FDA expands nicotine pouch marketing as doctors warn of youth risks

The Food and Drug Administration has authorized new marketing for more nicotine pouch products, expanding federal clearance for a fast-growing tobacco category even as doctors and public health researchers warn the products could addict young people who have never used nicotine.

The FDA this week authorized marketing of four new flavored nicotine pouch products from the brand on!, bringing to 30 the number of such products the agency has recently cleared after reviewing their public health impact, CBS News reported. The decision follows the FDA’s June authorization allowing ZYN, one of the most popular pouch brands, to advertise that “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

That designation, known as a Modified Risk Tobacco Product authorization, was the first granted to a nicotine pouch brand. An FDA spokesperson told CBS News it “does not mean these products are safe or risk-free.” The agency said it determined, “based on a rigorous scientific review,” that evidence shows the product helps smokers quit cigarettes and that the authorization is “appropriate for the protection of the public health under the statutory standard.”

Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said in a press release quoted by NPR that the decision “is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices.”

Nicotine pouches are small packets placed between the lip and gum. They contain nicotine powder or salt derived from the tobacco plant, along with plant fiber, flavoring and other chemicals. NPR described ZYN as a paperclip-size pouch filled with bleach-white fibers and nicotine crystals that releases nicotine and other chemicals into the bloodstream. The products are sold in flavors such as “Cool Mint,” “Smooth,” “Chill,” “Rich Berry” and “Cappuccino.”

Supporters say pouches can reduce harm for adults who smoke. Mitch Zeller, a Dartmouth Geisel School of Medicine professor and former director of the FDA’s Center for Tobacco Products, told NPR the pouches are “demonstrably less harmful than burning tobacco leaves and inhaling the 7,000 chemicals that are in tobacco smoke.” For heavy smokers who want to quit, he said, switching to nicotine pouches is a “no-brainer.”

Philip Morris International, which makes ZYN, said the product is meant for adult nicotine users. “ZYN is intended as a better alternative for current legal-age nicotine consumers who would otherwise continue to smoke—the most harmful form of consuming nicotine—or use other traditional tobacco products,” a U.S. spokesperson told CBS News. The company acknowledged nicotine is addictive but said, “It’s the other harmful chemicals in cigarette smoke that are the primary cause of smoking-related diseases.”

Public health researchers say the same products may pose risks if they attract new users. “The risks may outweigh the benefits if kids start to use this product,” Zeller told NPR. “That’s not harm reduction. That’s only increasing harm, regardless of how small the risk of a pouch is compared to a cigarette.”

About 460,000 middle and high school students reported using nicotine pouches last year, according to the latest National Youth Tobacco Survey cited by CBS News, making them the second most commonly used tobacco product among young people after e-cigarettes. NPR reported that lifetime use among 12th-graders rose from 6.8% in 2024 to 10.0% in 2025, according to the University of Michigan’s Monitoring the Future study; 4.4% of 12th-graders reported using nicotine pouches in the past 30 days.

Doctors also point to possible cardiovascular, neurological and dental harms. Dr. Bonnie Halpern-Felsher, a Stanford pediatrics professor, told CBS News youth nicotine use can prime the brain toward addiction. “You’re changing your brain,” she said. She told NPR the products may have “meaningful harm reduction potential” for current smokers but said their broader health effects are not yet fully known.

Dr. Aruni Bhatnagar of the American Heart Association’s Tobacco Regulation and Addiction Center said nicotine can raise heart rate and blood pressure and constrict blood vessels. “We know that there’s a strong link between [nicotine and] blood pressure and heart disease, and particularly heart attacks,” he told CBS News.

The FDA is requiring ZYN’s owner to conduct postmarket surveillance and studies. The modified-risk authorization expires in five years, and the agency said it may withdraw the orders if continued marketing no longer benefits the population as a whole, including if youth uptake rises significantly.