E-cigarettes are inherently harmful to youth, posing risks to the developing brain. The President recognized a need to act on e-cigarettes, and he recognized the need to do it in a careful way that is focused on protecting our kids, keeping options available for adults to transition away from combustible cigarettes, and ensuring swift review of applications for products to return to the market in a form that protects public health and keeps them away from kids.
As Prepared for Delivery
Good morning, everyone, and thank you for joining us.
We're here today for a simple reason: President Trump and America's public health officials will not stand idly by as a new generation of Americans becomes addicted to tobacco products and nicotine.
In 2019, youth use of e-cigarettes rose dramatically again, continuing a trend of increases in the prior years.
That is why, today, the Trump Administration announced a new enforcement policy to prioritize enforcement actions against the types of e-cigarettes that appeal most to kids. That means all flavored, cartridge-based e-cigarettes, except for tobacco and menthol. Youth overwhelmingly prefer cartridge-based e-cigarette products and the two flavors that we are not prioritizing – tobacco and menthol – are much less likely to be used by kids.
We will also prioritize enforcement against all e-cigarette products, regardless of the type or flavor, if the manufacturer does not put adequate measures in place to prevent youth access or if the products are targeted to minors.
President Trump understands this is a highly complex issue, which demands a balanced approach. That was the thinking behind the event the President held at the White House in December, which was an opportunity for public health advocates and industry to explain their perspectives and lay out the costs and benefits of various approaches. Under the President's leadership, we've developed a smart, targeted policy that protects our kids without creating unnecessary disruption.
E-cigarettes are inherently harmful to youth, posing risks to the developing brain. The President recognized a need to act on e-cigarettes, and he recognized the need to do it in a careful way that is focused on protecting our kids, keeping options available for adults to transition away from combustible cigarettes, and ensuring swift review of applications for products to return to the market in a form that protects public health and keeps them away from kids.
As we're prioritizing flavors and types of products that appeal most to kids, we are enforcing the law Congress passed in 2009, which required the FDA to pre-authorize the marketing of new tobacco products. Pursuant to regulations issued in 2016, that includes e-cigarettes and other electronic nicotine delivery systems.
Since then, e-cigarette manufacturers have had ample opportunity to apply for this authorization. Not a single product has received a marketing authorization.
In other words, all e-cigarettes currently on the market are illegal. E-cigarettes have remained on the market only because we have been exercising enforcement discretion.
We aimed to see whether e-cigarettes could serve as an effective off-ramp for adult smokers addicted to combustible cigarettes. We believe that remains a possibility.
But e-cigarettes as an off-ramp from addiction must not come at the expense of e-cigarettes being an on-ramp to nicotine for a new generation of children—which is what is occurring today.
The data on youth use compel us to take action and change our enforcement priorities. We're announcing a highly targeted approach, based on a careful examination of the latest data we have.
We are temporarily taking certain illegal products off the market if they are the types of products and flavors most widely used by kids.
By prioritizing enforcement against the products that are most widely used by kids, we're striking a balance, one that we've heard from many quarters is so important: offering e-cigarettes as an off-ramp for adults using combustible tobacco while ensuring these products aren't an on-ramp for our youth.
Manufacturers can still apply for marketing authorization for any tobacco product, including those coming off the market after today's announcement. Our door is open for manufacturers to apply for premarket authorization of these products, as Congress provided. FDA has made available a wide range of resources for companies to do this, and stands especially willing to facilitate small businesses working through this process.
Under court order, by May 12, 2020, manufacturers of any e-cigarette that remains on the market will have to apply for authorization, too. That court order is in addition to and independent of the enforcement policy that we have announced today.
Beginning in early February, 30 days from the publication of the notice of availability of this guidance in the Federal Register, we will be enforcing the law by prioritizing the products that most appeal to kids. We will continue to monitor use of e-cigarette products by youth, and take additional action as necessary.
What we've announced today is part of a comprehensive and aggressive approach to protecting the public health. That is why President Trump endorsed and signed legislation in December to raise the legal age for purchasing tobacco products to 21; together, these actions are part of a smart, balanced approach to protecting our kids.
Protecting American youth from the dangers of addiction is one of the most important public health duties we have, and we will continue this work as the current epidemic of youth addiction evolves.
The Trump Administration will not allow a new generation to fall prey to nicotine addiction.
That has been a longstanding commitment from the FDA throughout the Trump Administration, and that is continuing under our new FDA Commissioner, Dr. Stephen Hahn.
So, I now want to hand things over to Commissioner Hahn.
Commissioner Hahn?
