Business Wire

Philip Morris International Announces U.S. Food and Drug Administration Authorization For Sale of IQOS in the United States

Share

The U.S. Food and Drug Administration (FDA) today confirmed that IQOS, Philip Morris International’s electrically heated tobacco system, is appropriate for the protection of public health and has authorized it for sale in the United States. FDA’s decision follows its comprehensive assessment of PMI’s premarket tobacco product applications (PMTAs) filed with the Agency in 2017.

Unlike cigarettes, the IQOS system heats — but does not burn — tobacco. It is the first electrically heated tobacco product to qualify for sale in the U.S. pursuant to the 2009 law that empowers FDA to regulate tobacco products, including through oversight of innovative products.

Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said:

“The FDA’s decision to authorize IQOS in the U.S. is an important step forward for the approximately 40 million American men and women who smoke. Some will quit. Most won’t, and for them IQOS offers a smoke-free alternative to continued smoking. In just two years, 7.3 million people around the world have abandoned cigarettes and switched completely to IQOS. Today’s decision by FDA makes this opportunity available to American adult smokers. All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and intensive scientific validation. FDA’s announcement is a historic milestone.”

He added, “The order sets out clear commercialization guidelines, including marketing requirements, that maximize the opportunity for adults to switch from cigarettes, while minimizing unintended use. We fully support this objective. FDA has set a high standard and we look forward to working with them to implement the order so that IQOS is reaching the right audience—current adult smokers.

PMI will bring IQOS to the U.S. market through an exclusive license with Altria Group, Inc., whose subsidiary Philip Morris USA has the market expertise and infrastructure to ensure a successful launch. PM USA is ready to deploy its initial lead market plans for IQOS.

PMI submitted a comprehensive body of scientific evidence in support of the PMTAs and of the parallel applications for IQOS as a “Modified Risk Tobacco Product”, which FDA continues to review.

Note to Editor

PMP SA submitted PMTA applications for IQOS and three HeatStick variants: Marlboro HeatSticksMarlboro Smooth Menthol HeatSticks; and Marlboro Fresh Menthol HeatSticks.

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 to 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, smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free IQOS product portfolio includes heat-not-burn and nicotine-containing vapor products. As of March 31, 2019, PMI estimates that approximately 7.3 million adult smokers around the world have already stopped smoking and switched to PMI’s heat-not-burn product, which is currently available for sale in 47 markets in key cities or nationwide under the IQOS brand. For more information, please visit www.pmi.com and www.pmiscience.com.

Contact information

Corey Henry
Philip Morris International Media Office
T. +1 (202) 679 7296
E. corey.henry@pmi.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

IFF to Webcast Fireside Chat at Stifel Virtual Cross Sector Insight Conference June 82.6.2020 22:15:00 CESTPress release

Regulatory News: IFF (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent and nutrition, today announced that the Company’s management will be participating in a fireside chat at the Stifel Virtual Cross Sector Insight Conference on Monday, June 8, 2020 at 4:00 PM ET. Investors may access the live webcast on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Welcome to IFF At IFF (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), we’re using Uncommon Sense to create what the world needs. As a collective of unconventional thinkers and creators, we put science and artistry to work to create unique and unexpected scents, tastes, experiences and ingredients for the products our world craves. Learn more at iff.com, Twitter , Facebook, Instagram, and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20200602005897/en/Contact information Micha

ZOOM International to Begin Doing Business As Elevēo2.6.2020 16:00:00 CESTPress release

ZOOM International a worldwide leader in omni-channel compliance recording, workforce optimization (WFO), and revenue protection software for contact centers will begin doing business solely as elevēo beginning June 2nd, 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200602005093/en/ For over 20 years, ZOOM International has been a leading workforce optimization software provider in the contact center industry. Very early on, we were approached to solve a compliance problem with call recording. We built a creative software solution in record time, and began a journey crossing continents, employing hundreds of colleagues, and eventually improving operations, compliance, and customer experience for thousands of customers in 94 countries via more than 550 channel partners in the communications industry. Over time we have earned an 88 NPS score from ZOOM International customers & partners for our world-class support and in

Dr Evidence (DRE), an AI-Enabled SaaS Healthcare Insights Company, Taps Industry Experts Joseph A. Boystak as Chairman of the Board and Ameet Nathwani, MD, as Chairman of its Newly Formed Medical Strategy Advisory Board2.6.2020 16:00:00 CESTPress release

DRE is pleased to welcome Joe Boystak as Chairman of the Board and Ameet Nathwani, MD, as Chairman of its newly formed Medical Strategy Advisory Board (MSAB). These enhancements to the Company reflect the expanded need for keen guidance in this unprecedented time of convergence between expert AI-enabled technology in healthcare and the exponential growth of clinical information. DRE is dedicated to applying sophisticated data science with advanced AI to generate quicker, deeper, more nuanced regulatory-grade scientific and clinical insights for the betterment of patient outcomes. Boystak is an experienced healthcare venture capitalist and senior healthcare investment banker having been Founding Managing Partner at Health2047 Capital Partners and Founding Managing Director, Global Life Sciences at Jefferies. He is CEO of Brightwaters Capital and is a serial co-founder/investor in biomedical, med tech, health information technology, and artificial intelligence companies with spinouts fro

Andersen Global Expands Presence in Qatar2.6.2020 15:30:00 CESTPress release

Andersen Global announced its collaboration with Doha-based tax firm MS Partner, adding depth to the organization’s presence in Qatar and expanding its global platform. MS Partner was founded in 2018 and includes two Partners and more than 10 professionals that specialize in providing tax services to a variety of international clients including individuals and companies – both private and public. MS Partner’s Chairman His Excellency Shaikh Sultan Bin Jassim Bin Mohammed Al Thani is a prominent business leader in the State of Qatar. “We value our clients and people, and maintain the highest of professional standards,” said Office Managing Director Manikandan Rajan. “We’ve watched Andersen Global grow regionally as well as globally, and the organization has set the standard for providing clients with best-in-class service in an independent and seamless manner. We look forward to working closely with our fellow collaborating firm in Doha, Al-Khalifa Law, as well as all the collaborating f

Pegasus Development AG: Pegasus Present Its New Brand Pegastril - Nuevo2.6.2020 15:06:00 CESTPress release

The coronavirus pandemic harbours the potential for enormous growth in specific industries. To that end, however, it's important to identify which markets will be dominant in the future. One of the key growth sectors is the production and distribution of disinfectants and associated technologies. Regardless of whether a cure for, or vaccine against, COVID-19 is developed, protection against viruses and bacteria has become incredibly important across the globe and will continue to be a concern going forward. This was one of the reasons why Pegasus Development AG decided to partner with the British disinfectant manufacturer Nuevo. One of the decisive factors choosing Nuevo was its highly competitive product, which is free from alcohol, animal products, perfume, essential oils or dyes. Furthermore, the product has already been tested according to the highest stipulations of the European standard EN 1276, is manufactured according to the latest regulations of the European Biocides Directiv

PVH Corp. Announces Leadership Update at Tommy Hilfiger and PVH Europe2.6.2020 15:00:00 CESTPress release

PVH Corp. (NYSE:PVH), owner of a portfolio of iconic brands including TOMMY HILFIGER and CALVIN KLEIN, announced today that Daniel Grieder is stepping down from his role of Chief Executive Officer, Tommy Hilfiger Global & PVH Europe after 23 years in various management roles within the organization, and will be leaving the company to pursue other interests. Martijn Hagman will succeed Grieder and become the new Chief Executive Officer, Tommy Hilfiger Global & PVH Europe, effective June 2, 2020. Hagman is currently Chief Operating Officer, Tommy Hilfiger Global & PVH Europe and Chief Financial Officer, Tommy Hilfiger Global, overseeing operations, finance, digital business transformation, technology, business development and the Tommy Hilfiger global sustainability program. He is a 12-year veteran of the Tommy Hilfiger leadership team and has been instrumental in Tommy Hilfiger’s impressive global expansion and the strategy that has led to PVH Europe’s consistent year-over-year growth.