Was Juul marketing to teenagers? What ethical dilemmas are present? Did they do the right things to reduce use by teens/young people?

ARTICLE TO BASE THINGS OFF OF:

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.

We saw an opening to push a generational shift in the deadly course caused by tobacco. And we've seized it.

Our comprehensive tobacco plan to combat the ill effects of smoking was founded on a central animating principle. That what primarily causes death and disease from tobacco use isn't the nicotine in these products. It's the act of lighting tobacco on fire to free that drug for inhalation.

While it's the addiction to nicotine that keeps people smoking, it's primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people.

This fact represents both the biggest challenge to curtailing cigarette addiction and also holds the seeds of an opportunity that's a central construct for our actions.

E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them. So, we set out on a new rulemaking process that seeks to regulate the nicotine levels in combustible cigarettes to render them minimally or non-addictive. That process is well underway.

And at the same time, we're developing a path to properly regulate non-combustible forms of nicotine delivery, like electronic cigarettes, that may be an alternative for adults who still want to get access to satisfying levels of nicotine, without all the risks associated with lighting tobacco on fire.

We saw an important opportunity. We saw a chance to leverage the potential benefits of new and non-combustible technology to allow more adults to get nicotine from sources that could pose a lot less harm than smoking cigarettes. We continue to believe in this central concept.

But let me be clear that nicotine isn't a benign substance. This is especially true when it comes to children, and the effects that nicotine has on a developing brain. That's why we need a strong regulatory process that puts these new products through an appropriate series of regulatory gates.

We need a regulatory process that requires product applications to show that the marketing of the product is appropriate for the protection of the health of the overall population. And we need a regulatory process that keeps these same electronic cigarette products out of the hands of youth.

This is our current policy framework to fulfill a central premise of our public health mandate.

We need to make sure that we properly evaluate the net public health impact of products like e-cigs before they get marketing authorization from the FDA and that these products meet their regulatory responsibilities. Such products may still pose health risks, including possibly releasing some chemicals at higher levels than conventional cigarettes, and these potential risks require closer scrutiny.

But since electronic nicotine delivery system (ENDS) products had only been recently brought under FDA's regulatory jurisdiction, few of the foundational rules and guidance documents for defining and clarifying the premarket authorization process for such products had been established at the time I joined the FDA 17 months ago. So, to create this regulatory framework for how we'd properly evaluate the electronic nicotine delivery products, we've committed to the development of guidance and regulations, including product standards, that will better spell out the rules of the road. And we're making significant progress toward achieving these procedural goals.

If we succeed in our overall plan, the public health impact can dwarf anything else we're able to accomplish in any reasonable stretch of time. It can dwarf the introduction of any new medical technology. Analysis shows that our plan has the potential to drop smoking rates from the current 15 percent to as low as 1.4 percent. It can prevent more than 33 million people including children from becoming smokers; avoiding a lot of the death and disease that's going to be caused by cigarettes. Yet despite our progress, and these metrics, we find ourselves at a very challenging crossroads in the execution of this plan.

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.

This fundamental commitment is why FDA launched our Youth Tobacco Prevention Plan earlier this year.

That plan encompassed a series of actions to stop youth use of tobacco products, especially the rising use of e-cigarettes. Our Youth Tobacco Prevention Plan focuses on three key strategies. First, preventing youth access to tobacco products. Second, curbing the marketing of tobacco products aimed at youth. And finally, educating teens about the dangers of using any tobacco products.

Recognizing that our most immediate tool to address youth use is enforcement, this has been a cornerstone of our approach. And it's a tool that we'll continue to deploy, and with growing vigor, to directly address this challenge.

We've taken a series of compliance actions over the past year. In partnership with the Federal Trade Commission, we targeted misleadingly labeled or advertised e-liquids resembling kid-friendly foods like juice boxes, candy and cookies. Since then, the manufacturers, distributors, and retailers that were warned by the FDA have stopped selling products with the offending labeling and advertising. And, today, the FDA issued 12 warning letters to other companies that continue to advertise and sell the violative products. This includes several companies that are also cited by the FDA for illegally selling the products to kids.

We've also sharply expanded our enforcement against retailers who illegally sell e-cigarettes to kids.

This spring, we focused on sales of JUUL, issuing 56 warning letters and six civil monetary penalties to retailers as part of this effort. And, today, we're announcing that we're taking other, significant enforcement and compliance actions.

We're announcing the largest ever coordinated initiative against violative sales in the history of the FDA. This is the largest single enforcement action in agency history. It's aimed at retail and online sales of e-cigarettes to minors.

We sent more than 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors. In addition, we issued another 131 civil money penalties to stores that continued to violate the restrictions on sales to minors.

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.