FDA Should Approve Less Harmful Alternatives To Cigarettes

Airplane wrong week to quit smoking YouTube screenshot/Feureau

Alex Brill Resident fellow at the American Enterprise Institute
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Cigarettes are known killers, with nearly one in five deaths each year in the United States attributable to smoking. But there is a chance that U.S. smokers may soon be able to choose a less harmful alternative.

Later this week, the Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) will review an application for a new tobacco product that holds great promise for reducing the number of lives lost to cigarette smoking. The new product, IQOS, from Philip Morris International, heats tobacco up to 662 degrees Fahrenheit instead of burning it at 1300 degrees, as traditional cigarettes do. This type of technology, known appropriately as “heat-not-burn” (HNB), has been shown to produce lower levels of carcinogens than cigarettes but comparable levels of nicotine. In other words, HNB products represent an opportunity to reduce harm and fit squarely into the FDA’s new comprehensive approach to tobacco regulation. As FDA Commissioner Scott Gottlieb noted when he unveiled his agency’s new agenda, we need “a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.”

Cigarettes’ harmfulness is primarily due to the toxins and gases produced in combustion — that is, burning tobacco. As I have detailed, toxicological data on HNB products show substantially lower levels of harmful and potentially harmful constituents (HPHCs) compared to cigarettes. In addition, clinical studies comparing the effects of cigarettes and HNB products on smokers have demonstrated that exposure to HPHCs was greatly reduced for those who switched from cigarettes to HNB products.

A handful of HNB devices — including IQOS, Glo, and Ploom — are already available in other countries. Citizens of Japan, the UK, South Korea, Canada, and Switzerland, for example, are beginning to realize the benefits of this less harmful alternative to traditional cigarettes. The greenlight from regulators abroad should not supplant FDA’s investigatory work, but it does suggest that an important public health opportunity exists.

TPSAC members — health and science experts from various fields tasked with advising the FDA commissioner on the regulation of tobacco products — should back the approval of a product that would help switch people from cigarettes. With public health as the key objective and a desire to promote a transparent process with high clinical standards and a clear path, TPSAC should encourage the FDA to allow the marketplace to progress so that consumers can find better alternatives to the cigarettes that have held a virtual monopoly on the nicotine market for decades.

A positive recommendation from TPSAC would help advance the tobacco agenda Commissioner Gottlieb unveiled six months ago. As he said at the time, “It’s incumbent upon us as regulators to explore both the potential public health benefits and the risks of this new technology with an open mind. And I can assure you, from my discussions with the leadership of the Center for Tobacco Products, that FDA is bringing just that mindset to the task at hand.”

Clearly, the FDA is embracing the potential opportunities that new technologies in this field may offer to smokers while also taking seriously its responsibility to be rigorous in its evaluation.

Alex Brill is a resident fellow at the American Enterprise Institute.

The views and opinions expressed in this commentary are those of the author and do not reflect the official position of The Daily Caller.

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Alex Brill