer. Hindsight, and the data now available to us, reveal these trends. And the impact is clearly apparent to the FDA.

Unfortunately, I now have good reason to believe that it’s reached nothing short of an epidemic proportion of growth.

I use the word epidemic with great care. E-cigs have become an almost ubiquitous ‒ and dangerous ‒ trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable. I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.

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But we must do more to stem what I see as an epidemic of use of e-cigs among teens, and deeply disturbing trends that show no sign of abating. So, we’re also going to re-visit the compliance policy that we announced last summer to extend the application compliance periods for certain deemed products, including and especially the e-cigarettes that were on the market as of Aug. 8, 2016. Under the current policy, the compliance date for filing applications for such products was extended to Aug. 8, 2022.We exercised that discretion for ENDS products because, as part of the tobacco and nicotine regulatory framework that we developed, which includes pathways to transition smokers off combustible cigarettes, we wanted to allow time for FDA to establish and more clearly explain the series of appropriate regulatory gates ‒ and for companies to prepare quality applications for new products like e-cigarettes. That’s where the e-cigarettes and other non-combustible products come into play. We wanted to make sure ‒ before we began enforcement of the application requirements ‒ that there was a clear, viable pathway to seek FDA authorization to market alternative products for adult smokers who still sought access to nicotine.

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But our public health mandate to prevent youth addiction has forced us to now revisit this element of our overall plan.

The legal standard for FDA premarket review of a new tobacco product includes consideration of whether the product would be appropriate for the protection of the public health. We must factor in whether these products get kids addicted to nicotine. It’s that simple. And we are taking aggressive actions today to address this.

This may create some obstacles for some adults who also enjoy e-cigs. These are the hard tradeoffs that we’re grappling with. But the youth risk is paramount.

It’s now clear to me, that in closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.

This isn’t our choice alone.

I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends. In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products. And the risks mounted.

Well, I’m here to tell them that this prior approach is over. The FDA is closely watching the trends in youth use. And if, as we expect, preliminary data that’s in our possession and will be finalized and released in the coming months confirm our present observations that the youth use of e-cigs is rising very sharply; we’ll swiftly change course.

In the meantime, the FDA is announcing an escalating series of actions to forcefully address youth use trends.

It starts with the steps that we’re taking today, with the announcement of the largest coordinated tobacco compliance effort in FDA’s history.

In addition, as I noted, we’re seriously reconsidering our compliance dates for the submission of product applications when it is apparent that there’s widespread youth use of the product. We’re especially focused on the flavored e-cigarettes. And we’re seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.

Today, we sent letters to five e-cigarette manufacturers whose products were sold to kids during the enforcement blitz and that, collectively, represent more than 97 percent of the current market for e-cigs — JUUL, Vuse, MarkTen, blu e-cigs, and Logic. These brands will be the initial focus of our attention when it comes to protecting kids.

They’re now on notice by the FDA of how their products are being used by youth at disturbing rates.

Given the magnitude of the problem, we’re requesting that the manufacturers of these brands and products come back to the FDA in 60 days with robust plans on how they’ll convincingly address the widespread use of their products by minors, or we’ll revisit the FDA’s exercise of enforcement discretion for products currently on the market.

Let me be clear. This may require these brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements.

In the meantime, we’ll be investigating their marketing and sales practices, including with boots on the ground inspections. The FDA is going to continue to work to find out why so many kids are using and abusing these products.

And we’re not going to stop there.

We’re also re-examining the enforcement discretion we currently exercise for other e-cig products currently on the market without authorization. Today’s letters target the five dominant e-cig manufacturers, including those whose products were purchased by kids in our enforcement blitz. But the policy reconsiderations apply to the entire category.

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