In a groundbreaking move for the industry, the FDA has authorized the marketing of ZYN nicotine pouches — the first product of its kind to pass the agency’s rigorous Premarket Tobacco Product Application (PMTA) process. Produced locally in Owensboro by Philip Morris International’s Swedish Match affiliate, the approval comes as the company undertakes a $232 million expansion, set to add 450 new jobs and boost regional economic growth.
According to the FDA, the approval followed an extensive scientific review, with findings showing that ZYN products pose a significantly lower risk of cancer and other health issues compared to cigarettes and smokeless tobacco products. Additionally, the agency determined that ZYN products may help adult tobacco users transition from traditional tobacco to these smoke-free alternatives.
“These nicotine pouch products meet the bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products,” said Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products.
In its release, the FDA emphasized that the products, while less harmful, are not risk-free and remain unsuitable for non-tobacco users, particularly youth. Data from the 2024 National Youth Tobacco Survey showed that only 1.8% of middle and high school students reported using nicotine pouches, a factor the FDA considered in its decision.
Brian King, director of the FDA’s Center for Tobacco Products, said the agency will monitor the marketing and use of these products closely.
“While current data show that youth use remains low, the FDA is committed to taking action as appropriate to best protect public health,” King said.
The products for which the FDA issued marketing granted orders are the following, each with two nicotine strengths (3 milligram and 6 milligram): ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen.
The authorization is limited to these products and does not apply to others in the ZYN lineup. Additionally, the approval does not allow PMI to claim these products are safer or carry reduced risk without additional review and approval.
PMI and Swedish Match have outlined strict marketing practices to ensure ZYN products are targeted only to adults aged 21 and older. According to PMI, the company will avoid mass-market advertising, use independent age-verification systems for digital ads, and feature actors aged 35 or older in promotional content.
The FDA confirmed that marketing restrictions for the products will include requirements for demographic tracking of audiences reached by advertisements and ongoing oversight to ensure youth exposure remains low. The agency also has the authority to suspend or withdraw marketing authorizations if products no longer meet public health standards.
PMI, which acquired Swedish Match in 2022, says it’s focused on transitioning adult tobacco users to smoke-free products. According to a release, the company has invested $12.5 billion globally in the development and commercialization of smoke-free alternatives. The Owensboro facility has been the primary manufacturer of ZYN since its conception.
“This decision recognizes the role that ZYN can play in protecting public health by helping people switch from cigarettes and other traditional tobacco products,” said Tom Hayes, president of Swedish Match North America.
In August 2024, PMI announced a $232 million investment to expand its Swedish Match facility in Owensboro, which will increase its workforce by 40%. Company leadership said the expansion will enable the plant to operate 24/7 and produce up to 900 million cans of ZYN annually by 2025.
“This investment in U.S. manufacturing capacity will increase the Kentucky plant’s workforce, providing good-paying jobs and helping to meet the increasing demand for smoke-free products,” Stacey Kennedy, CEO of PMI’s U.S. business, said in a statement.
Kentucky Gov. Andy Beshear praised the expansion in a previous release, calling Swedish Match an important partner and job creator. Beshear added that the expansion “creates incredible new opportunities for families in Owensboro and the surrounding region.”
The ongoing construction is expected to create 2,800 jobs during the expansion phase, with an estimated $277 million in annual regional economic impact, according to PMI.
