NEW YORK (BUSINESS WIRE) Jul. 2020 — Regulatory News:
The US Food and Drug Administration (FDA) today authorized the marketing of IQOS , Philip Morris International’s (PMI) electronically heated tobacco system, as a modified risk tobacco product (MRTP). In doing so, the agency found that authorizing an exposure modification order for IQOS is adequate to promote public health.
- Today’s decision demonstrates that IQOS is a fundamentally different product and a better choice for adults who would otherwise continue to smoke,
- IQOS is the first and only electronic nicotine product to be issued marketing orders through the FDA’s MRTP process,
- The FDA authorized the marketing of IQOS with the following information:
- The IQOS System heats tobacco, but does not burn it,
- This significantly reduces the production of harmful and potentially harmful chemicals,
- Scientific studies have shown that completely switching from conventional cigarettes to the IQOS system reduces the exposure of the consumer’s body to harmful or potentially harmful chemicals,
- The agency concluded that the available scientific evidence shows that IQOS is expected to benefit the health of the population as a whole, taking into account both consumers of tobacco products and people who currently do not use tobacco products,
- The FDA decision contributes to increasing the emerging independent international scientific consensus that IQOS is a better option than continuing to smoke, and follows the April 2019 FDA decision authorizing the marketing of IQOS in the United States,
- The FDA decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to protect and promote public health,
- This decision follows a review of the extensive package of scientific evidence submitted by PMI to the FDA in December 2016 to support its MRTP requests.
Commenting on the FDA announcement, André Calantzopoulos, Executive Director of PMI, said:
«The FDA decision is a landmark public health milestone. Many of the tens of millions of American men and women who smoke today will quit, but many will not. Today’s decision makes it possible to inform these adults that, Switching completely to IQOS is a better option than continuing to smoke The FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.
IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as recognized by the FDA. Now, more than ever, there is an urgent need for a fundamentally different conversation about a cooperative approach to achieving a smoke-free future. The FDA decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes to promote public health.
We are excited that this important decision helps guide the choices of adult smokers in the United States. The best option for health is to never start smoking or stop smoking completely. For those who don’t quit smoking, the best they can do is switch to a scientifically based smoke-free product. As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers worldwide have already quit and switched to IQOS . We believe this decision can help further accelerate the transition of American adults away from cigarettes. We, along with our licensee Altria, are committed to monitoring unintended use and fully support the FDA’s approach to protecting youth.
Today’s decision is the result of our continued commitment to put science at the forefront as we continue in our quest to replace cigarettes with smoke-free alternatives as quickly as possible.
We look forward to working with the FDA to provide any additional information they may require in order to market IQOS with reduced risk statements.
Leveraging innovations like IQOS to dramatically accelerate the decline in cigarette smoking is the opportunity of this century. Comprehensive, science-based regulation can help quickly move adult smokers who would otherwise continue to smoke to better options, while protecting against unintended consequences. ”
Note to Editor
MRTP marketing orders were issued pursuant to a 2009 law that empowers the FDA to regulate tobacco products, including through oversight of innovative tobacco products.
PMI submitted MRTP requests for the IQOS device and three variants of HeatStick: Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks, and Marlboro Fresh Menthol HeatSticks .
On April 30, 2019, the FDA authorized IQOS for sale in the U.S. through the issuance of premarket tobacco marketing authorization orders that deemed the marketing of the product appropriate for the protection of the public health.
On March 30, 2020, PMI filed with the FDA a pre-marketing tobacco product supplemental application for the IQOS 3 tobacco warming device.
Philip Morris International: Delivering a smoke-free future
Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products for the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the United States. In addition, PMI ships a version of its IQOS Platform 1 device and its consumables authorized by the United States Food and Drug Administration to Altria Group, Inc. for sale in the US under license. PMI is building a future in a new category of smoke-free products that, while not risk-free, are a much better option than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific foundation, PMI aims to ensure that its smoke-free products meet the preferences of adult consumers and rigorous regulatory requirements. PMI’s portfolio of smoke-free IQOS products includes products that heat and don’t burn and steam products that contain nicotine. As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers worldwide have already quit and switched to PMI’s heated and non-burning product, available for sale in 53 markets in key cities. or nationally, under the IQOS brand. For more information, visit www.pmi.com and www.pmiscience.com .