“A historic public health milestone” — FDA authorises IQOS marketing as a Modified Risk Tobacco Product

PMI says the FDA decision serves as an excellent example of a cooperative approach to achieving a smoke-free future

In a landmark ruling, the US Food and Drug Administration (FDA) this week authorised the marketing of Philip Morris International’s (PMI) flagship smoke-free tobacco system IQOS as a Modified Risk Tobacco Product (MRTP).

The decision was based on a review of the scientific evidence submitted by PMI to the FDA in December 2016 to support its MRTP application. It follows the FDA’s April 2019 decision approving the commercialisation of IQOS in the US.

The FDA has approved the marketing of IQOS as a system that heats tobacco instead of burning it – a process which significantly reduces the production of harmful and potentially harmful chemicals.

The announcement builds on emerging scientific evidence and legitimises IQOS’s positioning as a better alternative for adults who would otherwise continue smoking. IQOS is the first and only electric nicotine product to have been granted marketing orders through the FDA MRTP process.

According to PMI, scientific studies have demonstrated that making the switch from traditional cigarettes to the IQOS system decreases the body’s exposure to dangerous substances while smoking.

A smoke-free future: PMI has invested US$6 billion in the scientific research, development and commercialisation of its growing portfolio of advanced smoke-free products
Tobacco meets technology: IQOS significantly reduces harmful and potentially harmful chemicals through its ‘heat not burn’ system

“The FDA’s decision is a historic public health milestone,” said Philip Morris International CEO André Calantzopoulos. “Many of the tens of millions of American men and women who smoke today will quit — but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.”

Calantzopoulos added that IQOS, PMI’s leading reduced risk product (RRP), functions differently from conventional cigarettes and so its marketing and regulation should reflect that. “IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognised,” he said.

PMI estimates that as of 31 March 2020, approximately 10.6 million adult smokers worldwide have already switched to IQOS. According to Calantzopoulos, the FDA decision serves as an important example of how businesses, governments and public health institutions can work together to regulate smoke-free alternatives.

He said: “Now — more than ever — there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future. The FDA’s decision provides an important example of how governments and public health organisations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.

“We believe that this decision can help to further accelerate the transition of US adults away from cigarettes,” added  Calantzopoulos. “We, along with our [US] licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.”

PMI aims to rapidly shift adult smokers to a smoke-free lifestyle through innovations such as the IQOS system

What does a smoke-free future look like for PMI? According to Calantzopoulos, it’s all about innovation and collaboration. He said: “Harnessing innovations like IQOS to dramatically speed up the decline in cigarette smoking is the opportunity of this century. Comprehensive, science-based regulation can help to rapidly shift adult smokers who would otherwise continue smoking to better options, while simultaneously guarding against unintended consequences.

“Today’s decision is a result of our ongoing commitment to put science at the forefront as we continue on our quest to replace cigarettes with smoke-free alternatives as quickly as possible.”

This week’s landmark decision in the US will add further interest to Philip Morris International’s (PMI) presence at the inaugural Moodie Davitt Virtual Travel Retail Expo. The company will focus on its successful reduced-risk products as a Platinum Partner at the event.

The Moodie Davitt Virtual Travel Retail Expo has attracted tremendous support from retailers, brands and airports with a string of further major announcements to be made in coming days. For exhibitors, the event features a range of Virtual Stands at different price levels, each offering a high-class digital experience, complimentary Expo Guide advertising, and unrivalled visibility to the global travel retail community.

Click here to view The Moodie Davitt e-Zine from September 2018, which featured an on-location report from PMI’s extraordinary research, development and scientific centre, Cube, in Neuchâtel

 

Food & Beverage The Magazine eZine