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The FDA Authorizes the Marketing of IQOS as a Modified Risk Tobacco Product

Following a lengthy approval process which started four years ago, Altria Group, Inc. (Altria) (NYSE: MO) has announced that the U.S. Food and Drug Administration (FDA) has authorized the marketing of their IQOS tobacco heating device, as a modified risk tobacco product.

Diane Caruana

July 30, 2020

In December 2016, Philip Morris International (PMI) had submitted a Modified Risk Tobacco Product (MRTP) application with the FDA’s Center for Tobacco Products, for its Heat Not Burn device: iQOS.

The initial FDA panel had not agreed that the device reduced the risk of smoking related diseases, however they did agree that using iQOS instead of regular cigarettes, would significantly reduce a person’s exposure to harmful chemicals.

The iQOS device, is a smokeless alternative to combustible cigarettes which 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 the iQOS device is switched on.

When the iQOS application was first reviewed, an FDA panel had voted to reject over a million pages of evidence, dismissing PMI’s claim that iQOS is a safer alternative to tobacco. Additionally, Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) had sent a letter addressed to then FDA Commissioner Scott Gottlieb, urging him to deny the MRTP application for iQOS.

Meanwhile, in April 2019, the FDA authorized the IQOS PMTAs and in the following months, PM USA started launching the device across the US, starting with Atlanta, followed by Georgia, Richmond and Virginia.

IQOS to be marketed as a modified risk product

Subsequently earlier this month, Altria Group announced that the FDA has authorized the marketing of IQOS as a modified risk tobacco product with a reduced exposure claim. “We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product. This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS and this decision is an important step for adult smokers. Our 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future as we develop our portfolio of FDA-authorized, non-combustible products and actively switch adult smokers to them,” said Billy Gifford, Chief Executive Officer of Altria.

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