FDA authorizes Zyn nicotine pouches, cites lower risk than cigarettes
The Food and Drug Administration authorized the marketing of 20 Zyn products on Thursday, marking the first such move by the regulator for the fast-growing nicotine pouches segment.
The authorized products pose a lower risk of cancer and other serious health conditions than cigarettes and most smokeless tobacco products, such as moist snuff and snus, due to substantially lower amounts of harmful constituents, the agency said in a statement.
The move comes one day after the FDA unveiled a proposed rule that would make tobacco companies cut nicotine levels to non-addictive levels in cigarettes, most cigars and other combustible tobacco products sold nationwide. The proposed rule excluded nicotine pouches such as Zyn, vaping products, hookahs and premium cigars.
The products are authorized to be sold to people 21 and older, the FDA said in a news release, but the agency did not say they were safe. "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 move has set a "dangerous precedent," said Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, adding that the nicotine pouch products with flavors such as chill, citrus, cool mint and peppermint clearly appeal to kids.
"Rather than taking action to head off further increases and prevent Zyn from becoming the next Juul, the FDA has ignored the warning signs and created serious risk that youth use of nicotine pouch products will continue to increase," Richardson said.
In 2023, e-cigarette maker Juul Labs agreed to pay $462 million over eight years to settle claims by six U.S. states.
The states had accused Juul of falsely marketing its e-cigarettes as less addictive than cigarettes and targeted minors with glamorous advertising campaigns. The company did not admit wrongdoing in the settlement.
Philip Morris PM.N, which bought Zyn-parent Swedish Match in a $16 billion deal in 2022, continues to invest in increasing production for the nicotine pouches amid strong demand.
Zyn, an alternative to traditional chewing tobacco products, is a nicotine pouch that does not contain tobacco.
Nicotine in adolescence can harm the parts of the brain that control attention, learning, mood and impulse control, according to the U.S. Centers for Disease Control and Prevention.