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.
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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.
“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