Remarks from the 19th Annual Marshall J. Seidman Lecture Series.
A travesty on top of a travesty.
November 13, 2019
This is a burgeoning epidemic. Like all emerging epidemics, to get in front of it, it’ll require dramatic action. Actions in the face of epidemics of addiction have often been too incremental, only to see the epidemic continue to expand beyond our grasp. We can’t make that mistake here.
We need to intervene with steps that are robust enough to get fully in front of this epidemic. In my view, that requires us to sweep the market of all of the cartridge-based e-cigarette products in their entirety – this includes Juul, but also other pod-based products like NJOY, Blu, and Vuse.
The good news is that we’ve made a lot of progress since the landmark Surgeon General’s Report on Smoking and Health in 1964. But the 50th anniversary of the report showed that tobacco use, primarily smoking, still causes 480,000 American deaths every year. At the current rate, from the release of that report in 2014 through the mid 21st century, we’re on track to suffer 17.28 million avoidable premature deaths in the United States as a result of tobacco use. The death and disease from tobacco remains one of this nation’s greatest public health burdens.
For all of these reasons, FDA’s regulatory efforts are needed more today than ever before.
On the one hand we have a tremendous opportunity to continue to accelerate declines in the use of combustible tobacco products. On the other hand, the rates of use of e-cigs among kids creates significant risk for the future and it requires our strong and immediate intervention.
We know that the overwhelming amount of tobacco-related disease in the U.S. is caused by highly addictive combustible cigarettes. The Tobacco Control Act had many modern regulatory elements to address these perils. It enabled a role for product regulation to reduce the risks posed by cigarettes. At the same time, it envisioned a path for products that could help currently addicted adult smokers who still wanted to use nicotine, to have access to products that didn’t require combustion and didn’t have all of the health risks associated with cigarettes. The idea of harm reduction is a modern concept in FDA regulation. And the Tobacco Control Act embedded these principles in a contemporary regulatory framework for the first time.
To pursue our over-arching goal of accelerating the declines in death and disease from tobacco, on July 28, 2017 I announced FDA’s comprehensive approach to regulating tobacco products. Our approach placed nicotine, and the issue of addiction, at the center of our efforts. We envisioned a world where cigarettes can no longer create or sustain addiction, and where adults who still want nicotine can get it from alternative and less harmful sources, including innovation in nicotine replacement therapies sold as over-the-counter drugs for aiding cessation.
A centerpiece of this comprehensive regulatory plan was acknowledging that nicotine, while highly addictive, is delivered through products that exist on a continuum of risk. And it’s the delivery mechanism – and not the nicotine itself – that was truly the issue at-hand.
If young people getting addicted to combustible cigarettes is the main culprit that sustains the cycle of cigarette-caused disease and death, then our answer was really rather clear.