In a groundbreaking move, the United States Food and Drug Administration (FDA) authorized the marketing of 20 Zyn nicotine pouch products in a range of flavors on January 16. It’s the first time nicotine pouches have been greenlit under the agency’s Premarket Tobacco Product Applications (PMTA) process.
The decision is a win for science and harm reduction, safeguarding cigarette alternatives that the FDA now acknowledges “offer greater benefits to population health than risks.” However, this progress also highlights absurd contradictions in the FDA’s overall approach to nicotine and tobacco.
Pouches like these contain nicotine without the toxic chemicals and carcinogens involved in combustible cigarettes. The FDA’s scientific evaluation found that the products offer significant harm reduction benefits, and that adults who use nicotine pouches are more likely to quit smoking—hugely reducing their exposure to known harms—than those who try to go cold-turkey.
The FDA’s evaluation underscores a key point: The potential benefit to adults who smoke outweighs any risks of youth use.
Moreover, the FDA’s evaluation underscores a key point: While youth use of nicotine pouches remains low—only 1.8 percent of US middle and high school students reported using these products in 2024—the potential benefit to adults who smoke outweighs any risks of youth use.
This is the essence of tobacco harm reduction: a public health strategy that prioritizes transitioning people away from products that kill, rather than worrying excessively about products that don’t.
The FDA’s recent decision reflects a growing recognition of nicotine’s role in harm reduction. Despite its addictive properties, nicotine is not the direct cause of smoking-related illnesses; the culprits are the tar and thousands of chemicals produced when tobacco is burned. By separating nicotine from combustion, products like Zyn provide a pathway to reduce harm, without the obstacle of having to quit nicotine, which many people either can’t or won’t do.
While the FDA’s Zyn authorization is commendable, it stands in stark contrast to many of its other moves. These include its shameful record of fearmongering and stoking misinformation about nicotine.
Then there are its rejections of countless vaping products: After years of PMTA applications, only a short list of vapes, often outmoded and unpopular, have been authorized. Despite the established importance of flavors in attracting adults to safer products—now belatedly reflected in the Zyn decision—just a handful of menthol-flavored vapes have been authorized. The rest are in tobacco flavor only.
A more recent example is the FDA’s renewed proposal to mandate the reduction of nicotine in combustible cigarettes to negligible levels. This plan, though well-intentioned, risks undermining harm reduction. People who switch to smoking very low-nicotine cigarettes are likely to take more puffs. Many more might instead turn to an illicit market for higher-nicotine cigarettes, a scenario that would exacerbate, rather than mitigate, public health risks.
The FDA’s approval of Zyn pouches should serve as a wake-up call for policymakers. Harm reduction is not about coercing people to quit smoking; it’s about offering them viable and safer alternatives. Rather than pursuing heavy-handed restrictions, the FDA should double down on encouraging the development and availability of reduced-risk options like pouches, vapes and heated tobacco.
The FDA’s broader tobacco strategy must change. Harm reduction must take precedence over punitive measures and scare tactics.
Globally, countries that embrace harm reduction have seen remarkable public health benefits. Sweden, for example, has the lowest smoking rates in Europe—and the lowest rates of lung cancer, and smoking-related deaths—thanks largely to the widespread use of snus, a smokeless tobacco product similar in principle to nicotine pouches.
The FDA’s decision to authorize ZYN nicotine pouches brings the US one step closer to adopting this successful model, with a more pragmatic, science-based approach to tobacco control.
However, the FDA’s broader tobacco strategy must change. Policies that prioritize harm reduction must take precedence over punitive measures and scare tactics. Public health is best served not by trying to force people to quit smoking at all costs, but by providing them with tools and information to make their own informed decisions.
The FDA must build on its welcome Zyn authorization by embracing a consistent harm reduction framework that prioritizes people who smoke, reduces risks and avoids unintended consequences. Only then can we hope to see a meaningful, accelerated reduction in smoking-related deaths and diseases.
Photograph by Aphis Marta via Wikimedia Commons/Creative Commons 4.0
Swedish Match, Zyn’s manufacturer, is a subsidiary of Philip Morris International. The Influence Foundation, which operates Filter, has received unrestricted grants from PMI. Filter also received a one-off donation from the Taxpayers Protection Alliance, the author’s employer, to support travel to a harm reduction event. Filter‘s Editorial Independence Policy applies.
