Swedish Match USA Inc.’s modified risk tobacco product (MRTP) applications for 20 Zyn nicotine pouch products will move on to the substantive review phase.
The Food and Drug Administration (FDA) made the announcement Tuesday and said the application material would be made public on the Center of Tobacco Products’ website after they are redacted. Starting Wednesday, public comments on the application may be submitted on regulations.gov to FDA-2025-N-0835, the agency said.
The FDA authorized these products for sale in January, and the manufacturer is now seeking to market the 20 Zyn nicotine pouch products with a modified risk claim, which requires by law an additional authorization from the FDA.
The FDA said the company is proposing to use the following claim: “Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
“It is a positive development that FDA is progressing the MRTP applications and we hope for an expeditious review,” said Sam Dashiell, regulatory communications for Philip Morris International (PMI) U.S. “Swedish Match has presented the agency with a substantive scientific package that the company believes supports authorizing ZYN as appropriate to promote public health. Providing accurate information on the relative risk of different nicotine products to America’s 45 million legal-age nicotine consumers will help accelerate switching to better alternatives than continued cigarette use—the most harmful form of nicotine consumption.”
FDA’s review will ultimately determine whether the scientific and legal standards are met to market the product as a MRTP, and the agency will issue an order letter either granting or denying the application.
Once all materials for these applications have been made publicly available, the FDA will announce a closing date for the comment period. The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last group of application materials.
“In addition to the public comment, and consistent with requirements of the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) must also be convened to discuss the merits of the application,” the agency said.
Tobacco company Philip Morris International (PMI) bought Zyn maker Swedish Match North America in 2022.
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