Swedish Match USA, Inc. Presents to U.S. Food and Drug Administration Advisory Committee to Renew Modified Risk Claim for General Snus

• A pioneer in modified risk products, Swedish Match was the first company to receive a modified risk marketing claim and is the first to advance through the FDA renewal process
• Swedish Match presented real-world evidence that shows the claim is delivering on its promise to both reduce harm to individual tobacco users and benefit the health of the population as a whole and should be renewed
• Swedish Match also asked the agency to consider adjusting the use of the claim to help switch more smokers and smokeless tobacco product consumers

Experts from Swedish Match USA, Inc., an affiliate of Philip Morris International Inc. (NYSE:PM) (PMI), presented to the Tobacco Products Scientific Advisory Committee (TPSAC) on June 26, 2024. The committee, comprised of independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration's (FDA) Center for Tobacco Products.

The half-day meeting was part of the FDA's review of Swedish Match's request to continue marketing General Snus products in the U.S. as Modified Risk Tobacco Products (MRTPs), and to expand permitted use of the reduced risk claim to reach, and transition, more legal-age smokers away from cigarettes.

Initially granted by FDA in October 2019, Swedish Match can communicate to legal age consumers that "Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis." Currently that message is accessible only on the General Snus website.

Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.

In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.

"As FDA's Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation," Gerry Roerty, General Counsel for Swedish Match, USA, Inc. said to committee members. The Center's mission is to make smoking-related disease and death a part of America's past and "today, together, we can meaningfully advance that goal," Roerty told committee members.

During the meeting, representatives from Swedish Match and committee members discussed a range of scientific, technical, and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented evidence and research demonstrating low levels of use by unintended populations.

General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is non-fermented, and air cured. The modified risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade, and include:

• General Snus Original (pouch)
• General Snus Original (loose)
• General Snus White (pouch)
• General Snus Mint (pouch)
• General Snus Wintergreen (pouch)
• General Snus Mini Mint (pouch)
• General Snus Classic Blend (pouch)
• General Snus Nordic Mint (pouch)

Stacey Kennedy, President, Americas Region & CEO of PMI's U.S. business said: "We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science." She continued, "America's 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified risk authorization."

In 2022, PMI acquired Swedish Match – a leader in oral nicotine delivery – creating a global smoke-free champion. Our ambition is that all those who would otherwise continue smoking abandon cigarettes and switch completely to scientifically substantiated smoke-free products as soon as possible. Regulatory policies and decisions can accelerate the speed and magnitude of this historic change.

Since 2008, PMI has invested over $12.5 billion to develop, scientifically substantiate, and commercialize innovative smoke-free products for adults who would otherwise continue to smoke, with the goal of ending the sale of cigarettes.

Note to the editor

The General Snus products were first authorized as "appropriate for the protection of the public health" through the premarket tobacco product application process in 2015 following a PMTA submission earlier in that same year.

Since then, Swedish Match USA, Inc., has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.

Philip Morris International: Delivering a Smoke-Free Future

Philip Morris International (PMI) is a leading international tobacco company, actively delivering a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector. The company's current product portfolio primarily consists of cigarettes and smoke-free products. Since 2008, PMI has invested over $12.5 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke, with the goal of completely ending the sale of cigarettes. This includes the building of world-class scientific assessment capabilities, notably in the areas of pre-clinical systems toxicology, clinical and behavioral research, as well as post-market studies. In 2022, PMI acquired Swedish Match – a leader in oral nicotine delivery – creating a global smoke-free champion led by the companies' IQOS and ZYN brands. The U.S. Food and Drug Administration has authorized versions of PMI's IQOS devices and consumables and Swedish Match's General Snus as Modified Risk Tobacco Products. As of December 31, 2023, PMI's smoke-free products were available for sale in 84 markets, and PMI estimates that approximately 33 million adults around the world use PMI's smoke-free products. Smoke-free business accounted for approximately 37% of PMI's total full-year 2023 net revenues. With a strong foundation and significant expertise in life sciences, PMI announced in February 2021 its ambition to expand into wellness and healthcare areas and, through its Vectura Fertin Pharma business, aims to enhance life through the delivery of seamless health experiences. For more information, please visit www.pmi.com and www.pmiscience.com.

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