The Food and Drug Administration officially approved Thursday the sale of wildly popular Zyn nicotine pouches as a less harmful alternative to smoking cigarettes.
The FDA announced it will be allowing Zyn to market 20 products after a comprehensive scientific review process, making it the first time the agency has authorized nicotine pouches.
“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, director of the office of science in the FDA’s center for tobacco products.
“In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”
The FDA determined that Zyn products pose a lower risk for cancer and other health conditions than cigarettes and other alternatives tobacco products. The agency also cites a study from Zyn showing that many adult cigarette smokers or users of alternative tobacco products completely switched over to Zyn pouches.
Zyn flavors including wintergreen, coffee, cool mint, cinnamon, peppermint, and spearmint are including in the FDA’s list of allowed products. The company currently dominates the U.S. nicotine pouch industry, and is one of many cigarette alternatives owned by tobacco giant Philip Morris.
Sales of Zyn have skyrocketed over the past few years and the product has become a cultural phenomenon, particularly with young adult men. Zyn became popular with influencers on TikTok and the subject of numerous slang words to describe Zyn usage and the sensation that comes with it.
The surge of interest in Zyns took place after federal regulators cracked down on Juul, a flavored vape product with the appearance of a USB-drive that received significant scrutiny for marketing fruity flavors to teenagers.
Senator Chuck Schumer (D., N.Y.), a strong opponent of Juul, voiced displeasure with Zyn last year and warned parents about its use. Schumer, who was Senate Majority Leader at the time, called Zyns “a pouch full of problems” and cited scientific studies on nicotine’s impact on child brain development.
“Kids know what Zyn is. Their parents don’t,” Schumer said.
In authorizing Zyn, the FDA cautioned that it does not consider the nicotine pouches to be a safe product, because the agency holds that no completely safe nicotine products exist. Moreover, the FDA is imposing restrictions on marketing and advertising to ensure Zyns are not promoted to the youth.
“It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, director of the FDA’s center for tobacco products.
“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 2025 national youth tobacco survey measured that 1.8 percent of American middle and high school students used nicotine pouches, despite the increase in sales. With that being said, the FDA observed that the benefits of nicotine pouches for adult smokers outweigh the risks, including to youth.
At the same time, the FDA proposed a new rule Thursday to reduce the addictiveness of cigarettes and and other tobacco products by limiting nicotine levels. The rule is designed to prevent cigarette smokers and consumers of other tobacco products from becoming addicted to nicotine and exposed to harmful chemicals in the process. Nicotine pouches and e-cigarettes would not be affected if the rule is eventually implemented.