The Food and Drug Administration on Thursday cleared the most popular nicotine pouch in the United States to stay on the market after the product proved to be a safer alternative for adults who smoke cigarettes, saying the benefits outweigh the possible risks to young people.
The agency said Philip Morris International’s Zyn pouches carry a lower risk for cancer and other serious health conditions than traditional dipping tobacco or cigarettes.
The safety data presented to the FDA by the tobacco juggernaut demonstrated that Zyn pouches have substantially lower amounts of harmful contaminants than cigarettes and other smokeless tobacco products.
FDA officials announced Thursday that 20 Zyn nicotine pouch products met the legal standard for approval set by the 2009 Family Smoking Prevention and Tobacco Control Act, which requires the agency to consider the risks and benefits of products to the population as a whole.
“In this case, the data shows that these nicotine products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products,” said Matthew Farrelly, science director for the FDA’s Center for Tobacco Products.
Thursday’s announcement means Philip Morris International can begin digital, television, and radio advertising for Zyn, but advertisements must follow strict rules to avoid appealing to consumers under 21 years of age.
Data collected from the 2024 National Youth Tobacco Survey contributed to the FDA’s decision to green-light Zyn, as only 1.8% of middle and high school students reported currently using nicotine pouches.
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“While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health,” said Brian King, director of the FDA’s tobacco division.
On Wednesday, the FDA officially announced a proposed rule to lower the amount of nicotine in combustible tobacco products by 95%, from about 13 milligrams per cigarette down to 0.07 milligrams. The stated intention of the proposal is to significantly reduce the addictive properties of tobacco products.