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.