FDA Reauthorizes Swedish Match’s General snus as a Modified Risk Tobacco Product

Rhea-AI Summary

The FDA has renewed the modified risk tobacco product (MRTP) authorization for eight General snus products from Swedish Match, a Philip Morris International (PM) affiliate. This renewal allows Swedish Match to market these products as lower-risk alternatives to cigarettes. The authorization was based on 330 scientific studies, including epidemiological research from Sweden, which has one of the world's lowest smoking rates. The products can be marketed with claims that using General snus instead of cigarettes reduces the risk of various tobacco-related diseases. This marks a significant milestone as PMI affiliates have now secured 13 of the 16 MRTP authorizations granted by the FDA.

Positive

• First company to achieve FDA renewal for modified risk marketing claim
• Authorization to market products as lower-risk alternatives, potentially expanding market reach
• Strong scientific backing with 330 studies supporting the application
• PMI affiliates hold 81% (13 of 16) of all FDA MRTP authorizations
• Products already established in US market for over a decade

Negative

• FDA will continue monitoring product marketing and population impact
• to marketing to adults 21+ only
• Authorization requires ongoing compliance and annual reporting

Insights

Medical Research Analyst

The FDA's renewal of modified risk status for General snus products marks a significant milestone in tobacco harm reduction. The authorization, backed by 330 scientific studies and Sweden's successful public health outcomes, validates the product's reduced-risk profile compared to conventional cigarettes. The "Swedish experience" demonstrates tangible benefits, with Sweden reporting one of the world's lowest smoking rates.

The renewal allows marketing claims highlighting reduced risks of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis compared to cigarettes. This comprehensive scientific validation strengthens PMI's position in the smoke-free market, particularly following their $12.5 billion investment in smoke-free products and the strategic acquisition of Swedish Match.

Market Research Analyst

This regulatory win significantly strengthens PMI's market position in the rapidly growing smoke-free segment. The renewal not only validates their harm reduction strategy but also provides a competitive advantage in marketing communications. The authorization for eight General snus varieties enhances PMI's diverse smoke-free portfolio, complementing their IQOS and ZYN brands.

With PMI affiliates securing 13 of 16 total FDA MRTP authorizations, they're establishing clear leadership in the regulated reduced-risk tobacco space. This positions them favorably for future growth in the U.S. market, where regulatory compliance and scientific validation are important differentiators.

• Philip Morris International affiliate, Swedish Match, earned first-ever FDA authorization for a modified risk marketing claim and now is the first to achieve an FDA renewal
• PMI affiliates have secured 13 of the 16 modified risk tobacco product (MRTP) authorizations that the FDA has granted, demonstrating the company’s commitment to a smoke-free future.

STAMFORD, Conn.--(BUSINESS WIRE)-- The U.S. Food and Drug Administration (FDA) authorized a renewal of a risk modification order submitted by Swedish Match USA, Inc. (Swedish Match), an affiliate of Philip Morris International, Inc. (PMI) (NYSE: PM), for eight General snus products. As part of the authorization, the agency granted use of the modified risk claim to reach more adults 21+ who smoke or use traditional tobacco products. The agency concluded that renewing the General snus risk modification order will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.

Initially granted by the FDA in October 2019, the modified risk order permitted Swedish Match to communicate on its website 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.”

For a product to be authorized as a modified risk tobacco product (MRTP), applications must demonstrate that they will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole. Swedish Match’s submission included 330 scientific studies, including numerous epidemiological studies from Sweden. Sweden has one of the world’s lowest smoking rates which in part can be attributed to the availability of alternatives such as snus that are better than conventional cigarettes. The FDA noted the importance of the “Swedish experience” in their decision.

“Swedish Match is on a mission to end smoking for good,” said Tom Hayes, president of Swedish Match North America. “The FDA’s decision is an important step in helping cigarette smokers and other traditional tobacco users make the switch to smoke-free products as a better alternative to continued smoking and in helping to protect public health.”

General snus is a smoke-free oral tobacco product, traditionally produced in Sweden, that is non-fermented and air-cured. The renewed risk modification order applies to the eight General snus varieties, which have been available in the U.S. for over a decade and were previously authorized as MRTPs.

In 2022, a PMI affiliate acquired Swedish Match, a leader in oral nicotine delivery. Since 2008, PMI affiliates have invested more than $12.5 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke.

Note to Editor

• The MRTP marketing orders were issued following a 2009 law that granted FDA regulatory authority over tobacco products, including through oversight of innovative tobacco products.
• FDA noted that it will continue to monitor the marketing of the product and its impact on the population.
• The FDA first authorized General snus products as “appropriate for the protection of the public health” in 2015 through its premarket tobacco product application process.
• Since then, Swedish Match USA, Inc. has submitted eight annual reports, the last four of which were combined with MRTP annual reporting.
• The modified risk products submitted and authorized for renewal include eight General snus varieties that have been 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)

Philip Morris International in the U.S.: Delivering a Smoke-Free Future
PMI’s U.S. affiliates are working to deliver a smoke-free future. Since 2008, PMI affiliates have invested $12.5 billion globally to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke with the goal of transitioning them to better alternatives. In 2022, a PMI affiliate acquired Swedish Match – a leader in oral nicotine delivery – creating a global smoke-free champion led by the IQOS and ZYN brands. The U.S. Food and Drug Administration has authorized versions of IQOS electronically heated tobacco devices and Swedish Match’s General snus as modified risk tobacco products. Renewal applications for these IQOS products are pending before the FDA. For more information, please visit www.pmi.com/us/ and www.pmiscience.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241111062598/en/

Philip Morris International

U.S. Communications

Matt Sheaff

+1 (203) 524-9146

matthew.sheaff@smpmi.com

Source: Philip Morris International, Inc.

FAQ

What products received FDA reauthorization for PM's Swedish Match?

Eight General snus varieties received FDA reauthorization as Modified Risk Tobacco Products, including General snus original, white, mint, wintergreen, mini mint, classic blend, and Nordic mint varieties in both pouch and loose forms.

What health claims can Swedish Match (PM) make about General snus?

Swedish Match can communicate that using General snus instead of cigarettes puts users at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.

How many MRTP authorizations does PM now hold through its affiliates?

PMI affiliates have secured 13 out of the 16 modified risk tobacco product (MRTP) authorizations that the FDA has granted.

What scientific evidence supported PM's Swedish Match MRTP renewal?

The renewal was supported by 330 scientific studies, including numerous epidemiological studies from Sweden, where low smoking rates are partially attributed to snus availability.