Introduction
• Swedish Match USA, Inc., a subsidiary of Philip Morris International Inc. (PMI), has presented to the Tobacco Products Scientific Advisory Committee (TPSAC) as part of the FDA’s review process.
• The company aims to renew its Modified Risk Tobacco Product (MRTP) status for General Snus and expand the usage of its reduced-risk claims.
• This renewal seeks to reach more legal-age smokers and encourage them to switch to less harmful alternatives.
Background
• First Authorization (October 2019):
Swedish Match was the first company to receive a modified risk claim from the FDA. The current authorization allows Swedish Match to state:
• “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
• This claim is currently only available on the General Snus website.
• General Snus Overview:
General Snus is a smokeless, air-cured, non-fermented tobacco product traditionally produced in Sweden.
The MRTP renewal includes eight varieties available in the U.S. for over a decade:
1. General Snus Original (pouch)
2. General Snus Original (loose)
3. General Snus White (pouch)
4. General Snus Mint (pouch)
5. General Snus Wintergreen (pouch)
6. General Snus Mini Mint (pouch)
7. General Snus Classic Blend (pouch)
8. General Snus Nordic Mint (pouch)
Renewal Objectives
1. Expanded Marketing Channels:
Swedish Match is requesting approval to display reduced-risk claims in additional channels, including:
• Point-of-sale displays
• Direct mail campaigns targeted at age-verified consumers
2. Real-World Evidence:
The company provided evidence demonstrating:
• Effective harm reduction for individual tobacco users
• Overall health benefits for the population
Meeting Highlights
• Presentation:
Representatives from Swedish Match engaged with TPSAC members on scientific, technical, and consumer communication topics.
• The company highlighted its responsible marketing practices.
• Research demonstrated low usage among unintended populations.
• Statements from Swedish Match Leadership:
• Gerry Roerty, General Counsel:
• Emphasized the importance of the FDA’s strategic plan to eliminate smoking-related diseases and deaths.
• urged the committee to support the renewal of the modified risk claim to advance public health.
• Stacey Kennedy, President, Americas Region & CEO of PMI’s U.S. Business:
• Criticized misinformation surrounding smoke-free products, which prolongs cigarette use.
• Reaffirmed the company’s commitment to a cigarette-free America through science-driven policies.
PMI and Swedish Match: A Partnership for Change
• Acquisition:
In 2022, PMI acquired Swedish Match to combine expertise and lead innovation in oral nicotine delivery.
• Investments:
Since 2008, PMI has invested over $12.5 billion to develop, scientifically validate, and market smoke-free alternatives.
• Vision:
PMI aims to transition all smokers away from cigarettes to scientifically substantiated smoke-free products, accelerating the end of cigarette use worldwide.
Conclusion
• Swedish Match’s renewal submission underscores its commitment to public health and reducing harm.
• By expanding its marketing reach and continuing to provide scientifically supported products, Swedish Match seeks to contribute significantly to a cigarette-free future.
