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

Rhea-AI Summary

Swedish Match USA, affiliated with Philip Morris International (PM), has presented to the FDA's Tobacco Products Scientific Advisory Committee, seeking the renewal and expansion of its Modified Risk Tobacco Products (MRTP) claim for General Snus. Initially approved in 2019, Swedish Match now aims to broaden the claim's reach to more marketing channels, providing evidence of the product's reduced harm compared to cigarettes. The meeting on June 26, 2024, emphasized the public health benefits and responsible marketing practices. Swedish Match, acquired by PMI in 2022, is pushing for policy changes to aid the shift from cigarettes to smoke-free products.

Positive

• Swedish Match provided real-world evidence supporting the health benefits of General Snus compared to cigarettes.
• Expansion of the MRTP claim could increase market reach and potential sales of General Snus.
• Swedish Match's commitment to responsible marketing practices and low levels of use by unintended populations.

Negative

• The renewal process depends on FDA approval, which introduces regulatory uncertainty.
• Potential misinformation about smoke-free products may confuse consumers, affecting market perception and sales.

Financial Analyst

From a financial perspective, the renewal of the modified risk claim for General Snus could have significant implications for Swedish Match USA, now under Philip Morris International (PMI). The ability to market General Snus as a less harmful alternative to cigarettes can help the company capture a larger share of the legal-age smoker market. If the claim's use extends to additional marketing channels like point-of-sale displays and direct mail, this can lead to increased product visibility and ultimately, higher sales volumes.

This development aligns with PMI's long-term strategy of transitioning from traditional tobacco products to smoke-free alternatives, a pivot underscored by their $12.5 billion investment in related research and development. Such strategic moves are particularly noteworthy as they could potentially shift revenue streams from declining cigarette sales to these alternative products. For retail investors, this represents both a diversification of revenue and a hedge against future regulatory constraints on cigarettes.

However, it's essential to be cautious about the regulatory risks. Any adverse decision from the FDA could impair the revenue growth potential of these products. Investors should also consider the broader market reception and whether consumers will indeed switch from cigarettes to General Snus.

Market Research Analyst

For market dynamics, the modified risk claim renewal for General Snus is poised to create ripples in the tobacco and nicotine product landscape. This claim not only sets General Snus apart from traditional tobacco products but also positions it favorably against other reduced-risk alternatives. The presentation of real-world evidence showing a reduced harm profile is important for building consumer trust and can serve as a powerful marketing tool.

The ability to communicate health benefits via multiple marketing channels can significantly enhance consumer reach and engagement. This is vital in the context of the current misinformation landscape around smoke-free products, as reiterated by Stacey Kennedy, CEO of PMI's U.S. business. Broadening the scope of communication can also support PMI's goal to convert the remaining 28% of adult smokers to less harmful alternatives, thus expanding their customer base.

However, market penetration will depend on consumer education and behavioral shifts, which can be slow and require sustained efforts. Investors should be aware that while the current consumer trend is favorable, the competitive landscape remains challenging with other companies vying for the same market share.

Regulatory Affairs Expert

In the regulatory domain, Swedish Match’s proactive approach in renewing its modified risk claim demonstrates its commitment to operating within stringent U.S. regulatory frameworks. The FDA's approval process, including the Tobacco Products Scientific Advisory Committee's (TPSAC) involvement, adds a layer of scientific credibility to their claims. This not only enhances the product's market positioning but also provides a strategic edge in regulatory compliance.

The successful renewal of the MRTP status would have a dual benefit: it validates the product's safety profile and strengthens Swedish Match's lobbying capability for more relaxed marketing restrictions. This is particularly relevant as the regulatory landscape evolves, focusing more on harm reduction rather than total tobacco avoidance.

However, the complex and often slow regulatory processes can introduce uncertainty. Investors should consider the timeline for such approvals and the potential for regulatory shifts that could affect marketing strategies and product distribution.

• 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

STAMFORD, CT.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240701485978/en/

Philip Morris International

Media: Corey Henry

U.S.: +1 (202) 679-7296

Email: corey.henry@pmi.com

Source: Philip Morris International

FAQ

What did Swedish Match present to the FDA regarding General Snus on June 26, 2024?

Swedish Match presented real-world evidence to the FDA's Tobacco Products Scientific Advisory Committee, seeking renewal and expansion of its Modified Risk Tobacco Products claim for General Snus.

What is the Modified Risk Tobacco Products (MRTP) claim for General Snus?

The MRTP claim for General Snus allows Swedish Match to market the product as lower risk for mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis compared to cigarettes.

Why is Swedish Match seeking to expand its MRTP claim for General Snus?

Swedish Match aims to expand the MRTP claim to reach more marketing channels and transition more legal-age smokers from cigarettes to General Snus.

How does Swedish Match plan to market General Snus if the MRTP claim is renewed?

Swedish Match plans to use additional marketing channels such as point-of-sale displays and direct mail to age-verified consumers.

What are the potential benefits of renewing the MRTP claim for General Snus?

Renewing the MRTP claim could enhance public health by reducing smoking-related diseases and expanding the market reach of General Snus.