The U.S. Food and Drug Administration convened a public meeting Thursday to consider whether Philip Morris International can be allowed to advertise its Zyn flavored nicotine pouches as a less-harmful alternative for adults who smoke cigarettes.
The meeting included presentations and materials that, according to the record described by the Associated Press, suggest FDA regulators are leaning toward approving the company’s request. A panel of independent experts asked pointed questions about the research supporting the proposed claims, the risks of underage use, and whether the new marketing language would actually steer smokers away from cigarettes. Still, panelists said the proposed risk statement is likely accurate.
Panel member Lisa Postow, a scientist at the National Heart, Lung and Blood Institute, said: “There are very few things that are legally available and worse for you than cigarettes, so it’s a pretty low bar to be safer than cigarettes.”
FDA is not bound by the panel’s guidance, and the agency will make the final decision on whether to approve the marketing claims, with no deadline given for a decision.
Zyn contains nicotine powder and comes in 10 flavors, including mint, coffee and citrus. The Associated Press described nicotine pouches as a rare source of growth for the tobacco industry as companies have struggled to replace shrinking revenue from cigarettes, chewing tobacco and other legacy products.
Philip Morris International asked FDA to approve new marketing language for Zyn that emphasizes relative health benefits when compared with cigarettes. Specifically, the company sought language stating that using Zyn reduces the risk of “mouth cancer, heart disease, lung cancer, stroke” and other smoking-related diseases, language the company said could be used in promotional materials. If FDA signs off on the reduced-risk claims, the company would be able to use the language in ads, mailing materials and online posts.
Keagan Lenihan, a Philip Morris vice president, said: “Adults who smoke need accurate information about different tobacco products and the relative risks associated with them.” He added in remarks described by the Associated Press: “The more you communicate to adult smokers with this type of claim it will hopefully only increase switching to Zyn.”
FDA scientists at the meeting said “the totality of the evidence” supports the statement that Zyn reduces the risk of various smoking-related illnesses. Outside experts, however, questioned whether Philip Morris conducted long-term studies of Zyn users and whether communications containing lower-risk messaging would lead more smokers to switch away from cigarettes.
Cristine Delnevo of the Rutgers Institute for Nicotine and Tobacco Studies, who led the panel, said: “Whether or not the claim is going to accelerate that switching, there is no data here to answer that question.”
The FDA’s review arrives after the agency authorized Zyn to remain on the market in January, saying company data showed the small pouches are less harmful than cigarettes and other traditional tobacco products. The Associated Press also noted that FDA previously approved a reduced-risk claim for Philip Morris’s snus in 2019, and that panelists pointed to evidence from snus studies conducted in Sweden and other Scandinavian countries, where researchers have reported lower rates of some cancers and related diseases compared with smokers.
The meeting also addressed potential harms to young people and nonsmokers, which FDA is required to review. Anti-tobacco group representatives pointed to signs of youth interest, including videos from “Zynfluencers” and other young people using the pouches that have drawn tens of millions of views on social media.
Andrew Tardiff of the Campaign for Tobacco-Free Kids said Zyn has features that enhance its appeal to young people, including being sold in a variety of flavors, being easy to conceal, and being used discreetly. He also cited concerns about a Zyn rewards program that allows purchasers to accrue points that can be exchanged for electronics, gift cards and apparel.
Despite those concerns, FDA staffers said teenage use of nicotine pouches remains relatively low, at 2.4% of high school students, based on 2024 federal survey data. Overall, the Associated Press reported that less than 1% of U.S. adults use nicotine pouches, even as the products represent the fastest-growing segment of the tobacco market.
Within that category, Zyn is described as the overwhelming U.S. leader. The Associated Press reported that last year Zyn had more than $3.24 billion in sales, representing more than two-thirds of the market, based on Nielsen data analyzed by Goldman Sachs.