The U.S. Food and Drug Administration (FDA) authorized the marketing of 20 ZYN nicotine pouches after extensive scientific review, making ZYN the first and only authorized nicotine pouch in the United States.

The FDA’s authorization of all ZYN nicotine pouches currently marketed by Swedish Match in the U.S. is an important step to protect the public health by providing better alternatives to cigarettes and other traditional tobacco products for adults.

Philip Morris International (PMI) acquired Swedish Match back in 2022, expanding its category of oral smokeless products.

In the announcement, FDA noted that the agency had reviewed “evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.” The FDA also reviewed “data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. For example, the 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported currently using nicotine pouches.”

Earlier in 2019, following a comprehensive assessment of PMI’s premarket tobacco product applications, the U.S. FDA confirmed that PMI’s flagship smoke-free product, IQOS, is appropriate for the protection of public health and has authorized it for sale in the U.S. The U.S. FDA published a detailed report describing their assessment and their conclusions including results on aerosol chemistry, toxicology, and unintended use.

The notion of tobacco harm reduction (THR) is well recognized in the developed countries where smokers who do not quit switch to less harmful alternatives – heat-not-burn products, vapes and nicotine pouches. The category called smoke-free products (SFP) is increasingly accepted by governments and public as an effective way of reducing harm from smoking among adults. Within this category heat-not-burn products are gaining ground globally. The reason is clear – they don’t burn tobacco unlike conventional cigarettes, but heat it, producing aerosol rather than smoke. According to various studies, the levels of harmful substances in this aerosol are 90-95% lower than in the cigarette smoke.

Currently, PMI sells SFP in 92 markets and has a share of 75% of all SFPs sold in the world. One of such products, IQOS, was launched in Azerbaijan in June 2024.

The FDA (Food and Drug Administration) is a federal agency of the United States Department of Health and Human Services in charge of the public Health Protection.