FDA weighs marketing flavored nicotine pouches as ‘safer than cigarettes’

The Food and Drug Administration may soon allow tobacco companies to market flavored nicotine pouches placed between the lips and gums as “safer than cigarettes.”

Philip Morris International has asked the federal agency for authorization to advertise that its popular Zyn pouches reduce the risk of “mouth cancer, heart disease, lung cancer, stroke” and other “smoking-related diseases.”

“They are significantly less harmful,” said Guy Bentley of the libertarian Reason Foundation, who testified to support the petition at an FDA advisory hearing last month. “When you burn tobacco, you’re inhaling thousands of toxic chemicals and carcinogens.”

The FDA has set a March 4 deadline to receive public feedback on the application, with a decision expected sometime this year.

Zyn brought in $3.25 billion in sales for Philip Morris last year, dominating a booming market. It comes in flavors such as mint, coffee and cinnamon.

Advocates note that smoking and lung disease rates dropped significantly in Sweden after similar products became widespread there.

But medical experts cite scant evidence that adult smokers switch to the pouches, which have gone viral on social media and appeal primarily to young people.

They warn that online “zynfluencers” hawking the brightly-colored pouches are more likely to increase underage addictions than persuade adults to quit smoking.

“If nicotine pouches cause more people to start using the product, or use more than one tobacco product at once, they would not be less harmful alternatives,” said Thomas Carr of the American Lung Association, which opposes the proposal. “This is especially a concern with flavored nicotine pouches, which are more attractive to youth.”

The association is the nation’s leading lung health advocacy group. It has warned that nicotine damages brain development and makes young users more vulnerable to substance abuse.

Brittney Keller-Hamilton, an epidemiologist with the Center for Tobacco Research at Ohio State University’s Comprehensive Cancer Center, said Philip Morris has shared no evidence of how the new marketing statement would impact teenagers.

“Additionally, [Philip Morris] shared little evidence that the statement would actually increase switching among adult smokers,” said Ms. Keller-Hamilton, whose center produces federally-funded research to guide the FDA’s tobacco industry regulations.

Still, she agreed with an FDA advisory panel that it’s true “at face value” to call the pouches less harmful than smoking.

Some experts insisted the FDA should require Philip Morris to submit financial records proving that its customers switch from cigarettes to pouches.

“If you want to advertise ‘safer than cigarettes,’ prove it in the market by submitting combined U.S. sales volumes for cigarettes and pouches so FDA can measure substitution versus net new uptake,” said Dr. Steven Quay, a physician-researcher at the conservative Hudson Institute.

Trump policies

The FDA authorized Zyn and 19 other pouches for the U.S. market in January 2025, days before President Trump returned to office.

In a July video interview with Brazilian media, Health and Human Services Secretary Robert F. Kennedy Jr. praised the pouches as “probably the safest way to consume nicotine.”

Mr. Trump’s top health adviser said the pouches, which require no spitting because they do not contain tobacco, could save Americans roughly $640 billion a year in cigarette-related health costs.

Mr. Kennedy has moved the Trump administration toward “letting consumers decide for themselves” about health risks, said Jeremy Nighohossian, a health policy expert at the libertarian Competitive Enterprise Institute.

“As long as information provided to consumers is accurate and not misleading, the government should not prevent it from being provided,” Mr. Nighohossian said, referring to “safer than cigarettes.”

Meanwhile, federal regulators have warned that concentrated nicotine powder in Zyn pouches can cause confusion, vomiting, blackouts and death among children.

The FDA estimates that the number of nicotine exposure cases reported to poison centers increased steadily from 2022 to 2025. Of those cases, 72% involved children under 5.

“I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” FDA Commissioner Marty Makary said in September. “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children.”

In a statement emailed to The Washington Times, the FDA’s Center for Tobacco Products touted a pilot program launched last year to “more efficiently review” nicotine pouches as a safer alternative to smoking.

“While cessation is the best outcome, providing a pathway for people who smoke to completely switch to a less harmful regulated product holds significant promise for improved health outcomes, lower health care costs, and longer lifespan,” said Bret Koplow, the center’s acting director.

Eroding trust

The tobacco industry has experienced decades of shrinking revenues from cigars, cigarettes and other products linked to terminal diseases.

Roughly 30 million U.S. adults smoke, mostly concentrated among older adults. While just 1% of Americans use a nicotine pouch, young people have made it the tobacco industry’s fastest-growing product.

A spokesperson for Philip Morris International insisted that advertising nicotine pouches as safer than cigarettes “represents a real opportunity” for customers “switching completely” to Zyn.

“Our Zyn nicotine pouch products have the potential to play a vital role in further reducing the harm and risk of tobacco-related disease,” the spokesperson said in an emailed statement.

Angelica Gianchandani, a New York University marketing instructor, countered that “safer than cigarettes” could spark a consumer backlash if smokers do not embrace the pouches.

“Reputation matters more than image,” Ms. Gianchandani said. “A claim can be technically accurate and still erode trust if it feels designed to reassure rather than inform.”

The FDA promotes four nicotine products as ‘safe and effective’ means to quit smoking: patches, lozenges, gum, oral inhalers and nasal sprays.

Several doctors reached for comment warned that people could interpret “less harmful than cigarettes” as false reassurance that nicotine pouches are harmless.

“They still deliver addictive nicotine and carry health risks with long-term effects, including cardiovascular risks, that are not yet fully understood,” said Dr. Craig Escude, a fellow of the American Academy of Developmental Medicine. “The safest option remains quitting nicotine altogether.”