As FDA approves new marketing for nicotine pouches, some doctors sound alarms

The U.S. Food and Drug Administration authorized marketing of four new flavored nicotine pouch products this week, bringing to 30 the number of such products the FDA has recently greenlit after considering the public health impact.

Tuesday’s decision on pouches from the brand “on!” is the latest in a series of steps by the Trump administration aimed at boosting this fast-growing sector of the industry. Last week, the White House TikTok account posted a video showcasing the nicotine pouch brand ZYN that included Joint Chiefs Chairman Dan Caine saying the U.S. military consumes “a lot of nicotine.”

In June, the FDA cleared the way for ZYN to market 20 of its products with the favorable new claim that “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The new labeling, which designates it as a “Modified Risk Tobacco Product,” was the first ever granted to a nicotine pouch brand.

Marketing nicotine pouch flavors like “Rich Berry” and “Cappuccino” raises particular concerns for health advocates because of their potential appeal to kids. 

The pouches create a “profound risk for a nicotine-naive person to get dependent and addicted,” said Dr. Brian King, executive vice president of U.S. programs at the Campaign for Tobacco-Free Kids.  

The brands covered by the FDA’s orders are manufactured by subsidiaries of two of the world’s largest tobacco companies: Philip Morris International, which makes ZYN, and Altria Group, for the “on!” brand.

A U.S. spokesperson for Philip Morris International told CBS News, “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.” 

CBS News also reached out to Altria Group for comment but did not receive a response.  

Nicotine pouches represent the fastest growing segment of the U.S. tobacco market. Between January 2023 and August 2025, monthly sales skyrocketed by 250%, CDC Foundation analysis found. Philip Morris International recently opened a $1.2 billion nicotine pouch manufacturing plant in Aurora, Colorado. 

Health concerns

Critics fear the products could be exposing a new generation to the risks of nicotine addiction and have urged more research. 

“Just because we don’t have evidence at this point doesn’t mean that there’s no harm,” said Dr. Purnima Kumar, chair of the Department of Periodontics, Oral Medicine, and Dental Hygiene at the University of Michigan. 

According to the World Health Organization, 16 countries have banned the sale of nicotine pouches. 

The legal age to buy nicotine pouches in the U.S. is 21 years old, but about 460,000 middle and high school students reported using them last year, according to the latest National Youth Tobacco Survey. That makes pouches the second most commonly used form of tobacco product for young people, behind e-cigarettes. 

Nicotine pouches contain a nicotine powder or salt that’s derived from the tobacco plant, as well as plant fiber, flavoring, and other chemicals. The nicotine salt allows the nicotine to cross the blood-brain barrier more easily, making higher levels of nicotine more palatable, according to King.

Dr. Bonnie Halpern-Felsher, a professor of pediatrics at Stanford University, warns that youth nicotine use can prime the brain toward addictive behavior. 

“You’re changing your brain,” Halpern-Felsher said. 

There are also cardiovascular concerns, according to Dr. Aruni Bhatnagar, director of the American Heart Association’s Tobacco Regulation and Addiction Center at the University of Louisville. He said nicotine causes elevated heart rate and blood pressure, and can constrict blood vessels. As a result, the heart is forced to pump faster and blood circulation is stressed.

“We know that there’s a strong link between [nicotine and] blood pressure and heart disease, and particularly heart attacks,” said Bhatnagar.

The area where the pouch sits, inside the mouth against the gums, has caught the attention of dentists and oral surgeons. 

Kumar said the lining of the mouth responds to physical irritation by thickening and whitening. Beyond the white patches, which disappear when pouch use stops, a lasting concern is gum recession, which is irreversible.

While decades of research have explored the health impacts of tobacco and nicotine, Kumar said the recent rise in popularity of oral nicotine pouches means the science is still catching up. 

“More studies are urgently needed,” she said. 

The U.S. spokesperson for Philip Morris International told CBS News the harm surrounding cigarette smoke is clear, and the company is “proud to responsibly provide less harmful modern nicotine alternatives to America’s 45 million legal-age nicotine consumers.” 

There are more than 7,000 chemicals in cigarette smoke, and more than 70 are linked to cancer. While the company acknowledged nicotine is addictive, it said, “It’s the other harmful chemicals in cigarette smoke that are the primary cause of smoking-related diseases.” 

An FDA spokesperson told CBS News that the government’s “modified risk” authorization for ZYN “does not mean these products are safe or risk-free.” 

Instead, the agency says it determined, “based on a rigorous scientific review,” that there is evidence the product helps smokers quit cigarettes, so it believes the decision is “appropriate for the protection of the public health under the statutory standard.” 

The FDA continues to warn “there is no safe tobacco product, and those who do not use tobacco products should not start.” 

King emphasized that if pouches initiate new users, “it could jeopardize the considerable public health progress we’ve made in addressing tobacco product use over the past several decades.” 

The FDA is requiring the owner of ZYN to “conduct postmarket surveillance and studies,” and its status as a “Modified Risk Tobacco Product” will expire in five years. The FDA wrote, “If at any point the agency determines that, among other things, the continued marketing of the products as MRTPs no longer benefits the health of the population as a whole, such as if there is a significant increase in youth uptake, the agency may withdraw the orders.”