FDA will allow Zyn nicotine pouches to stay on the market
Zyn products will be allowed to stay on the market after federal health officials Thursday said the popular nicotine pouches can help adult smokers cut back or switch completely.
The Food and Drug Administration (FDA) authorized 10 Zyn flavors in two different nicotine strengths, including cinnamon, coffee, citrus, menthol and peppermint. This is the first time the agency has greenlighted any nicotine pouch.
The FDA said evidence showed a substantial proportion of adults who use cigarettes or smokeless tobacco products completely switched to nicotine pouch products.
Sales of nicotine pouches, and Zyn specifically, have been skyrocketing and even created a shortage. Though the pouches been available for almost a decade, Zyn has only recently become popular due to online “Zynfluencers.”
The FDA's evaluation showed that Zyn products pose a lower risk of cancer and other serious health conditions than cigarettes and most smokeless tobacco products, such as moist snuff and snus.
The agency said it reviewed data on the risk to young people and found that youth use of nicotine pouches remains low despite growing sales of the pouches in recent years.
For example, a 2024 federal survey showed that only 1.8 percent of U.S. middle and high school students reported using nicotine pouches. However, use among high school students rose to 6 percent last year from 3 percent a year earlier.
“It’s critical that the manufacturer market these products responsibly to prevent youth use,” Brian King, director of the FDA’s Center for Tobacco Products, said in a statement. “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.”
The FDA stressed that while Zyn is now legally allowed to be marketed in the U.S., it does not mean the products are safe.
The products are produced and marketed by Swedish Match, a Stockholm-based tobacco company owned by Philip Morris International.
“The FDA’s decision recognizes the role that ZYN can play in the protection of the public health by helping people switch from cigarettes and other traditional tobacco products,” Tom Hayes, president of Swedish Match North America, said in a statement.
The new authorization comes with restrictions for television, digital and radio advertising to ensure ads are targeted at adults who are 21 and older.
The FDA said the company committed to not using mass-market advertising on radio and TV, and not to use actors or models under 35 years old.