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Big Tobacco’s Bet On Smoking Alternative May Still Pay Off With The FDA

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Steve Birr Vice Reporter
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The U.S. Food and Drug Administration could still give Philip Morris International’s smoking alternative a reduced-risk label after a panel of experts agreed the device slashes exposure to dangerous chemicals.

The FDA’s Tobacco Products Scientific Advisory Committee rejected the majority of health claims made by Philip Morris International (PMI) Thursday regarding their heat-not-burn technology IQOS. A vote endorsing claims that the new smoking alternative “significantly” reduces exposure to “harmful chemicals,” however, leaves the door open for PMI to secure a reduced-risk label from the FDA, reports MedPage Today.

The committee hearing last week 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 and many public health experts focused on harm reduction agree that they should.

“The company showed beyond any reasonable doubt that switching from cigarettes to IQOS would give reductions of 90 percent or more in exposure to the most important toxins,” Clive Bates of Counterfactual, a public interest consultancy and advocacy group, told The Daily Caller News Foundation. “The committee would need some bizarre and implausible theory of the human body for such exposures not to translate to reduced risk of harm and serious disease.”

The advisory panel ultimately believes the FDA should not allow the IQOS to be marketed as a reduced-risk product, voting unanimously Thursday 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, “switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

“My main concern is that a committee like this just functions as a pedantic obstruction to consumers getting truthful information that could be life-saving if they act on it,” Bates told TheDCNF. “I don’t think the committee serves any useful purpose and is mostly engaged in anti-tobacco virtue signalling with little apparent concern for the welfare of smokers, the people actually at risk.”

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.

The device is proving wildly popular overseas, directly fueling an 18 percent drop in annual cigarette sales in Japan after little more than a year on the market.

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.

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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