Swedish Match aims to renew and expand modified risk tobacco product status in US

Swedish Match USA, Inc., part of the Philip Morris International Inc. (NYSE: PM) family, made a significant presentation on June 26, 2024, to the Tobacco Products Scientific Advisory Committee (TPSAC) at the U.S. Food and Drug Administration (FDA). The discussion centered around the renewal and potential expansion of the company’s Modified Risk Tobacco Products (MRTPs) status for its General Snus products in the United States.

Initially granted MRTP status by the FDA in October 2019, Swedish Match currently communicates to legal-aged consumers that using General Snus in place of cigarettes reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. This message is presently confined to the General Snus website, but the company is seeking to expand its outreach through additional lawful marketing channels, including point-of-sale displays and direct mail to age-verified consumers.

During the half-day meeting, which is part of the FDA’s ongoing review process, Swedish Match presented compelling real-world evidence to the TPSAC, advocating that their claims have effectively contributed to reducing harm among individual tobacco users and benefited public health overall. The evidence aimed to support the renewal of their MRTP status and to broaden the reach of their reduced-risk claims to more effectively transition legal-age smokers away from cigarettes.

The meeting included discussions on a variety of scientific, technical, and consumer communication topics. Swedish Match detailed its responsible marketing practices and showcased research indicating minimal usage of General Snus by unintended populations. The product line includes several varieties like General Snus Original, Mint, Wintergreen, and Nordic Mint, all of which have been available in the U.S. for over a decade.

Gerry Roerty, General Counsel for Swedish Match USA, highlighted the significance of this moment in regulatory history, referencing FDA’s Center for Tobacco Products Director Brian King’s recent remarks on the agency’s new strategic plan aimed at making smoking-related disease and death part of America’s past.

Stacey Kennedy, President of the Americas Region & CEO of PMI’s U.S. business, emphasized the company’s commitment to a cigarette-free America, noting that achieving this goal is more attainable if policies are guided by scientific evidence. Kennedy stressed the importance of continuing dialogue with the FDA to renew the modified risk authorization, which she believes is crucial for clarifying misconceptions surrounding smoke-free products and reducing the prevalence of smoking.

Since acquiring Swedish Match in 2022, PMI has positioned itself as a leader in oral nicotine delivery, with a broad vision that encourages smokers to switch to scientifically substantiated smoke-free products rapidly. PMI has invested over $12.5 billion since 2008 to develop and commercialize such products, aiming to end the sale of cigarettes altogether.

The potential renewal of Swedish Match’s MRTP status could have significant implications for both public health and the tobacco industry, setting a precedent for how reduced-risk products are regulated and marketed in the United States.