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US FDA panel to weigh bid to market nicotine pouches as lower-risk than cigarettes
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US FDA panel to weigh bid to market nicotine pouches as lower-risk than cigarettes
Nov 21, 2025 9:15 AM

Nov 21 (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 ( PM ), 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.

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