“Following a rigorous science-based review through the pre-market tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the US market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes,” stated the FDA.

“While today’s action permits the tobacco products to be sold in the US, it does not mean these products are safe or ‘FDA approved’,” added the agency.

iQOS, is an HnB device that works by heating tobacco leaves known as Heets or HeatSticks. These refills which look like short cigarettes, must be inserted into the device and are heated up once iQOS is switched on. They are sold by Philip Morris under the Marlboro brand for approximately the same price as their combustible counterparts.

A long application process

Research has indicated that IQOS emits substantially lower levels of carbonyls than a regular cigarette but higher levels than an e-cigarette.

During a press release in December 2016, Philip Morris International (PMI) had announced that it had submitted a Modified Risk Tobacco Product (MRTP), application with the FDA’s Center for Tobacco Products for the product.

A bit over a year later, on the 24th of January 2018, the FDA’s Tobacco Products Scientific Advisory Committee had met to discuss this MRTP application for the IQOS system with Marlboro Heatsticks, the IQOS system with Marlboro Smooth Menthol Heatsticks, and the IQOS system with Marlboro Fresh Menthol Heatsticks.

Tobacco harm reduction experts are pleased that smokers will have another safer alternative to choose from. Alex Clark, CEO of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), a nonprofit which champions tobacco harm reduction efforts, is amongst those who spoke in favour of the FDA’s decision. “CASAA supports the FDA’s decision to approve IQOS for market in the United States. It is vital that people who smoke are aware of and have access to non-combustible alternatives to cigarettes and that these products are enjoyable.”

HnBs contain less toxins than cigarettes but more than e-cigarettes

A recent study by renowned anti-smoking expert Dr. Konstantinos Farsalinos which analyzed and compared carbonyl emissions from an HnB device, an e-cigarette and a regular cigarette, concluded that the IQOS device emits substantially lower levels of carbonyls than a regular cigarette but higher levels than an e-cigarette.

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