Remarks by Dr. Sharpless, Acting Commissioner of Food and Drugs, on the 10th Anniversary of the Tobacco Control Act June 24, 2019

Speech | In Person

• Speech by: Norman E. "Ned" Sharpless, MD ; Acting Commissioner of Food and Drugs - Food and Drug Administration

White Oak, MD

(Remarks as prepared for delivery)

Thank you, Mitch. And thanks to all of you for having me join today’s special event commemorating the 10th anniversary of the Tobacco Control Act.

When I realized I had this once-in-a-lifetime chance to serve as the Acting FDA Commissioner, the opportunities with regard to tobacco control were immediately top of mind.

I have my own long history with tobacco products.  First, like nearly all Americans, I have lost family members to tobacco associated disease.  Given tobacco’s primary role in so many common diseases, this is not a surprise.

As a cancer doctor, I have had the privilege of caring for many patients with tobacco-associated diseases. 

Even today, I can close my eyes and see the face of my first patient in medical school. 

As early first year students, we were sent from the classroom over to the inpatient wards to practice our history and physical exam (called an ‘H&P’) on real, actual patients. 

I recall donning my new white coat, and going over with my shiny new stethoscope to examine this lovely genetleman from Eastern NC. 

This great guy, who’d been healthy his whole life, but now was rapidly dying from small cell lung cancer.  One of the diseases most strongly associated with long-term cigarette smoking. 

Even as his life was slipping away to cancer, he agreed to have med students like me come over and learn from him, so that future patients would get better care.

Think of that, my first patient in med school, dying of a highly lethal disease that practically did not exist before the days of inhaled tobacco. 

It kills 25K Americans per year now, but was unheard of before people smoked. 

That patient and that epidemiology left an indelible mark on my career.

I have thought of his story often over the years, and found the memory motivating.

In fact, the research lab I ran in academia eventually came up with a new type of therapy being developed today for patients with that very same terrible type of cancer. 

You see, as a cancer researcher and Director of the NCI, I have dedicated my life to reducing the public health burden and suffering caused by cancer. 

And given those roles, I am well aware of the staggering toll inflicted on the public health by tobacco products, which cause cancer, heart disease, stroke, emphysema and many other common medical problems.

Given this burden, I see the FDA’s regulation of tobacco products as one of our greatest public health challenges, but also one of our greatest opportunities at the FDA. 

As we tighten tobacco control, we are having an immense impact on the health of Americans, given that tobacco use remains the leading cause of preventable disease and death in the United States.

Cigarette use has declined significantly in the last decade, but clearly we still have a long way to go.  There are still over 30 million Americans who smoke, there are still about 500,000 American deaths per year from tobacco-associated diseases.

You will hear from Mitch about the strong progress of the Center for Tobacco Products in its first decade of existence.  Undoubtedly, the FDA’s impact during this period has been extraordinary.

Whether it’s science, compliance and enforcement, regulation, communication and education, or management, each and every one of you have contributed to significant and substantial regulatory actions that are changing the tobacco landscape.

These past 10 years serve as an impressive foundation to what I know lies ahead.

Before I joined FDA as Acting Commissioner, Dr. Scott Gottlieb announced a groundbreaking plan for tobacco and nicotine regulation.

From this, FDA published a historic ANPRM to explore a product standard that would ensure that the only cigarettes available on the market could no longer create or sustain addiction.

This vision is remarkable and one I wholly inend to advance for as long as I am at FDA.

But while we have made real progress against the older foe of ‘combustible’ cigarettes and other traditional tobacco products, we also have to acknowledge the emergence of a new, very worrying problem in American life:  the explosion of children using of e-cigarettes.

As a long-time cancer researcher, I will concede that e-cigarette products have some value in helping addicted adult smokers transition away from combustible tobacco.  And, if an adult smoker can completely switch to an e-cig, the exposure to toxins is likely to be lower than from a traditional cigarette.

Having said that, though, these products are not safe, and I don’t think any of us envisioned how these products would take-off with children, in high schoolers and even middle schoolers. 

We now know that much of this rapid increase in youth use is related to unscrupulous marketing of these products to kids.

Mark my words: the FDA will not stand for this.

Through compliance, education and enforcement, we will continue to take decisive action to address and mitigate the epidemic of youth e-cigarette use.

We must set in place the policies and programs necessary to keep dangerous tobacco products out of the hands of America’s kids.

We cannot allow the next generation of young people to become addicted to nicotine.

And that is why this epidemic of kids’ use of e-cigarettes is of such grave concern to me, and, I know, to all of you.

I don’t need to tell you that your work is challenging.

But what I do want to reiterate is that this important work will continue to be advanced throughout my tenure at the FDA.

Please know that you have unwavering support from me, and also Secretary Azar and Deputy Secretary Hargan for these vital regulatory initiatives.

10 years is a notable achievement. And it is clear we are on the right track to reducing the public health burden caused by tobacco products.

I commend each and every one of you on your commitment to public health, and your drive to continue to improve lives for generations to come.

Take some time today to reflect on how much has been done, but also realize that these first 10 years are just the beginning.

Thank you.