Philip Morris Receives FDA Modified Risk Orders for ZYN Products
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 30 2026
0mins
Philip Morris International announced that the U.S. Food and Drug Administration issued Modified Risk Tobacco Product orders for 20 variants of ZYN nicotine pouch products. "These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis'," the company stated. "FDA's decision is an important moment for the more than 45 million legal-age nicotine consumers in America. Today's news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer," she added. "More broadly, it reinforces the agency's science-based approach to evaluating products across the continuum of risk and communicating those findings transparently," said Stacey Kennedy, PMI U.S. CEO.
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Analyst Views on PM
Wall Street analysts forecast PM stock price to rise
11 Analyst Rating
8 Buy
3 Hold
0 Sell
Moderate Buy
Current: 184.760
Low
175.00
Averages
191.95
High
210.00
Current: 184.760
Low
175.00
Averages
191.95
High
210.00
About PM
Philip Morris International Inc. is an international tobacco company. The Company’s product portfolio primarily consists of cigarettes and smoke-free products. Its smoke-free business (SFB) also includes wellness and healthcare products, as well as consumer accessories, such as lighters and matches. The Company’s segments include Europe Region; South and Southeast Asia, Commonwealth of Independent States, Middle East and Africa Region (SSEA, CIS & MEA); East Asia, Australia & PMI Global Travel Retail (EA, AU & PMI GTR), and Americas Region. The Company's brands include Marlboro, HEETS, IQOS, IQOS ILUMA, TEREA, VEEV and ZYN. Its IQOS smoke-free product brand portfolio includes heated tobacco and nicotine-containing vapor products. Its international cigarette brands are Chesterfield, L&M, and Philip Morris. It also owns a number of local cigarette brands, such as Dji Sam Soe and Sampoerna A in Indonesia, and Fortune and Jackpot in the Philippines.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Tobacco Giants Comparison: Altria vs. Philip Morris
- Market Performance Comparison: Altria (MO) trades at $71.83 with a market cap of $121 billion, and despite a slight revenue decline to $20.1 billion in FY 2025, it still reported a net income of $6.95 billion, showcasing its strong profitability in the traditional tobacco market.
- International Strategy: Philip Morris (PM) is priced at $184.05 with a market cap of $284 billion, achieving a revenue growth of approximately 7% to $40.7 billion in FY 2025, alongside a net income of $11.4 billion, indicating robust performance in smoke-free product expansion and international markets.
- Risks and Challenges: Altria faces significant legal risks and competitive pressures, particularly from the gray market of e-cigarettes, with Wall Street estimating only a 5% revenue growth over the next five years, highlighting its sluggish growth in the U.S. market.
- Dividend Yield Comparison: Altria offers a forward dividend yield close to 6%, while Philip Morris exceeds 3.8%, making both stocks attractive options for income-focused investors, despite Altria's growth challenges.
See More
Analysis of Tobacco Giants' Competitive Landscape
- Market Dominance: Altria maintains a stronghold in the U.S. market through its Marlboro brand, generating nearly $20.1 billion in FY 2025 revenue, a slight 1.5% decline, yet net income remains robust at $6.95 billion, showcasing profitability in the traditional cigarette sector.
- Global Expansion Strategy: Philip Morris International aggressively promotes smoke-free products like IQOS and ZYN across 170 markets, achieving approximately 7% revenue growth to nearly $40.7 billion in FY 2025, with net income around $11.4 billion, indicating strong growth potential in international markets.
- Legal Risks and Challenges: Altria faces significant legal exposure from a class-action antitrust lawsuit related to e-cigarette sales, while import bans disrupt its e-vapor strategy, creating uncertainty for future revenues.
- Dividend Yield Comparison: Altria offers a forward dividend yield close to 6%, while Philip Morris exceeds 3.8%, making both stocks attractive for income-focused investors, despite Altria's slower growth trajectory.
See More
Altria Group: A Stable Income Investment Choice
- High Dividend Yield: Altria currently boasts a forward dividend yield of 5.9% and has raised its quarterly dividend for 57 consecutive years, making it one of the so-called 'Dividend Kings', which underscores its appeal and stability for long-term investors.
- Low Volatility Feature: With a five-year monthly beta of 0.50, Altria's stock exhibits only half the volatility of the S&P 500 index, making it an ideal choice for low-risk investors during market fluctuations.
- Industry Resilience: Operating in a sector with inelastic demand, Altria's business model allows it to maintain stable revenue streams even during economic downturns, although future earnings and dividend growth heavily depend on the success of its pivot to non-combustible tobacco products.
- Portfolio Anchoring: While Altria is a top choice for low-volatility investors, it is advisable for investors to include other stocks with strong defensive and dividend growth records in their portfolios to ensure steady income even during market downturns.
See More
Altria Group: A Steady Income Blue Chip Stock
- High Dividend Yield: Altria Group currently boasts a forward dividend yield of 5.9%, having raised its quarterly dividend for 57 consecutive years, demonstrating its stability and appeal as a long-term investment.
- Low Volatility Feature: With a five-year monthly beta of 0.50, Altria's stock price volatility is only half that of the S&P 500 index, making it an ideal choice for low-volatility investors.
- Industry Resilience: As a leading player in the tobacco industry, Altria exhibits strong performance during economic downturns due to the inelastic demand for its products, allowing it to maintain stable cash flows amidst market fluctuations.
- Diversified Investment Advice: While Altria is a top choice for low-volatility investors, it is recommended that investors also consider other defensive stocks to enhance the stability and income potential of their portfolios.
See More
Philip Morris Receives FDA Authorization for ZYN Sales
- FDA Authorization Milestone: The FDA has issued Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouch variants, enabling PMI to market claims of reduced risks for several diseases, marking a significant achievement in the company's smoke-free innovation leadership.
- Diverse Product Range: The FDA's orders include various ZYN flavors such as Cool Mint and Peppermint, available in 3 mg and 6 mg strengths, enhancing PMI's product portfolio and catering to diverse consumer preferences in the nicotine market.
- Strong Scientific Basis: The FDA's review highlighted that nicotine pouches deliver nicotine without burning tobacco, significantly reducing harmful chemical exposure, with data indicating that many adult smokers switching to ZYN reported no cigarette use in the past 30 days.
- Positive Market Outlook: PMI estimates that by December 31, 2025, over 43 million legal-age consumers will be using its smoke-free products, projected to account for 43% of Q1 2026 net revenues, indicating robust growth potential in the smoke-free product market.
See More
Philip Morris Secures FDA Approval for Zyn Modified Risk Claim
- Regulatory Support: Philip Morris has received FDA approval to market Zyn nicotine pouches with a modified risk claim, indicating a lower risk of tobacco-related diseases compared to cigarettes, which will enhance brand recognition and sales potential for Zyn.
- Product Range: The FDA allows 20 Zyn products to be marketed with a modified risk claim, emphasizing their advantages in reducing risks of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis, further solidifying Zyn's position as a safer alternative.
- Market Outlook: Following the FDA's initial approval for Swedish Match to sell Zyn products in January 2025, this new authorization enables them to be marketed as a safer alternative to cigarettes, likely boosting Zyn's market share in the rapidly growing smokeless product segment.
- Investor Reaction: Despite the positive implications for Zyn's market prospects, Philip Morris's stock fell by 0.85% on the day, ending a five-day winning streak, reflecting market caution regarding the overall outlook for the tobacco industry.
See More
Tobacco Giants Comparison: Altria vs. Philip Morris
- Market Performance Comparison: Altria (MO) trades at $71.83 with a market cap of $121 billion, and despite a slight revenue decline to $20.1 billion in FY 2025, it still reported a net income of $6.95 billion, showcasing its strong profitability in the traditional tobacco market.
- International Strategy: Philip Morris (PM) is priced at $184.05 with a market cap of $284 billion, achieving a revenue growth of approximately 7% to $40.7 billion in FY 2025, alongside a net income of $11.4 billion, indicating robust performance in smoke-free product expansion and international markets.
- Risks and Challenges: Altria faces significant legal risks and competitive pressures, particularly from the gray market of e-cigarettes, with Wall Street estimating only a 5% revenue growth over the next five years, highlighting its sluggish growth in the U.S. market.
- Dividend Yield Comparison: Altria offers a forward dividend yield close to 6%, while Philip Morris exceeds 3.8%, making both stocks attractive options for income-focused investors, despite Altria's growth challenges.
See More
Analysis of Tobacco Giants' Competitive Landscape
- Market Dominance: Altria maintains a stronghold in the U.S. market through its Marlboro brand, generating nearly $20.1 billion in FY 2025 revenue, a slight 1.5% decline, yet net income remains robust at $6.95 billion, showcasing profitability in the traditional cigarette sector.
- Global Expansion Strategy: Philip Morris International aggressively promotes smoke-free products like IQOS and ZYN across 170 markets, achieving approximately 7% revenue growth to nearly $40.7 billion in FY 2025, with net income around $11.4 billion, indicating strong growth potential in international markets.
- Legal Risks and Challenges: Altria faces significant legal exposure from a class-action antitrust lawsuit related to e-cigarette sales, while import bans disrupt its e-vapor strategy, creating uncertainty for future revenues.
- Dividend Yield Comparison: Altria offers a forward dividend yield close to 6%, while Philip Morris exceeds 3.8%, making both stocks attractive for income-focused investors, despite Altria's slower growth trajectory.
See More
Altria Group: A Stable Income Investment Choice
- High Dividend Yield: Altria currently boasts a forward dividend yield of 5.9% and has raised its quarterly dividend for 57 consecutive years, making it one of the so-called 'Dividend Kings', which underscores its appeal and stability for long-term investors.
- Low Volatility Feature: With a five-year monthly beta of 0.50, Altria's stock exhibits only half the volatility of the S&P 500 index, making it an ideal choice for low-risk investors during market fluctuations.
- Industry Resilience: Operating in a sector with inelastic demand, Altria's business model allows it to maintain stable revenue streams even during economic downturns, although future earnings and dividend growth heavily depend on the success of its pivot to non-combustible tobacco products.
- Portfolio Anchoring: While Altria is a top choice for low-volatility investors, it is advisable for investors to include other stocks with strong defensive and dividend growth records in their portfolios to ensure steady income even during market downturns.
See More
Altria Group: A Steady Income Blue Chip Stock
- High Dividend Yield: Altria Group currently boasts a forward dividend yield of 5.9%, having raised its quarterly dividend for 57 consecutive years, demonstrating its stability and appeal as a long-term investment.
- Low Volatility Feature: With a five-year monthly beta of 0.50, Altria's stock price volatility is only half that of the S&P 500 index, making it an ideal choice for low-volatility investors.
- Industry Resilience: As a leading player in the tobacco industry, Altria exhibits strong performance during economic downturns due to the inelastic demand for its products, allowing it to maintain stable cash flows amidst market fluctuations.
- Diversified Investment Advice: While Altria is a top choice for low-volatility investors, it is recommended that investors also consider other defensive stocks to enhance the stability and income potential of their portfolios.
See More
Philip Morris Receives FDA Authorization for ZYN Sales
- FDA Authorization Milestone: The FDA has issued Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouch variants, enabling PMI to market claims of reduced risks for several diseases, marking a significant achievement in the company's smoke-free innovation leadership.
- Diverse Product Range: The FDA's orders include various ZYN flavors such as Cool Mint and Peppermint, available in 3 mg and 6 mg strengths, enhancing PMI's product portfolio and catering to diverse consumer preferences in the nicotine market.
- Strong Scientific Basis: The FDA's review highlighted that nicotine pouches deliver nicotine without burning tobacco, significantly reducing harmful chemical exposure, with data indicating that many adult smokers switching to ZYN reported no cigarette use in the past 30 days.
- Positive Market Outlook: PMI estimates that by December 31, 2025, over 43 million legal-age consumers will be using its smoke-free products, projected to account for 43% of Q1 2026 net revenues, indicating robust growth potential in the smoke-free product market.
See More
Philip Morris Secures FDA Approval for Zyn Modified Risk Claim
- Regulatory Support: Philip Morris has received FDA approval to market Zyn nicotine pouches with a modified risk claim, indicating a lower risk of tobacco-related diseases compared to cigarettes, which will enhance brand recognition and sales potential for Zyn.
- Product Range: The FDA allows 20 Zyn products to be marketed with a modified risk claim, emphasizing their advantages in reducing risks of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis, further solidifying Zyn's position as a safer alternative.
- Market Outlook: Following the FDA's initial approval for Swedish Match to sell Zyn products in January 2025, this new authorization enables them to be marketed as a safer alternative to cigarettes, likely boosting Zyn's market share in the rapidly growing smokeless product segment.
- Investor Reaction: Despite the positive implications for Zyn's market prospects, Philip Morris's stock fell by 0.85% on the day, ending a five-day winning streak, reflecting market caution regarding the overall outlook for the tobacco industry.
See More
