US FDA panel to weigh bid to market nicotine pouches as lower-risk than cigarettes

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(Reuters) -The U.S. Food and Drug Administration said on Friday that it will convene a panel of experts on January 22, 2026, to review an request by Swedish Match USA, a unit of Philip Morris International, to market its ZYN nicotine pouches as lower-risk alternatives to cigarettes.

The advisory committee will examine modified-risk applications for 20 ZYN products, each sold in 3-mg and 6-mg strengths.

The FDA in January 2025 cleared the same 20 products for sale after reviewing them under its premarket system for new tobacco products, allowing them to remain on the U.S. market.

That decision did not allow Swedish Match to claim the products reduce disease risk.

Swedish Match USA now wants permission to use the statement: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The panel will discuss data on how the products compare with cigarettes in terms of health risks, how consumers might understand and react to the proposed claim, and what effect such marketing could have on overall public health.

Sales of Zyn have surged in recent months, with shipments in the Americas jumping 38% year-over-year in the third quarter of 2025, while sales of traditional cigarettes continue to fall significantly.

The FDA’s review will determine whether the scientific and legal standards are met for marketing ZYN as a modified-risk tobacco product.

It will issue a final order either granting or denying the application after the advisory committee’s deliberations.

(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Tasim Zahid)