VAXHOLM, Sweden — The solution is simple, according to Karl Fagerström.

Now retired, the Swedish researcher and inventor has dedicated his life to smoking cessation therapies and strategies. In 2000 he founded Niconovum, a pharmaceutical company that created the first tobacco-free nicotine pouches, sourcing nicotine the same way as for patches or gum.

The rationale? To create a better way to stop smoking.

Niconovum was later sold to Reynolds American Inc., which British American Tobacco then acquired in 2017.

After the European Union embraced e-cigarettes, nicotine pouches became a consumer product sold by tobacco companies.

But the initial interest in such pouches as a cessation aid from public health experts has largely faltered. The tobacco industry, in turn, has embraced the sale of noncombustible products. That’s also been the case in the United States, which is one of the few places where both tobacco-based snus and nicotine pouches are sold.

“The difficulty to accept harm reduction here is also because of the tobacco industry,” Fagerström said in an interview in his home. He pointed to initial interest in e-cigarettes as a cessation tool from anti-tobacco advocates. “But when the tobacco industry started to buy up one and each of these small companies, the sentiment changed.”

Fagerström and others say cessation cannot be viewed as a zero-sum game, pointing to unsuccessful alcohol and illicit drug prohibition efforts.

The watershed to accepting harm reduction, he said, is recognizing that the world is unlikely to stop using nicotine altogether and that other options provide a safer avenue for nicotine consumption.

Patrik Hildingsson, vice president of communications and public affairs at Swedish Match, a subsidiary of Philip Morris International, said that in Sweden, people use the same amount of tobacco and nicotine as in many other countries.

But in other countries, they smoke. In Sweden, smokeless products are preferred.

“We consume tobacco and nicotine to the same extent than any other population. The difference is that we do not die from it to the same extent,” he said.

Smoking is the primary driver of tobacco-related deaths and is highly restricted in most Swedish public places. Still, some on the public health side are skeptical of harm reduction. They argue that the tobacco industry’s history of misleading customers about the public health impact of their products means they can’t be trusted.

As recently as 2006, for example, a U.S. federal judge ruled that the major tobacco companies had misled smokers about the danger to their health in violation of anti-racketeering laws.

“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 realized that they had a hard time winning the game about smoking,” said Niclas Malmberg, who is a board member for the think tank Tobaksfakta and a former member of Sweden’s parliament.

Tobacco harm-reduction advocates say educating individuals about these products could actually be effective at helping people move away from combustible cigarettes compared with more long-standing cessation methods. Even some health experts question the long-term effectiveness of nicotine replacement therapy and nicotine gum.

There’s a breadth of research on the health impact of snus, which has a long cultural tradition in Sweden. It’s more limited for the newer nicotine pouches, and many datasets often lump both products together, especially as a cessation aid.

Sweden’s public health agency, Folkhälsomyndigheten, has published some research showing an association between snus use and smoking but acknowledges more evidence is needed.

The agency itself has called for tobacco prevention efforts to pivot toward nicotine prevention.

“If you compare something that’s very dangerous with something that’s less dangerous, that doesn’t make the thing that’s less dangerous good,” said Malmberg. “Once you get exposed to nicotine, you have to get that nicotine, and it doesn’t really matter where you get it from.”

Harm reduction

Fagerstrom, the founder of Niconovum, isn’t the only one to support tobacco harm reduction.

Two former Food and Drug Administration commissioners, Scott Gottlieb and Mark McClellan, have also signaled their support.

“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 US public health agenda,” they wrote in a joint editorial for JAMA in 2024.

There’s also interest among former smokers who have found solace in alternative products. They include Bengt Wiberg and Daniel Wiberg of Stingfree AB, a father and son who run a business selling nicotine pouches that shield users’ gums.

The elder Wiberg, a longtime smoker, had been a dual cigarette and snus user until he quit smoking in 1991. After he shifted to nicotine pouches and snus, he developed oral sores and receding gums.

Pouches require increasing the pH of a user’s mouth to allow the nicotine to absorb. That process can irritate the mouth. Having the dentist tell him that the snus were giving him mouth problems, he said, “was the worst day in my life.”

“You know, besides my family and children and grandchildren, I simply love snus,” said Bengt.

The ordeal inspired him to attach a makeshift bandage to a pouch to protect his gums. The pain and his dental concerns, he said, stopped.

“If you talk to any Swedish dentist, they will say that they definitely know they have patients who use pouches,” said Daniel. “In a way things are going now, maybe in 10 years, the average U.S. dentist will also know, ah, you’re using pouches.”

The Wibergs acknowledged that gaining FDA authorization can be cost-prohibitive for smaller companies like theirs.

‘The most closed market in the world’

While Sweden’s long history of smokeless product use has lent itself to the need for more flexibility in its regulation, the U.S. industry is in its burgeoning stages of determining how different products can be marketed.

The FDA can authorize tobacco and nicotine products as having modified risk or for premarket approval under a 2009 law. In the United States, they’d need to spend about $1.5 million per stock-keeping unit for scientific research.

Grouping highly similar products together could speed up the process, the Wibergs said.

“The U.S. is the most closed market in the world, except if you don’t count the ones where it’s banned outright,” Daniel said.

It’s a notion also argued by much larger companies.

Matt Holman, PMI’s vice president and chief scientific and regulatory strategy officer, speaking at a recent briefing with Capitol Hill staff, suggested that “Congress could mandate that for any product coming through the pathway, at least today, the comparative product should be implemented.”

Holman, a former director of the Office of Science at the FDA’s Center for Tobacco Products, said the biggest impact Congress could have on this issue would be mandating performance goals for the FDA so that companies would have an answer on authorization in a timely manner. The CTP is funded through tobacco user fees.

Last month, the FDA announced that it’s seeking public comment on PMI’s Modified Risk Tobacco Products applications for the 20 Zyn pouches that the agency authorized in January. Nicotine and tobacco products can’t legally market themselves as having fewer health risks without the FDA granting them this status.

The broader backlog has caught the attention of Congress, which also touts a Tobacco Harm Reduction Caucus. Last year, during an Energy and Commerce Health Subcommittee hearing, then-Subcommittee Chair Brett Guthrie, R-Ky., called out the “FDA’s failure to authorize tobacco harm reduction products.”

Henry Waxman, chairman at Waxman Strategies who was a House Democrat from California from 1975 to 2015, is more critical of the approach. In Congress he shepherded passage of the 2009 law.

“Who would have thought we would embrace the approval of products that do so much harm?” Waxman said during a briefing earlier this year. “Their argument is that you should use these products instead of tobacco because it was less harmful. But all of these products have one thing in common: They are addictive.”

Smokeless resistance

Not everyone is interested in switching to a different product.

On March 10, Jafar Sala smoked by his cab parked outside Danderyd Hospital in the greater Stockholm area, where he has resided for 38 years.

Despite the increasing limitations on smoking in Sweden, he’s never been tempted to switch to snus or nicotine pouches.

He began smoking during his military service and averages a pack of Winstons a day.

“You can see them everywhere, even in town,” Sala said of cigarettes.

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