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FDA approves 20 nicotine pouch products as Zyn plant goes up in Aurora

Gov. Jared Polis PMI press conference

As a new Zyn manufacturing facility goes up in Aurora — projected to create 500 jobs and produce an annual economic impact of $550 million for the area — the U.S. Food and Drug Administration announced Thursday that it authorized the marketing of 20 Zyn nicotine pouch products following an “extensive scientific review.”

The facility in Aurora is part of Philip Morris International’s big bet on Zyn, an oral pouch that contains nicotine powder and flavorings, such as mint, coffee and citrus. The pouches are the fastest-growing segment of the tobacco industry, which has struggled for decades to replace falling cigarette sales.

PMI announced the new manufacturing facility back in July, with company officials touting the facility as creating jobs and benefitting the economy, as well as promoting a “smoke-free future,” adding it will meet a “growing global demand” for such products. PMI said it was drawn by the area’s workforce and wants support for permitting and expedited construction.

Thursday’s announcement from the FDA marks the first time the agency has authorized nicotine pouch products, according to their website, and the approval was made after the FDA determined that the 20 authorized products met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. 

The products approved are Zyn Chill, Zyn Cinnamon, Zyn Citrus, Zyn Coffee, Zyn Cool Mint, Zyn Menthol, Zyn Peppermint, Zyn Smooth, Zyn Spearmint and Zyn Wintergreen, each of which are approved in two nicotine strengths: 3 and 6 milligram. 

The authorized products have “substantially lower” amounts of harmful constituents than cigarettes and most smokeless tobacco products, the FDA report said. Thus, they pose a lower risk of cancer and other serious health conditions.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Matthew Farrelly, the director of the Office of Science in the FDA’s Center for Tobacco Products, said. “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.”

Federal regulators and experts have long warned that no tobacco product — including nicotine pouches or gels — is safe, and nicotine is highly addictive. The Federal Drug Administration has also acknowledged that the health risks for different products “exist on a spectrum.”

State and local officials lauded the company’s decision to pick Aurora.

PMI plans to begin preliminary operations by the end of this year, with regular production starting in 2026, according a press release from the company. Officials confirmed that the new plant will be located on 150 acres in the northeast quadrant of the future 48th Avenue and Harvest Road intersection.

The FDA will “closely monitor” the marketing and use of Zyn products, they said in their report. 


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