The Food and Drug Administration said on Tuesday, June 30, that it will let Philip Morris market its Zyn nicotine pouches as less harmful than cigarettes. The agency cleared 20 versions of the products to bear a specific health claim for adult smokers.
This marks the first time nicotine pouches have received approval for modified risk claims in the United States.
FDA Grants Zyn Reduced-Risk Marketing Authorization
The pouches, made without tobacco leaf but containing nicotine, can now be marketed with the statement that using Zyn instead of cigarettes puts users at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.
The decision covers 10 flavors, each available in two nicotine strengths: 3 milligrams and 6 milligrams.
Flavors include Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen.
Swedish Match, the Stockholm-based company owned by Philip Morris International, produces and sells them in the U.S.
Zyn pouches have been available for legal sale since January 2025, but today’s order adds the ability to make the reduced-risk claims.
Why the FDA Says Zyn Is Less Harmful Than Cigarettes
FDA officials reviewed scientific data on how the products are actually used by consumers and their potential effects on both smokers and non-smokers.
“FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” Bret Koplow, acting director of the agency’s Center for Tobacco Products, said in a statement.
“Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products,” Koplow added.
Philip Morris Scores Major Regulatory Victory
The move represents a major win for Philip Morris as traditional cigarette sales continue to fall in the United States.
Nicotine pouches have grown rapidly in recent years, filling a gap for people seeking smokeless options. Sales data shows sharp increases, with Zyn holding a big share of the market.
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The Trump administration has taken steps to ease some restrictions on nicotine products, regarding them as potential alternatives for adult smokers.
Zyn has picked up noticeable popularity in conservative circles, with former Fox News host Tucker Carlson among those who helped draw attention to the brand before launching his own competing pouch product, Alp.
Use has also appeared among some figures close to the White House.
Health Advocates Warn About Youth Nicotine Use
The Hill reports that health advocates, however, worry the flavored products and new marketing claims could draw in young people who have never smoked.
Data from youth surveys point to Zyn as the top nicotine pouch brand among teens who try these items, with most youth tobacco users choosing flavored versions.
The American Lung Association cited data from the National Youth Tobacco Survey showing that Zyn holds a leading position among pouch users.
Just over 1.7 percent of young respondents reported using pouches, but flavors dominate that group.
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“Nicotine pouches are not approved to help people quit smoking, and these flavored products are already being taken up by youth at increasing rates,” Mike Seilback, an assistant vice president at the American Lung Association, said in a statement.
“It is appalling that the FDA would authorize flavors like citrus, cool mint and cinnamon as modified risk tobacco products, which attract kids,” he wrote.
“The Lung Association calls on the FDA to reverse this action and reject pre-market tobacco applications for flavored tobacco products.”
Seilback added, “We must protect our children from a lifelong addiction to nicotine.”
Public health groups have raised similar points throughout the review process. They argue that even if the products pose lower risks than cigarettes for adult smokers who switch completely, easier marketing could normalize nicotine use and bring in new users, especially teenagers drawn to the small, discreet pouches and appealing tastes.
What the FDA Decision Means for Adult Smokers
FDA officials stated that no tobacco product is safe and warned that young people should not use any nicotine products and that non-users should not start.
They said that the modified risk order does not mean the FDA approves Zyn as a quitting aid or considers it harmless.
Philip Morris and Swedish Match have said the products are meant for adult smokers looking to switch.
