FDA Endorses Nicotine Pouches from Philip Morris as a Smoking Alternative
Federal health authorities have recognized the potential public health advantages of nicotine pouches, granting permission for Philip Morris International’s Zyn to be marketed as a tool to aid adult smokers in reducing or quitting smoking.
In a significant move, the Food and Drug Administration (FDA) approved ten flavors of Zyn, such as coffee, mint, and menthol. This marks the first instance where regulators have approved the sale of nicotine pouches, reflecting their rapid growth in the U.S. tobacco market.
Although Zyn pouches have been accessible for over ten years, the FDA’s decision follows a comprehensive review of company-submitted data demonstrating that these products could serve as less harmful alternatives to traditional cigarettes and tobacco products. It’s important to note that the FDA’s approval does not guarantee that Zyn is safe, only that it presents fewer risks compared to older tobacco products.
To justify continued market availability, products must generally prove they will decrease disease rates among adult tobacco consumers without attracting teenagers and young people.
FDA officials highlighted that Zyn contains fewer harmful substances than cigarettes and various types of chewing tobacco, including snuff, which are associated with cancer and other severe diseases. Company research also indicated that a “substantial portion of adults” who previously smoked have completely switched to using Zyn, according to regulators. The pouches are available 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,” stated Matthew Farrelly of the FDA’s Center for Tobacco Products.
The FDA has previously issued similar authorizations to various e-cigarette brands, a tobacco-heating device, and snus, a type of pasteurized tobacco popular in Scandinavian countries. Unlike snus, Zyn and similar nicotine pouches do not contain tobacco, using only nicotine and flavoring instead.
For years, tobacco companies have been striving to develop alternative products to offset declining cigarette sales, as smoking rates in the U.S. and globally continue to decline. E-cigarettes gained popularity over a decade ago but faced backlash following a surge in underage vaping.
Recently, antismoking advocates have raised concerns that nicotine pouches might follow a similar trajectory, citing viral videos of young people using Zyn and other pouches that have garnered millions of views on social media. Following the FDA’s recent announcement, critics were quick to condemn the approval of flavors such as 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 public statement.
The FDA referenced government survey data indicating that fewer than 2% of American high school and middle school students used nicotine pouches in the previous year.
Supporters of nicotine pouches argue that Zyn functions similarly to nicotine gum, lozenges, and other traditional smoking cessation products, delivering low levels of nicotine absorbed through the gums to reduce cravings.
The debate over Zyn reached political arenas last year, creating divisions between Democrats and Republicans as part of the broader cultural conflict in the U.S.
In January, Democratic Senator Charles Schumer from New York urged regulators to investigate Zyn, citing concerns about its appeal to teenagers. In response, several House Republicans warned constituents that “Big Brother” intended to “ban nicotine.” Public figures like Tucker Carlson and other conservative commentators have expressed support for Zyn.
Philip Morris, marketed in the U.S. by its Swedish Match unit, has stated that it does not use online influencers or endorsements to promote Zyn. The product competes with similar offerings from other companies, including Altria’s On pouches.
