FDA lets Zyn market nicotine pouches as lower-risk than cigarettes
The Food and Drug Administration authorized Zyn to market 20 of its nicotine pouches with modified-risk claims, allowing the brand to tell consumers the products put them at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis than smoking. The orders apply only to those specific pouches and only for the comparison with combustible cigarettes.
Zyn, owned by Swedish Match USA (a Philip Morris International subsidiary), sold 794 million cans in 2025, more than double its 2023 volume. A modified-risk tobacco product order is a high bar: the FDA must find that the claim is supported by evidence and that authorizing it benefits public health overall, weighing smokers who switch against non-users, including teenagers, who might start.
That trade-off is the crux of the criticism. The American Cancer Society Cancer Action Network argued the FDA should be tightening oversight rather than clearing more marketing for an addictive product. The practical effect is that a company can now advertise a nicotine product on health grounds — a message that reduces harm if it moves cigarette smokers over, but raises uptake risk if it reaches people who would otherwise not use nicotine at all. The decision fits a broader loosening of tobacco restrictions under the current administration.