Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris International’s Zyn to help adult smokers cut back or quit cigarettes.
The Food and Drug Administration OK’d 10 Zyn flavors, including coffee, mint and menthol. It’s the first time regulators have authorized sales of nicotine pouches, which are the fastest-growing segment of the U.S. tobacco market.
The pouches have been available for more than a decade as FDA reviewed company data intended to show the products can serve as an alternative to cigarettes and other traditional tobacco products. The decision doesn’t mean that Zyn is safe, just less harmful than older alternatives.
To remain on the market, companies generally must show that their products will reduce disease among adult tobacco users without attracting teens and adolescents.
FDA officials said Thursday that Zyn contains fewer harmful ingredients than cigarettes and various types of chewing tobacco, including snuff, which are linked to cancer and other life-threatening diseases. Company data also showed “a substantial portion of adults” who previously smoked switched completely to Zyn, regulators said. The pouches are sold in two different strengths.
“The data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes or smokeless tobacco products,” said Matthew Farrelly of FDA’s Center for Tobacco Products.
The FDA has previously granted similar authorization to several brands of e-cigarettes, a tobacco-heating device, and snus, a type of pasteurized tobacco that is popular in Scandinavian counties. Unlike snus, Zyn and other nicotine pouches don’t contain tobacco, only nicotine and flavoring.
For decades, tobacco companies have tried to develop alternative products to replace dwindling sales of cigarettes, as smoking levels in the U.S. and worldwide continue to fall. E-cigarettes became popular more than a decade ago, but faced a backlash after they triggered a multiyear spike in underage vaping.
In recent months, antismoking groups have warned that nicotine pouches could follow a similar path, pointing to videos of young people popping Zyn and other pouches that have racked up millions of views on social media platforms. Following Thursday’s announcement, advocates quickly criticized the FDA for permitting sales of flavors like citrus, peppermint and wintergreen.
“The FDA should not be authorizing the sale of any flavored tobacco products given the tobacco industry’s well-documented history of using flavored products to appeal to and addict kids,” said Yolonda Richardson, of the Campaign for Tobacco-Free Kids, in a statement.
The FDA pointed to government survey data showing fewer than 2 percent of American high school and middle school students used nicotine pouches last year.
Supporters of the pouches have noted that Zyn works the same way as nicotine gum, lozenges and other older smoking-cessation products: releasing low levels of nicotine that are absorbed into the gums, reducing cravings.
Debate surrounding Zyn spilled over into politics last year, pitting Democrats and Republicans against each other in another skirmish in the nation’s culture war.
In late January, Democratic Sen. Charles Schumer, of New York, called on regulators to investigate Zyn, citing its appeal to teens. Several House Republicans then warned constituents that “Big Brother” intended to “ban nicotine.” Tucker Carlson and other conservative commentators are among the public figures who have embraced Zyn.
Philip Morris has stated it does not employ online influencers or endorsements to promote Zyn, which is marketed in the U.S. by its Swedish Match unit. The product competes with similar ones from competitors, including Altria’s On pouches.
The Associated Press contributed to this report.