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Philip Morris' IQOS Retains FDA Modified-Risk Authorization
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Key Takeaways
FDA reauthorized IQOS as modified-risk, allowing reduced-exposure messaging for adult smokers who switch.
The renewal covers multiple IQOS versions plus HEETS tobacco sticks sold in the United States.
Smoke-free products are growing revenue and profit share after billions invested in the shift.
Philip Morris International Inc. (PMI - Free Report) has received renewed regulatory backing in the United States, as the Food and Drug Administration (“FDA”) reauthorized its IQOS heated tobacco system as a modified risk tobacco product. The decision allows the company to continue communicating that switching completely from cigarettes to IQOS can reduce exposure to harmful chemicals, based on the agency’s scientific assessment.
The renewal covers multiple versions of the IQOS device along with associated tobacco sticks sold under the HEETS brand. The FDA concluded that extending this authorization is appropriate for public health, taking into account both current tobacco users and non-users.
This regulatory decision reinforces PM’s broader strategy to transition away from traditional cigarettes toward smoke-free alternatives. The company has been investing heavily in this shift for more than a decade, committing billions of dollars to research, product development and commercialization. The effort is increasingly reflected in its business mix, with smoke-free products contributing a substantial and growing share of overall revenues and profits.
Image Source: Zacks Investment Research
IQOS remains central to this transformation. The product is already available in dozens of markets worldwide and has shown strong adoption in countries such as Japan, where heated tobacco products have significantly reduced cigarette consumption. Philip Morris continues to position IQOS as a key tool for adult smokers seeking alternatives, alongside other smoke-free offerings like nicotine pouches and e-vapor products.
The FDA’s renewed authorization provides both validation and continuity for PM’s reduced-risk portfolio. As regulatory frameworks evolve and consumer preferences shift, the decision strengthens the Zacks Rank #3 (Hold) company’s ability to advance its long-term goal of replacing cigarettes with scientifically substantiated alternatives for adult smokers.
Shares of PM have risen 3.8% over the past six months, outperforming the industry’s growth of 1.5%.
The Zacks Consensus Estimate for Smithfield Foods’ current financial-year sales and earnings indicates growth of 1.1% and 7.5%, respectively, from the prior-year reported levels. SFD delivered a trailing four-quarter earnings surprise of 15.3%, on average.
Tyson Foods, Inc. (TSN - Free Report) operates as a food company through the Beef, Pork, Chicken and Prepared Foods segments. TSN currently carries a Zacks Rank #2 (Buy).
The Zacks Consensus Estimate for Tyson Foods’ current fiscal-year sales calls for growth of 4.4%, while the consensus mark for earnings indicates a decline of 4.1% from the year-ago figures. TSN delivered a trailing four-quarter earnings surprise of 16.5%, on average.
Mama's Creations, Inc. (MAMA - Free Report) manufactures and markets fresh deli-prepared foods in the United States. At present, MAMA carries a Zacks Rank of 2. Mama's Creations delivered a trailing four-quarter earnings surprise of 125%, on average.
The consensus estimate for Mama's Creations’ current fiscal-year sales and earnings implies growth of 29.8% and 80%, respectively, from the year-ago figures.
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Image: Bigstock
Philip Morris' IQOS Retains FDA Modified-Risk Authorization
Key Takeaways
Philip Morris International Inc. (PMI - Free Report) has received renewed regulatory backing in the United States, as the Food and Drug Administration (“FDA”) reauthorized its IQOS heated tobacco system as a modified risk tobacco product. The decision allows the company to continue communicating that switching completely from cigarettes to IQOS can reduce exposure to harmful chemicals, based on the agency’s scientific assessment.
The renewal covers multiple versions of the IQOS device along with associated tobacco sticks sold under the HEETS brand. The FDA concluded that extending this authorization is appropriate for public health, taking into account both current tobacco users and non-users.
This regulatory decision reinforces PM’s broader strategy to transition away from traditional cigarettes toward smoke-free alternatives. The company has been investing heavily in this shift for more than a decade, committing billions of dollars to research, product development and commercialization. The effort is increasingly reflected in its business mix, with smoke-free products contributing a substantial and growing share of overall revenues and profits.
Image Source: Zacks Investment Research
IQOS remains central to this transformation. The product is already available in dozens of markets worldwide and has shown strong adoption in countries such as Japan, where heated tobacco products have significantly reduced cigarette consumption. Philip Morris continues to position IQOS as a key tool for adult smokers seeking alternatives, alongside other smoke-free offerings like nicotine pouches and e-vapor products.
The FDA’s renewed authorization provides both validation and continuity for PM’s reduced-risk portfolio. As regulatory frameworks evolve and consumer preferences shift, the decision strengthens the Zacks Rank #3 (Hold) company’s ability to advance its long-term goal of replacing cigarettes with scientifically substantiated alternatives for adult smokers.
Shares of PM have risen 3.8% over the past six months, outperforming the industry’s growth of 1.5%.
Stocks to Consider
Smithfield Foods, Inc. (SFD - Free Report) produces various packaged meats and fresh pork products in the United States and internationally. It sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Smithfield Foods’ current financial-year sales and earnings indicates growth of 1.1% and 7.5%, respectively, from the prior-year reported levels. SFD delivered a trailing four-quarter earnings surprise of 15.3%, on average.
Tyson Foods, Inc. (TSN - Free Report) operates as a food company through the Beef, Pork, Chicken and Prepared Foods segments. TSN currently carries a Zacks Rank #2 (Buy).
The Zacks Consensus Estimate for Tyson Foods’ current fiscal-year sales calls for growth of 4.4%, while the consensus mark for earnings indicates a decline of 4.1% from the year-ago figures. TSN delivered a trailing four-quarter earnings surprise of 16.5%, on average.
Mama's Creations, Inc. (MAMA - Free Report) manufactures and markets fresh deli-prepared foods in the United States. At present, MAMA carries a Zacks Rank of 2. Mama's Creations delivered a trailing four-quarter earnings surprise of 125%, on average.
The consensus estimate for Mama's Creations’ current fiscal-year sales and earnings implies growth of 29.8% and 80%, respectively, from the year-ago figures.