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FDA Panel Sends Mixed Signal On The Future Of Big Tobacco’s Heat-Not-Burn Technology


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Steve Birr Vice Reporter
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An advisory panel of the U.S. Food and Drug Administration sent mixed signals Thursday on the health consequences of an alternative smoking technology.

The health agency’s Tobacco Products Scientific Advisory Committee held a two day hearing this week on the safety claims made by Philip Morris International regarding their heat-not-burn product IQOS, which the company hopes will soon be approved for sale in the U.S. through a partnership with Altria, reports Reuters.

The panel rejected research from PMI showing that smokers who exclusively switch to IQOS drastically reduce their risks for developing tobacco related diseases, while simultaneously endorsing claims made by PMI that their device “significantly” slashes a user’s exposure to “harmful chemicals.”

The hearing focused on PMI’s Modified Risk Tobacco Product (MRTP) application, submitted to the FDA in Dec. 2016 and accepted for review in May, which will determine if the IQOS can be marketed as a safer alternative to smoking. The conclusions of the panel will serve to inform FDA officials currently reviewing the IQOS before a final decision is made regarding approval of the MRTP application.

FDA regulators can choose to disregard the recommendations of the panel.

The advisory panel ultimately believes the FDA should not allow the IQOS to be marketed as a reduced-risk product, voting unanimously that PMI failed to prove the device will cut the risks of developing tobacco-related illnesses or shrink the number of annual deaths attributed to smoking. They also voted 5-4 against claims that using IQOS is healthier than continuing to smoke combustible cigarettes.

The panel voted 8-1, however, that PMI has proven that “switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

Unlike a traditional e-cigarette, which vaporizes nicotine fluid, the IQOS heats tobacco leaves. Users insert sticks resembling short cigarettes into the device, which heats a concentrated dose of tobacco, eliminating the harmful combustion process of cigarettes.

PMI’s IQOS debuted in Japan last year before being introduced in additional countries. A recent report from Japan Tobacco shows the technology is causing cigarette sales to tumble at an unprecedented pace. Cigarette sales for Japan Tobacco experienced an 18 percent drop in December, an increase from previous months, showing sustained consumer interest in the heat-not-burn products.

Public health experts say the unprecedented success of heat-not-burn products in Japanese and European markets show the promising impact the technology could have on reducing global smoking rates. The company estimates roughly 4 million former smokers in 30 different markets across the world are actively using the product.

PMI presented research to the FDA showing the IQOS could similarly shake-up the domestic tobacco market. They argue that if only 15 percent of the current adult smoking population in the U.S. completely transitioned from combustible cigarettes to the IQOS, roughly 90,000 smoking-related deaths could be avoided over 20 years.

Despite the FDA panel’s rulings against the IQOS, their endorsement of claims it drastically reduces exposure to harmful chemicals leaves hope that FDA regulators could give the device a favorable ruling.

It is not clear when the FDA will make a final decision regarding the IQOS, but an announcement is expected in the coming months.

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