FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.

Rhea-AI Summary

Philip Morris International (NYSE: PM) announced that the FDA has authorized all ZYN nicotine pouch products, making ZYN the first and only authorized nicotine pouch in the United States. The authorization covers 20 different products across 10 flavors (Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill, and Menthol) in both 3mg and 6mg strengths.

The FDA's decision recognizes ZYN's potential role in public health protection by providing alternatives to approximately 45 million Americans who regularly consume nicotine, including 30 million smokers. Swedish Match N.A., a PMI subsidiary, emphasizes responsible marketing practices, including age verification systems and restrictions to adults 21+. The company is also a member of the We Card Program and TruAge® to ensure strict age verification compliance.

Positive

• First FDA-authorized nicotine pouch product in the US market
• Extensive product line authorization covering 20 variants
• Positions PMI strongly in the smoke-free products segment
• Smoke-free business accounts for 38% of PMI's total first-nine months 2024 net revenues
• Product available in 90 markets with 36.5 million adult users globally

Negative

• None.

Insights

FDA Regulatory Expert

The FDA's authorization of ZYN nicotine pouches represents a landmark regulatory milestone in the tobacco alternatives market. This is the first-ever authorization for nicotine pouches, establishing a significant precedent for the entire category. The comprehensive approval of all 20 ZYN variants demonstrates robust scientific evidence supporting their role as reduced-risk alternatives to traditional tobacco products.

The regulatory framework applied here suggests a shifting FDA stance toward novel nicotine delivery systems, particularly those demonstrating lower risk profiles compared to combustible cigarettes. The authorization's scope - covering multiple flavors and nicotine strengths - provides PM with a substantial competitive advantage and significant barriers to entry for competitors.

Market Research Analyst

This authorization significantly strengthens PM's market position in the rapidly growing nicotine pouch segment. ZYN already commands approximately 75% market share in the U.S. nicotine pouch category and this FDA approval creates a substantial moat against competitors. The smoke-free segment now represents 38% of PM's revenues, highlighting the strategic importance of this authorization.

For context, the nicotine pouch market is experiencing explosive growth, with a compound annual growth rate exceeding 50%. This regulatory approval effectively cements ZYN's leadership position and provides PM with a first-mover advantage in a category that's increasingly capturing market share from traditional tobacco products.

Financial Analyst

This regulatory win has profound implications for PM's financial outlook. The authorization de-risks the ZYN portfolio, which has been a major growth driver since the $16 billion Swedish Match acquisition. The smoke-free segment's contribution to revenues is likely to accelerate, potentially improving overall margins given the higher profitability of nicotine pouches compared to traditional cigarettes.

Looking at PM's investment in smoke-free products ($12.5 billion since 2008), this authorization validates their strategic pivot and suggests strong potential for ROI acceleration. The regulatory certainty should also support multiple expansion, as the reduced regulatory risk profile typically commands higher valuations in the tobacco sector.

FDA decision makes ZYN the first authorized nicotine pouch product

Science-based decision affirms that ZYN nicotine pouches are a better alternative for adults who smoke or use other traditional tobacco products

RICHMOND, Va.--(BUSINESS WIRE)-- The U.S. Food and Drug Administration (FDA) today authorized ZYN nicotine pouches making ZYN the first and only authorized nicotine pouch in the United States. The FDA’s authorization of all ZYN nicotine pouches currently marketed by Swedish Match in the U.S. is an important step to protect the public health by providing better alternatives to cigarettes and other traditional tobacco products for adults 21+.

“An estimated 45 million Americans regularly consume nicotine and about 30 million of them smoke, the most harmful form of nicotine consumption,” said Tom Hayes, president of Swedish Match North America, LLC. “The FDA’s decision recognizes the role that ZYN can play in the protection of the public health by helping people switch from cigarettes and other traditional tobacco products.”

The FDA authorized the following products:

• ZYN Cool Mint 3 mg
• ZYN Cool Mint 6 mg
• ZYN Peppermint 3 mg
• ZYN Peppermint 6 mg
• ZYN Spearmint 3 mg
• ZYN Spearmint 6 mg
• ZYN Wintergreen 3 mg
• ZYN Wintergreen 6 mg
• ZYN Citrus 3 mg
• ZYN Citrus 6 mg
• ZYN Coffee 3 mg
• ZYN Coffee 6 mg
• ZYN Cinnamon 3 mg
• ZYN Cinnamon 6 mg
• ZYN Smooth 3 mg
• ZYN Smooth 6 mg
• ZYN Chill 3 mg
• ZYN Chill 6 mg
• ZYN Menthol 3 mg
• ZYN Menthol 6 mg

The FDA’s decision can be found here.

U.S. Marketing Practices Support 21+ Access Only

Swedish Match N.A. LLC is a subsidiary of Philip Morris International Inc. (PMI). PMI’s U.S. affiliates are committed to responsible marketing practices focused on limiting access to adults 21 years of age and older. PMI’s U.S. affiliates do not use social media influencers in the U.S. or people under the age of 35 in marketing materials. They also employ independent age-verification systems like “Double Verify” to direct digital advertising to those over 21, and owned digital platforms are age-gated at the point of access and restricted to current nicotine users of legal age. Swedish Match North America is a Manufacturer Advisory Council member of the We Card Program, a national nonprofit serving retailers of age-restricted products, and a founding board member and investor in TruAge®, a free retail technology that provides stores with a more accurate way of age verification, including the ability to detect fake IDs to ensure 21+ access only.

Philip Morris International: Delivering a Smoke-Free Future

PMI (PMI) (NYSE: PM) 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. Renewal applications for these IQOS products are pending before the FDA. As of June 30, 2024, PMI's smoke-free products were available for sale in 90 markets, and PMI estimates that 36.5 million adults around the world use PMI's smoke-free products. The smoke-free business accounted for approximately 38% of PMI’s total first-nine months 2024 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 aims to enhance life through the delivery of seamless health experiences. References to “PMI”, “we”, “our” and “us” mean Philip Morris International Inc., including its subsidiaries. For more information, please visit www.pmi.com and www.pmiscience.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250116398631/en/

Corey Henry

T. +1 (202) 679 7296

E. Corey.Henry@pmi.com

Source: Philip Morris International

FAQ

What ZYN products did the FDA authorize for PM's Swedish Match subsidiary?

The FDA authorized 20 ZYN nicotine pouch products across 10 flavors (Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill, and Menthol) in both 3mg and 6mg strengths.

How significant is PM's smoke-free business to its total revenue?

The smoke-free business accounts for approximately 38% of PMI's total first-nine months 2024 net revenues.

What age restrictions does PM implement for ZYN products?

PM implements strict 21+ age restrictions, using independent age-verification systems like 'Double Verify' and age-gated platforms, while also participating in the We Card Program and TruAge® verification system.

How many markets is PM's smoke-free product portfolio available in?

As of June 30, 2024, PMI's smoke-free products were available for sale in 90 markets, with an estimated 36.5 million adult users globally.