Pouches with higher nicotine levels can make a vital contribution to tobacco harm reduction, by delivering the satisfaction people may need if they’re to avoid returning to deadly cigarettes. But they won’t perform this role if they’re not available.
“People need different doses for different reasons,” Dr. Raymond Niaura, a psychologist and professor of social and behavioral sciences at New York University’s School of Global Public Health, told Filter. “They may metabolize nicotine more quickly, it might be their neurological make-up, maybe they’re more or less sensitive to the effects of nicotine or have developed a tolerance to it.”
A broad range of nicotine pouch strengths, allowing people who smoked to go for higher nicotine levels if needed, is therefore crucial to maximize harm reduction, he said.
A new study, published in the Scientific Reports journal, underlines this point. The researchers set out to understand how much nicotine higher-strength modern pouches delivered to a person’s bloodstream, and how quickly. Most prior studies of this kind had only looked at products with lower nicotine levels.
The study was conducted in Sweden, where mass switching to snus and pouches has dramatically reduced smoking rates.
Twenty-seven adults who already used snus or pouches were randomly assigned to use one of three higher-nicotine pouches, which are currently not available in the United States, or a tobacco snus comparator. The nicotine doses of the pouches used were 14 mg, 16 mg and 20 mg, while for the snus product it was a comparably high 16.6mg.
The products “provide satisfactory levels of nicotine delivery for adult smokers with no intention to quit smoking, and with positive subjective outcomes.”
Participants exclusively used their assigned product over a period of four days spent in a clinic setting. A “single-blind” protocol meant they didn’t know which of the products in question they were using, but the investigators did. Blood samples were taken to assess nicotine concentrations, and the participants answered questions about cravings, satisfaction and other aspects of their experiences.
“Overall, this study has demonstrated that the three zoneX MOND [modern oral nicotine delivery] products tested provide satisfactory levels of nicotine delivery for adult smokers with no intention to quit smoking, reducing urge to use nicotine following use, and with positive subjective outcomes,” the authors concluded.
The researchers are all employees of the tobacco company Imperial Brands, which manufactures the pouches used. Though some would see that as discrediting their findings, the study was peer-reviewed before publication. Moreover, the basic finding that higher nicotine dosage has harm reduction value matches what independent research has shown about other types of safer nicotine products, with many people who smoked heavily saying that higher-nicotine vapes were the only reason they were able to quit.
“Higher nicotine strength products deliver higher levels of nicotine to participants’ bloodstreams,” Matthew Stevenson, one of the co-authors, told Filter. “Our tobacco-free products generally scored more favorably than the snus comparator for satisfaction, psychological reward, aversion and relief.”
Acknowledging that all the products, including snus, “exhibited similar reductions in urge to use nicotine both during, and following usage,” he said that overall, the research “adds to the existing scientific weight of evidence that MOND products offer encouraging THR potential for adult smokers.”
“One size does not fit all,” and someone who smokes heavily is likely to need a higher-strength safer alternative.
Dr. Niaura of NYU, who was not involved in the study, said that it further solidifies the idea of a “dose-response relationship.”
He added that the research reminded him of the history of NRT, because a large part of the history of patches and gums has revolved around the question of dosage. “The same logic applies here,” he said. “One size does not fit all,” and someone who smokes heavily is likely to need a higher-strength safer alternative.
If we accept the importance of higher-nicotine pouches, the next question concerns their availability. And as Stevenson noted, the study findings “pertain to products sold in Europe and are not indicative of any product currently authorized or marketed in the US.”
In January, tobacco harm reduction advocates celebrated when the United States Food and Drugs Administration (FDA) authorized the marketing of certain modern nicotine pouches for the first time.
Another big development came in September, when the FDA—known for its onerous, chaotic and bitterly contentious authorization process for vapes—resolved to “drop a requirement that [pouch] manufacturers submit product-specific studies in several areas,” under a pilot program. By relying instead on available research about nicotine pouches in general, this has the potential to streamline future pouch authorizations.
Yet right now, the 20 Zyn products authorized in the US have nicotine levels no higher than 6 mg.
“The FDA is maybe a bit squeamish about higher doses … It’s a start. It’s not game over.”
“The FDA is maybe a bit squeamish about higher doses, they’re just being cautious,” Niaura said, adding that, “any regulatory agency is going to be conservative.”
“They only recently authorized them,” he continued. “Once everyone has more experience of them in the real world, there will be opportunities to do follow-up studies.”
“It’s a start,” he summarized. “It’s not game over.”
From a Swedish perspective, this looks like unjustified foot-dragging.
“Regulation should reflect [that] higher nicotine content is closer in its delivery to cigarettes and that, for some people, this is what is needed for them to make the switch and avoid relapse,” Suely Castro, founder of the nonprofit Quit Like Sweden, told Filter.
But many authorities in Europe, too, are failing to get the message. Luxembourg, for instance, has drafted a law to restrict dosage to an incredibly low 0.048 mg of nicotine per pouch. Advocates have described it as a de facto pouch ban, and fear it will jeopardize smoking cessation.
Castro said Luxembourg only has to look to Sweden to see how easy access to snus and pouches has resulted in far fewer smoking-related deaths per capita than the rest of Europe. Sweden’s smoking rate is on the verge of dropping below the 5 percent “smoke free” threshold. Luxembourg’s rate is estimated at 21.7 percent.
“Sweden’s model works precisely because it’s not based on prohibition or limiting products’ functionality to the point that it is unsuitable as a quitting aid,” Castro said.
It’s a lesson lawmakers and regulators need to learn fast, if they’re serious about preventing death and disease from smoking.
Photograph (adapted) by Global State of Tobacco Harm Reduction via Flickr/Creative Commons 2.0
Zyn pouches are manufactured by a subsidiary of Philip Morris International (PMI). The Influence Foundation, which operates Filter, has received unrestricted grants from PMI. Filter‘s Editorial Independence Policy applies.
