Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency's ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use

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Oct 31, 2018, 09:18 ET

SILVER SPRING, Md., Oct. 31, 2018 /PRNewswire/ -- Last month, I issued a call to action – to the FDA and to the e-cigarette industry – to stem the alarming increase in youth use of e-cigarettes. For the FDA, that has included an escalating series of steps that utilize the full range of our regulatory authorities, including increased enforcement of age- and identification-verification requirements, as well as re-examining aspects of our comprehensive plan on tobacco and nicotine regulation in order to strengthen our Youth Tobacco Prevention Plan. We're committed to announcing a new action plan by mid-November that will set forth a series of new, forceful steps to firmly confront and reverse the youth addiction trends that are at epidemic levels.

For the e-cigarette industry, my message was simple: Step up. Even as the FDA builds a framework to mandate additional restrictions and actions to address these trends, we welcome voluntary steps by companies to address these concerns. I asked five manufacturers whose products, collectively, represent more than 97 percent of the current market for closed-system e-cigarettes to meet with me personally to discuss this vital public health challenge, as well as to submit written plans outlining the steps they intend to take to confront the rising trends in youth use. Each of these companies market products that recently had been sold illegally to minors, either through brick-and-mortar stores or online retailers. Everyone involved in this market has a shared responsibility to address this public health crisis.

Following that call to action, I have met in the past several weeks with the leadership of five companies – Altria Group Inc., JUUL Labs Inc., Reynolds American Inc., Fontem Ventures, and Japan Tobacco International USA Inc. These have been constructive meetings. The companies acknowledged the serious public health consequences associated with youth use of tobacco products. They presented thoughtful proposals, consisting not only of what steps they would take themselves to restrict youth access to and appeal of these products, but also steps that they think the FDA and other policy-makers can take to reverse the trends in youth use of e-cigarettes. Some stated explicitly that preventing youth use must be a priority, and that any potential benefits of e-cigarettes for adult smokers cannot justify significant increases in youth use and addiction.

The companies acknowledged the role that flavored e-cigarette products play in appealing to kids, as well as the role that flavored e-cigarettes can also play in helping adult smokers quit. On this point, their proposals at the meetings reflected a range of ideas: for instance, that the FDA restrict distribution of certain flavored products to channels with enhanced age verification processes. Or that the agency require certain products that are more appealing to kids to come off the market until these products receive premarket authorization from the agency.

The companies also acknowledged the power of social sourcing of tobacco products – in other words, of-age purchasers sharing or selling products to underage friends – in contributing to youth tobacco use. To address this issue, some companies said that they would support raising the minimum age to purchase tobacco to 21 years of age. Companies also described their current actions to promote retailer compliance with age- and identification-verification requirements, and they committed to providing more information in their written submissions to the agency.

These have been useful dialogues. We welcome the feedback and proposals to address the youth epidemic, which will help inform the FDA's consideration of policy approaches.

At the FDA, we're considering the data and proposals shared by the companies, in addition to the disturbing data in youth use trends that has come to light over the past months as we continue to re-examine the FDA's regulatory approach. We are committed to taking the necessary steps to fully confront the epidemic of e-cigarette use that has gripped the nation's youth and set in motion an accelerating epidemic. I've stated clearly, all options are on the table. In the coming weeks, we'll continue to communicate about the steps that we are taking to forcefully address youth use of e-cigarettes. And we will continue to seek public input from a diverse set of stakeholders, including public health advocates and the manufacturers and retailers affected by these policies.

To inform our approach, we're looking at a variety of factors, including how different types of electronic nicotine delivery systems (ENDS) products are used by kids; the popularity of various products, such as cartridge-based e-cigarettes; the popularity of non-tobacco flavors; and the strength of various distribution methods in ensuring robust age verification.

As we consider new and updated policies to our initial comprehensive plan for tobacco and nicotine regulation and address the rising rates of youth e-cigarette use, we'll also stay true to the public health goals that animated the approach that we announced in July 2017. We still believe that new innovations that don't use combustion, such as many e-cigarettes, may offer an important opportunity for adults to transition off combustible tobacco. We still believe that non-combustible forms of nicotine delivery may be less harmful alternatives for currently addicted adult smokers who still seek nicotine, without the risks associated with combustible cigarettes. And we want to keep this option for adults open.

But, as I've said before, the current trends in youth use are not tolerable. We have warned for more than a year that the availability of e-cigarettes cannot come at the expense of addicting a generation of youth on nicotine through these products. We gave ample warnings of the worrisome trends we were observing with respect to rising youth popularity of these products. Now we have hard data to support that public health tragedy that is now underway. And in order to firmly confront and reverse these trends – and fulfill the central premise of our public health mandate – we may need to take actions that might narrow the off-ramp from smoking for adults in order to close the on-ramp to nicotine addiction to kids.

Achieving the right balance requires a strong regulatory process that protects our nation's youth.

We welcome the constructive dialogue we had with manufacturers. These manufacturers have an opportunity to demonstrate – through their actions – that we can work collectively to address this crisis, and that they share our earnest intent to keep these products out of the hands of kids. We'll continue to ensure that the companies making and selling these products are doing their part to reverse this epidemic and we'll hold accountable those that don't take this responsibility seriously.

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.

For more information:
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use

Protecting American Families: Comprehensive Approach to Nicotine and Tobacco

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

Media Inquiries: Michael Felberbaum, 240-402-9548; [email protected]
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration