Home Politics America US Senate Democrats urge FDA to reject iQOS MRTP application

US Senate Democrats urge FDA to reject iQOS MRTP application

A number of Democratic Senators are asking the US Food and Drug Administration (FDA), to reject an MRTP application by Philip Morris International (PMI) for its iQOS device.

Diane Caruana

February 19, 2018

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

The FDA panel did not prove 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.

Subsequently, last month an FDA panel reviewed the iQOS application, and voted to reject over a million pages of evidence, dismissing Philip Morris International’s claim that their iQOS heated tobacco product is a safer alternative to tobacco.

This vote is not the final act in determining the fate of the MRTP application for iQOS, and the FDA isn’t obliged to follow the panel’s recommendations. The agency can be expected to take a formal and final decision in the coming months.

Democrats against iQOS

Then, last Wednesday, Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) sent a letter addressed to the FDA Commissioner Scott Gottlieb, urging him to deny the MRTP application for iQOS.

Dr. Farsalinos keeps pointing out that scientific data does indicate that the products are significantly safer than regular cigarettes.

The letter which was also signed by eight other Democrats, based its position on the fact that the FDA’s Committee panel had not proven that the device reduced the risk of smoking related diseases, even though the board did agree that using iQOS instead of regular cigarettes, would significantly reduce a person’s exposure to harmful chemicals.

“Many of us wrote to you in October urging a strict adherence to the Tobacco Control Act’s statutory requirements when evaluating applications for [modified risk tobacco product] claims,” wrote the Senators. “Such thorough review is especially critical given the tobacco industry’s deceitful history of marketing products under the guise of lower risk.”

Scientific studies do indicate that iQOS is safer than regular cigarettes

On the other hand, in discussing recent studies looking at the relative risks of HnB products, public health and anti-smoking expert Dr. Konstantinos Farsalinos keeps pointing out that scientific data does indicate that the products are significantly safer than regular cigarettes.

Read Further: The Hill