The Food and Drug Administration is moving toward approving Philip Morris International’s request to market Zyn nicotine pouches as a less-harmful alternative to cigarettes, according to government documents reviewed at a public FDA meeting Thursday.
The agency is considering whether to allow health claims about Zyn’s reduced risk of mouth cancer, heart disease, lung cancer and stroke. But a panel of independent experts raised pointed questions about whether the company’s research demonstrates that marketing claims would actually persuade smokers to switch, and whether the promotion could inadvertently appeal to teenagers.
“There are very few things that are legally available and worse for you than cigarettes,” said Lisa Postow, a panel member and scientist at the National Heart, Lung and Blood Institute. “It’s a pretty low bar to be safer than cigarettes.”
The decision will balance evidence that Zyn may pose lower health risks than cigarettes against concerns that approving marketing claims could expand nicotine addiction to new users—particularly adolescents already drawn to the product through social media.
Philip Morris International’s bid to market Zyn nicotine pouches as a healthier alternative to cigarettes faces a critical decision point at the FDA, with regulators appearing to embrace the company’s claims while experts worry about gaps in research and youth appeal.
The expert panel that reviewed the proposal on Thursday raised concerns that Philip Morris has not provided evidence showing whether marketing messages actually persuade adult smokers to abandon cigarettes. The company also did not test how teenagers might respond to claims about lower health risks.
“Whether or not the claim is going to accelerate that switching, there is no data here to answer that question,” said Cristine Delnevo of the Rutgers Institute for Nicotine and Tobacco Studies, who led the review panel.
What Zyn is and why the decision matters
Zyn is a small pouch containing powdered nicotine. Users place it between their gum and lip for nicotine absorption. The product comes in flavors including mint, coffee and citrus.
The nicotine pouch category has become the fastest-growing segment of the U.S. tobacco market, where cigarette sales have declined for decades. Zyn dominates the category, generating more than $3.24 billion in sales last year and capturing roughly two-thirds of the U.S. nicotine pouch market, according to Nielsen data analyzed by Goldman Sachs.
The FDA authorized Zyn to remain on the market last January, concluding that the pouches posed lower health risks than cigarettes and other traditional tobacco products. Zyn was the first nicotine pouch to receive such authorization.
Now Philip Morris is seeking the next step: permission to tell consumers that Zyn reduces the risk of mouth cancer, heart disease, lung cancer and stroke. If approved, the company could use this language in advertisements, mailers and online marketing.
The regulatory stance and FDA science
Government documents reviewed at the Thursday meeting suggest FDA regulators are leaning toward granting Philip Morris’s request. FDA scientists told the review panel that the evidence supports the company’s claims about reduced risk.
“The totality of the evidence” backs the statement that Zyn reduces the risk of various smoking-related illnesses, according to FDA presentations at the meeting.
But regulatory approval is not certain. The FDA has no announced deadline for a decision and is not bound to follow the expert panel’s guidance.
Expert concerns: research gaps and underage use
The outside experts highlighted critical limitations in the research supporting Philip Morris’s marketing proposal.
The company conducted no long-term studies tracking Zyn users over time or measuring whether they actually switched from cigarettes. It also did not test how teenagers might react to marketing messages about lower health risks—a gap that concerns anti-tobacco advocates.
Andrew Tardiff of the Campaign for Tobacco-Free Kids pointed to features he said make Zyn appealing to young people: a variety of flavors, the product’s concealability and its discrete use. He also cited a Zyn rewards program that allows customers to accumulate points redeemable for electronics, gift cards and apparel—a marketing structure similar to e-cigarette brands that fueled a teenage vaping boom.
Still, federal survey data shows youth use of nicotine pouches remains relatively low. Among high school students, 2.4 percent reported using nicotine pouches in 2024, according to the National Youth Tobacco Survey. Adult use is even lower: fewer than 1 percent of U.S. adults use the products.
The snus precedent and what it shows
Philip Morris already markets snus, an oral tobacco pouch popular in Scandinavia, where studies have shown lower lung cancer and mouth cancer rates among users compared with smokers. The FDA approved a reduced-risk claim for snus in 2019.
Yet snus has achieved little traction in the U.S. market despite the regulatory approval. Panelists noted that fact, questioning whether marketing claims for Zyn would fare differently.
Philip Morris executives said the messaging could eventually shift consumer behavior. Keagan Lenihan, a Philip Morris vice president, told the panel: “The more you communicate to adult smokers with this type of claim it will hopefully only increase switching to Zyn.”
The broader landscape
Nicotine pouches represent a rare growth opportunity for a tobacco industry struggling with declining cigarette sales. The industry views adult switching from cigarettes to lower-risk nicotine products as a sustainable business model.
Public health advocates see the decision differently. They worry that expanded marketing could increase the overall population of nicotine-dependent users, particularly young people who might never have developed nicotine addiction without such promotion.
The FDA will weigh those competing considerations as it decides whether to allow Philip Morris to market Zyn’s relative health benefits to adult smokers.