iQOS heat-not-burn electronic tobacco product doesn’t reduce health risk, FDA says

pharmafile | January 26, 2018 | News story | Medical Communications, Sales and Marketing FDA, Philip Morris, iQOS, pharma, smoking, tobacco 

An advisory panel of the FDA has judged that US tobacco firm Philip Morris International (PMI) has not been able to prove that its new iQOS electronic tobacco device can reduce the risk of smoking-related diseases, and thus should not be able to make such a claim.

iQOS is the result of $3 billion worth of investment to counteract the decline of tobacco sales as consumers become more aware of the health risks of smoking. The sleek device, built to entice and present a brand that is a world away from traditional tobacco products, heats but does not burn tobacco sticks, and on this basis PMI argues that it lowers the risk of harm and could potentially save lives.

The panel did not agree, voting unanimously, minus one abstention, also voting 5-4 to reject the claim that iQOS is less risky than cigarettes. However, it did agree with the claim that use of the product exposes users to less harmful chemicals than that of cigarettes, with PMI’s data showing an overall exposure of 95%.

However, these votes are only advisory in nature, and as such are not legally binding. Analysts believe that PMI’s request for US approval will eventually be granted by the regulator. The product is already in use by around four million people outside the US.

While there is no timeframe set for a decision, the FDA is expected to pass a final judgement on whether iQOS can be sold on the US market in the next few months, when it will also decide whether to authorise the modified-risk claims.

Matt Fellows

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