How FDA is Regulating E-Cigarettes

How FDA is Regulating E-Cigarettes

July 11, 2019 Off By administrator

By: Ned Sharpless, M.D., Acting Commissioner

Ned Sharpless, M.D.

When I was Director of the National Cancer Institute (NCI), I would be frequently asked “What topic in cancer research and cancer care keeps you up at night?” I always answered this question the same way: “tobacco control in the era of e-cigarettes.”

On the one hand, as someone trained in internal medicine and oncology, I am all too familiar with the devastating impact of combustible cigarettes on the public health: The 480,000 deaths per year in the U.S. from tobacco-associated cancers, emphysema, heart disease, stroke and the 34.3 million Americans who still smoke combustible cigarettes despite decades of efforts to help them quit. So, any product that can diminish the use of combustible cigarettes substantially has to be considered of enormous potential value. Are e-cigarettes that product? Well, given that most e-cigarette users continue to smoke cigarettes, the answer is not clear. Though there are some data, both epidemiological and from direct clinical trials, that some electronic nicotine delivery systems (ENDS, which includes products known as “e-cigarettes”) can reduce the use of combustible cigarettes and may be less harmful than traditional cigarettes.

What is clear is the explosion of use and nicotine addiction in children driven by the advent of ENDS, especially the pod-based products such as JUUL. After years of witnessing a steady decline in the use of tobacco products by children and young adults, we are now seeing a rapid resurgence of the use of tobacco products in these populations. There are many unanswered questions about ENDS: we do not yet know how dangerous these products are when used over the long-term; we do not know if they are truly effective at helping addicted adults quit smoking traditional cigarettes, or even if some types of ENDS are less harmful than traditional cigarettes; we do not know to what extent they can serve as a “gateway” to the use of combustible cigarettes. Clearly, some of the rapid rise in youth use of these products has resulted from irresponsible practices of the manufacturers, who have targeted kids in their marketing of these products. And while ENDS products appear to hold some promise in helping addicted adult smokers transition away from combustible tobacco to a potentially less harmful form of nicotine delivery, these products are not safe, and we cannot allow the next generation of young people to become addicted to nicotine.

So, it’s clear why this topic is a complicated one with many unknowns. There is great potential to significantly reduce the national burden of cancer and other diseases if we can help addicted smokers quit what is perhaps the most dangerous product that is mass marketed in America today, but there is…

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