Philip Morris International Inc. (NYSE:PM) shares were trading slightly higher Friday after the company urged a key U.S. regulator to back a modified-risk label for its ZYN nicotine pouches.
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Philip Morris International said its experts presented scientific findings to the FDA’s Tobacco Products Scientific Advisory Committee as part of a modified-risk tobacco product bid.
The MRTP tag would let its U.S. business tell adult smokers that switching fully to ZYN lowers disease risks tied to smoking.
FDA Advisory Meeting
Philip Morris said the full-day Jan. 22 meeting was part of the FDA’s scientific review of an MRTP application filed by affiliate Swedish Match USA Inc.
The presentation centered on a proposed claim that switching to ZYN reduces risks of six major smoking-linked conditions.
Those conditions include mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
FDA materials stated, “The evidence suggests the proposed modified risk claim is scientifically accurate.”
FDA also noted that youth nicotine pouch use remains relatively low.
The committee also heard that seeing the claim increased awareness that switching from cigarettes to ZYN may reduce disease risk.
Scientific Evidence and Consumer Insight
Philip Morris said data showed consumers understood ZYN is lower risk than cigarettes, but not risk-free.
The advisory panel reviewed evidence showing ZYN contains far lower levels of harmful chemicals than cigarettes.
Panelists also heard that ZYN encourages complete switching from combustible products while limiting unintended use.
The committee also discussed Swedish snus, which received an MRTP designation in 2019 and is linked to low smoking rates in Sweden.
Regulatory Context
In January 2025, the FDA authorized ZYN nicotine pouches for sale through the PMTA pathway.
If the FDA grants MRTP status, Philip Morris could communicate reduced-risk messaging to adult smokers who switch completely.
PM Price Action: Philip Morris shares are trading higher by 1.09% to $171.91 at publication on Friday.
Photo: Jonathan Weiss for Shutterstock
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