The Food and Drug Administration’s recent decision to allow certain nicotine pouches to be marketed as posing fewer health risks than cigarettes could potentially lead to the U.S. becoming smoke-free one day, according to one analyst.
The FDA said Tuesday it will let 20 of Swedish Match USA, Inc.’s ZYN nicotine pouch products be marketed to U.S. consumers with the risk modification 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,” according to the agency’s news release.
“FDA’s review of modified risk products 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,” Acting Director of the FDA’s Center for Tobacco Products Bret Koplow said in a statement. “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.”
The FDA’s decision marks “an acknowledgement of reality,” according to Consumer Choice Center Policy Director David Clement.
“It’s an acknowledgment that, obviously, these products are exponentially less risky than spoken cigarettes, and it’s important that smokers trying to quit know that when they buy them,” Clement told the Daily Caller News Foundation. “And so this is a very positive step forward in terms of overall harm reduction, and it’s a big step forward for anyone who cares about accuracy in marketing.”
The FDA has currently authorized 26 nicotine pouch products in total, according to the agency’s news release from Tuesday.
Clement also suggested that adults having increased access to nicotine pouches could potentially result in the U.S. becoming a “smoke-free” nation in the future.
“I think that as time goes on, and as adults continue to have access to nicotine pouches, and especially nicotine pouches with flavors, the U.S. will be well on its way to be declared a smoke-free country,” Clement explained. “And what I mean by smoking is the under 5% threshold. Which, I believe … [has only been accomplished in] Sweden.”
When reached for comment, the FDA referred the DCNF to its statement from Tuesday.
In 2025, Sweden achieved its goal of becoming smoke-free, with less than 5% of the country’s total population smoking cigarettes on a daily basis, Medical Xpress reported in May.
Using Zyn pouches have become widely adopted by many figures in President Donald Trump’s administration, including Health and Human Services Secretary Robert F. Kennedy Jr., The Wall Street Journal reported in May.
A July 2024 study from the Keck School of Medicine of USC and the University of Nebraska Medical Center suggests that just 2.9% of U.S. adults had ever used nicotine pouches, with 0.4% reporting that they currently use them. Most respondents presently using nicotine pouches also currently smoke cigarettes, per the report.
Worldwide retail sales of nicotine pouches climbed to 23.4 billion units total in 2024, marking an increase of over 50% from 2023, WIRED Middle East reported on Wednesday, citing World Health Organization data.
Some experts have warned of potential cardiovascular risks from using nicotine pouches. While many nicotine pouch products are marketed as being “intended for individuals aged 21+ to help them quit using traditional tobacco products,” recent research suggests that the biggest jump in using nicotine pouches has been among young individuals, according to the American Lung Association.
(DCNF)
