FDA-Zyn Pouches

WASHINGTON — On Thursday, federal health authorities approved Philip Morris International’s Zyn nicotine pouches, deeming them beneficial for adult smokers seeking to reduce or quit cigarettes.

The Food and Drug Administration (FDA) authorized 10 Zyn flavors, including coffee, mint, and menthol. This marks the first FDA authorization of nicotine pouches, the fastest-growing segment of the U.S. tobacco market. These pouches have been available for over a decade while the FDA reviewed data supporting their role as a cigarette alternative.

The authorization doesn’t signify Zyn’s safety, only that it’s considered less harmful than traditional alternatives. To maintain market presence, companies must demonstrate their products reduce illness among adult tobacco users without attracting underage consumers.

FDA officials stated Thursday that Zyn contains fewer harmful ingredients than cigarettes and smokeless tobacco like snuff, which are linked to cancer and other life-threatening diseases. Company data indicated a significant portion of former smokers transitioned entirely to Zyn. The pouches are available in two nicotine strengths.

“The data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes or smokeless tobacco products,” noted Matthew Farrelly of the FDA’s Center for Tobacco Products.

The FDA has previously granted similar authorizations to several heated tobacco brands and snus, a pasteurized tobacco popular in Scandinavia. Unlike snus, Zyn and similar nicotine pouches contain no tobacco, only nicotine and flavorings.

For decades, tobacco companies have sought alternative products to offset declining cigarette sales amid falling smoking rates globally. E-cigarettes gained popularity over a decade ago but faced backlash due to a surge in underage vaping.

Recently, anti-smoking groups voiced concerns that nicotine pouches could follow a similar trajectory, citing social media videos showing youth using Zyn and similar products. However, the FDA cited government survey data indicating less than 2% of U.S. middle and high school students used nicotine pouches last year.

Proponents argue Zyn functions similarly to nicotine gum and lozenges, delivering low levels of nicotine to reduce cravings.

The debate surrounding Zyn extended into politics last year, dividing Democrats and Republicans. In late January, Senator Charles Schumer (D-NY) urged regulators to investigate Zyn due to its appeal to teenagers. Conversely, several House Republicans warned of a potential nicotine ban. Public figures like Tucker Carlson have publicly supported Zyn.

Philip Morris asserts it doesn’t use online influencers or endorsements for Zyn, which is marketed in the U.S. by its Swedish Match unit. It competes with similar products from other tobacco companies, including Altria’s On! pouches.