WASHINGTON – Federal regulators are expanding the market for nicotine pouches, even as health officials voice concerns.
The U.S. Food and Drug Administration this month authorized the marketing of four new flavored nicotine pouch products, bringing the total number of recently approved products in the category to 30. The latest approvals include “on!” brand pouches in flavors Rich Berry, Cappuccino and Autumn Spice.
The move follows a June decision allowing ZYN to market 20 of its nicotine pouch products with a “modified risk” designation, the first of its kind for the category. The label permits the company to state that switching completely from cigarettes to ZYN may reduce the risk of several serious diseases, including cancer, heart disease and lung conditions.
FDA officials say the decisions are aimed at helping adult smokers transition away from more harmful products.
“Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products.
The agency said its review found the pouches contain lower levels of harmful chemicals than traditional cigarettes and many smokeless tobacco products.
But public health advocates argue the approvals are dangerous.
“The FDA’s decision is deeply troubling given the extensive scientific evidence that flavored tobacco products appeal to kids and the fact that nicotine pouches were the only category of tobacco product that saw an increase in youth use last year,” said Campaign for Tobacco-Free Kids President and CEO Yolonda Richardson.
According to the 2025 Monitoring the Future study, the percentage of high school seniors who reported using nicotine pouches in the past 30 days rose from 1.4% in 2023 to 4.4% in 2025. Lifetime use among 12th graders also increased from 6.8% to 10% over the past year.
Health experts warn nicotine exposure during adolescence can have lasting effects.
“You’re changing your brain,” Dr. Bonnie Halpern-Felsher told CBS News. The Stanford University pediatrics professor noted that youth nicotine use increases the risk of addiction.
Other researchers point to cardiovascular concerns, including increased heart rate, higher blood pressure and added strain on the heart.
Despite the concerns, nicotine pouches have become the fastest-growing segment of the U.S. tobacco market. A CDC Foundation analysis found monthly sales rose by roughly 250% between January 2023 and August 2025.
Manufacturers maintain the products are intended for adult smokers seeking alternatives. A spokesperson for Philip Morris International told CBS News that ZYN is designed for “legal-age nicotine consumers who would otherwise continue to smoke.”
