The Food and Drug Administration (FDA) announced on Thursday that it authorized the marketing of Zyn nicotine pouches but will be "closely monitoring youth use."
Newsweek reached out to Zyn for comment.
Zyn is a pouch containing nicotine powder that is intended to rest in a user's mouth while the stimulant is absorbed into their bloodstream. The FDA's authorization of Zyn marks the first time regulators have authorized sales of nicotine pouches.
Nicotine pouches are the fastest-growing segment of the United States tobacco market. They are viewed as a safer alternative than smoking tobacco products, but they are not risk-free and may cause mouth diseases, nicotine addiction and cardiovascular health concerns, according to the Harvard T.H. Chan School of Public Health.
The FDA backed the public health benefits of the nicotine pouches that are meant to help adult smokers cut back or quit cigarettes. The administration OKed 10 Zyn flavors, including coffee, mint and menthol.
The authorization comes after a premarket tobacco product application and an "extensive" science review. The FDA determined that the specific products met the public health standards required by the 2009 Family Smoking Prevention and Tobacco Control Act.
The agency said that the evaluation showed that with "substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products," Zyn poses a "lower risk of cancer and other serious health conditions."
Zyn also provided the FDA with evidence showing that a "substantial proportion of adults" using cigarettes or smokeless tobacco products "completely switched" to the authorized pouches. The FDA found that the pouches provided potential health benefits to those adults, which is "sufficient to outweigh the risks of the products, including to youth."
The pouches have been available for over a decade. The company, parented by Philip Morris International, announced plans to build a factory in Colorado last summer.
The 2024 National Youth Tobacco Survey showed that 1.8 percent of middle school and high school students in the United States currently use nicotine pouches. The Zyn products are meant to be marketed for adults 21 or older.
The FDA warned, however, that the marketing authorization does not mean that the products are safe or "FDA approved."
"There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start," the FDA's press release states.
The FDA also noted that it will continue to "closely monitor the marketing and use of these products," imposing "stringent marketing restrictions" over digital, televised and radio markets to reduce the "potential for youth exposure."
"The company also stated that they intend to implement additional measures to restrict youth access, reduce youth appeal and limit youth exposure to their labeling and advertising, such as: not using mass-market advertising on radio and TV; employing actors/models for marketing that are no younger than 35 years old, or styled to appear under 35; and avoiding any content designed to target youth, including characters, images or themes," the FDA wrote.
Senator Chuck Schumer, a Democrat from New York, held a press conference last year warning against Zyn. He urged the FDA and Federal Trade Commission to examine the product's health effects and marketing. Several Republicans took aim at Schumer's warning at the time.
Dr. Matthew Farrelly, director of the Office of Science in the FDA's Center for Tobacco Products, in a press release: "To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks. In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products."
Dr. Brian King, director of the FDA's Center for Tobacco Products, in a press release: "It's critical that the manufacturer market these products responsibly to prevent youth use. While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health."
Senator Chuck Schumer, at a press conference in June 2024: "It is a pouch packed with problems -- high levels of nicotine. So today, I'm delivering a warning to parents because these nicotine pouches seem to lock their sights on young kids. Teenagers and even lower, and then use the social media to hook them."
With the FDA's announcement, Philip Morris International Inc. shares have risen by 1 percent.