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FDA Authorizes Marketing for Nicotine Pouches

Writer's picture: Staff @ LT&CStaff @ LT&C

In a landmark decision, the U.S. Food and Drug Administration (FDA) has authorized the marketing of ZYN nicotine pouches, marking the first time a product of its kind has passed the agency’s stringent Premarket Tobacco Product Application (PMTA) process. Manufactured by Swedish Match, a subsidiary of Philip Morris International (PMI), this approval coincides with significant economic developments, promising job creation and regional growth.


The FDA’s decision underscores the potential public health benefits of ZYN nicotine pouches for adult tobacco users seeking alternatives to traditional tobacco products. “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.

While the FDA acknowledges the reduced harm potential of ZYN products compared to cigarettes and smokeless tobacco, it emphasized that the products are not without risks and are 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 that played a key role in the FDA’s decision.

“While current data show that youth use remains low, the FDA is committed to taking action as appropriate to best protect public health,” said Brian King, director of the FDA’s Center for Tobacco Products.


The FDA’s approval is limited to 10 ZYN products, each available in two nicotine strengths: 3 milligrams and 6 milligrams. The approved flavors include Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen. However, this authorization does not extend to other ZYN products, and PMI is prohibited from making safety or reduced-risk claims without additional FDA review.


PMI and Swedish Match have pledged to implement stringent marketing practices to ensure ZYN products are targeted solely to adults aged 21 and older. The company’s strategy includes avoiding mass-market advertising, using independent age-verification systems for digital promotions, and featuring actors aged 35 or older in advertisements. Additionally, the FDA has mandated demographic tracking of advertisements and ongoing oversight to maintain low youth exposure. The agency retains the authority to suspend or revoke marketing authorizations if public health standards are not met.


“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.

The FDA’s approval comes as PMI undertakes a significant investment to enhance manufacturing capacity to meet growing demand for smoke-free alternatives. PMI’s expansion efforts include creating hundreds of new jobs and enhancing manufacturing capacity to meet growing demand for smoke-free alternatives.


“This investment in U.S. manufacturing capacity will increase the workforce, providing good-paying jobs and helping to meet the increasing demand for smoke-free products,” said Stacey Kennedy, CEO of PMI’s U.S. business.


Regional leaders have praised the economic impact of PMI’s investments, highlighting the job creation and opportunities for families in the area. The expansion is also expected to generate significant construction-related employment, contributing to broader regional development.


According to the FDA, ZYN nicotine pouches pose a significantly lower risk of cancer and other health issues compared to cigarettes and smokeless tobacco products. The agency’s extensive scientific review also found that these products could assist adult tobacco users in transitioning to smoke-free alternatives, aligning with PMI’s broader mission to transition smokers away from combustible tobacco.


Since acquiring Swedish Match in 2022, PMI has invested $12.5 billion globally in the development and commercialization of smoke-free products. The FDA’s authorization is a significant milestone in this journey, offering adult tobacco users a potentially less harmful alternative while maintaining rigorous safeguards to protect public health.

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