Smokeless nicotine products – not abstinence – are driving Sweden’s dramatic drop in smoking, according to a leading clinical psychologist.
“Smokeless nicotine is at the heart of Sweden’s smoking decline,” said Karl Fagerström, a prominent researcher who spent his career developing smoking cessation therapies.
Fagerström is best known for founding Niconovum in 2000, the company that created the world’s first tobacco-free nicotine pouches. It uses pharmaceutical grade nicotine, the same kind found in patches and gum. The rationale was to create a better way to stop smoking.
Although pouches began as cessation aids, they’ve since gone mainstream, particularly after major tobacco firms entered the market. Reynolds American acquired Niconovum before British American Tobacco took over in 2017.
Fagerström said public health enthusiasm for smokeless products cooled as the tobacco industry embraced them. This is particularly true in the U.S., one of the few countries where both snus and pouches are legal.
“The difficulty to accept harm reduction here is also because of the tobacco industry,” Fagerström said, in an interview with U.S. newspaper Roll Call. “But when the tobacco industry started to buy up one and each of these small companies, the sentiment changed.”
‘A safer avenue for nicotine consumption’
Fagerström argues that quitting smoking shouldn’t be viewed as an all-or-nothing choice, and points to unsuccessful alcohol and illicit drug prohibition efforts.
The watershed to accepting harm reduction, he said, is recognising that the world is unlikely to stop using nicotine altogether and that other options provide a safer avenue for nicotine consumption.
It’s a view shared by Swedish Match, now owned by Philip Morris International (PMI). “We consume tobacco and nicotine to the same extent [as] any other population. The difference is that we do not die from it to the same extent,” said Patrik Hildingsson, vice president of communications and public affairs.
Sweden restricts smoking in most public places, and cultural norms have shifted. But some public health advocates remain wary of harm reduction. This is largely due to the tobacco industry’s record of misleading the public on the harms of smoking.
“The problem in Sweden is that although we’ve been very successful in making less people smoke because of getting the information out… the tobacco industry in Sweden realised that they had a hard time winning the game about smoking,” said Niclas Malmberg, board member of the think tank Tobaksfakta and a former member of Sweden’s parliament.
A promising trend towards harm reduction
There is far more research on snus than on newer pouches, but early findings suggest a promising trend toward harm reduction. Sweden’s public health agency has acknowledged the important role of snus in reducing the country’s smoking rates.
Fagerström isn’t alone in calling for a shift in approach in the U.S. and other countries to take a similar approach.
In a 2024 editorial for the journal JAMA, former FDA commissioners Scott Gottlieb and Mark McClellan wrote:
“For these currently nicotine-addicted adult smokers, the opportunity to convert to noncombustible products offering nicotine delivery without the combustion-related health risks should be a renewed part of the U.S. public health agenda.”
But bringing harm-reduction products to the U.S. remains a challenge. With costs topping $1.5 million (€1.28) per product for FDA approval, small players are often locked out.
“The U.S. is the most closed market in the world, except if you don’t count the ones where it’s banned outright,” said Daniel Wiberg, who runs a business with his son selling nicotine pouches that shield users’ gums.
Larger companies are also pushing for reform. At a recent Capitol Hill briefing, Matt Holman, former FDA Office of Science director and now a top executive at PMI, suggested Congress could streamline reviews by requiring comparisons to existing products. He also called for performance benchmarks to speed up FDA decisions.
Last month, the FDA opened a public comment period on PMI’s Modified Risk applications for Zyn pouches, but nicotine products still can’t be marketed as safer without official approval.
The FDA’s sluggish pace has drawn criticism from lawmakers, with then-Subcommittee Chair Brett Guthrie calling out the agency’s “failure to authorise tobacco harm reduction products.”
