FDA OKs sales of Zyn nicotine pouches, citing health benefits for adult smokers

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WASHINGTON (AP) — Federal health officials on Thursday endorsed the public health benefits of nicotine pouches, allowing Philip Morris International’s Zyn to help adult smokers cut back on or quit cigarettes.

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The Food and Drug Administration has approved 10 flavors of zein, including coffee, mint, and menthol. It’s the first time regulators have allowed a nicotine pouch product to be sold, the fastest-growing segment of the U.S. tobacco market.

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The pouches have been available for more than a decade as the FDA reviewed the company’s data with the goal of showing that the products could serve as an alternative to cigarettes and other traditional tobacco products. The decision does not mean that Zyn is safe, but that it is less harmful than older alternatives.

To gain FDA clearance, companies generally must demonstrate that their products will reduce illness among adult tobacco users without attracting tweens and teens to underage use.

FDA officials said Thursday that zein contains fewer harmful ingredients than cigarettes and various types of chewing tobacco, including snus, which are linked to cancer and other life-threatening diseases. In addition, regulators said company data showed that a “significant portion of adults” who previously smoked had completely switched to Zane.

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

The FDA has previously granted similar authorization to several brands of e-cigarettes, tobacco heating devices, and snus, a type of pasteurized tobacco popular in Scandinavian counties. Unlike snus, Zain and other nicotine pouches do not contain tobacco, only nicotine and flavorings.

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For decades, tobacco companies have tried to develop alternative products to replace dwindling cigarette sales, as smoking levels continue to decline in the United States and globally. E-cigarettes became popular more than a decade ago, but faced backlash after causing a multi-year spike in underage vaping.

In recent months, anti-smoking groups have warned that nicotine pouches could follow a similar path, pointing to videos of young people using Zane and other pouches that have garnered millions of views on social media platforms.

But the FDA pointed to government survey data showing that less than 2% of American high school and middle school students used nicotine pouches in the past year.

Pouch proponents have pointed out that Zane works in the same way as nicotine gum, lozenges and other older smoking cessation products: it releases low levels of nicotine that is absorbed into the gums, reducing cravings.

Zyn is marketed in the United States by Swedish Match, a unit of Philip Morris. It competes with similar products from other tobacco competitors, including Altria’s On Pouches.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Education Media Group and the Robert Wood Johnson Foundation. AP is solely responsible for all content.

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