Since the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, the Food and Drug Administration (FDA) has conducted extensive scientific reviews of all new products that contain nicotine to determine how their introduction to the American market would affect public health.  More than four years after Scandinavian tobacco company Swedish Match submitted a premarket tobacco product application (PMTA) for approval in March 2020, the FDA approved its nicotine pouch products for sale to American consumers on January 16, 2025. 

The FDA granted these approvals after determining that the authorized ZYN pouches contain substantially lower levels of harmful ingredients compared to cigarettes and smokeless tobacco products, like snuff, and therefore pose a lower risk of cancer and other serious health conditions than alternatives on the market.  The FDA also recognized that the weight of academic evidence indicates that these products have helped many adult users switch away from cigarettes and other tobacco products without significantly increasing youth adoption.  

According to the FDA, the PMTA process requires it to weigh the “risks and benefits to the population as a whole, including … whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available, [and] whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available.”  The FDA has denied 74.5 percent of PMTA applications since 2019, as most products fail to meet these high standards.  Dr. Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, stated, “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.  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.” 

A 2023 study published in the journal Tobacco Prevention and Cessation found that among a sampling of young adults with a median age of 27, the most commonly cited motive for adopting nicotine pouches was to quit smoking.  Offering adult consumers safer alternatives to traditional tobacco products will also likely help reduce the substantial public and private healthcare costs related to smoking-related diseases.  While the FDA acknowledged these potential benefits for adult users, it also emphasized the importance of preventing youth access to these products.  Data from the 2024 National Youth Tobacco Survey indicated that 1.8 percent of U.S. middle and high school students reported current use of nicotine pouches, suggesting that youth usage remains low.  The FDA plans to closely monitor the company's compliance with marketing restrictions aimed at minimizing youth exposure.

The FDA’s scientific review of these products demonstrates how clear and predictable regulatory pathways can encourage the development of innovations that improve public health.  While the PMTA process may aspire to that goal, it does not always work as intended, as multiyear approval delays can weigh heavily on the health of millions of Americans trying to quit smoking.