On June 30, the US Food and Drug Administration authorized 20 ZYN nicotine pouch products to carry a specific “modified risk” claim. This means that in the US, ZYN can now assert that “using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”
The decision does not mean nicotine pouches are safe or approved as smoking cessation products. It simply allows Swedish Match, which manufactures ZYN, to market certain products as a less harmful alternative for adults who completely switch away from cigarettes.
The regulatory green light comes at a time wheN the nicotine-pouch boom has already reshaped the conversation about alternatives to smoking. Nicotine pouches have become one of the fastest-growing nicotine categories globally, fueled by their discreet nature, lack of smoke or vapor, and growing perceptions that they represent a “cleaner” form of nicotine consumption.
According to a recent report by the World Health Organization, global retail sales of nicotine pouches reached 23.4 billion units in 2024, an increase of more than 50 percent from the previous year, underscoring just how quickly the category is growing.
The FDA announcement comes as the WHO warns that nicotine pouches are spreading so rapidly that regulation is struggling to keep pace in many countries, and that brands are increasingly using social media, influencers, and youth-oriented marketing to promote them.
It’s the first time regulators have formally endorsed an idea that many younger nicotine users had already embraced. It is not, however, a blessing for the category. In many ways, regulators are simply catching up with a cultural shift that already happened.
Nicotine and Tobacco Alternatives to Cigarettes
The market for smoking alternatives has splintered well beyond the offerings of a decade ago. While nicotine-replacement therapies such as patches, gum, and inhalers remain FDA-approved tools designed to help people quit smoking, they now compete with a rapidly expanding ecosystem of alternative nicotine products.
Oral nicotine pouches have rapidly become one of the biggest growth categories. ZYN and other brands like On! and VELO have become the front-runners in the oral nicotine market globally.
Vapes and disposable e-cigarettes, meanwhile, still take the biggest share of the global smoking-alternative category, projected to hit $14.8 billion by 2030 in the US, even though they’re still dogged by headlines about youth use. Heated tobacco devices, like IQOS, offer another choice by heating tobacco instead of burning it, which lowers exposure to many of the harmful chemicals found in cigarette smoke.
The FDA’s New Ruling on ZYN Nicotine Pouches
Public health officials remain cautious about nicotine pouches. The WHO has warned that they are becoming increasingly popular among adolescents and young adults because of their “strong youth appeal and high addiction potential,” raising concerns that products initially marketed to smokers could also attract new users.
Based on toxicology data, consumer research, and public health modeling, though, the FDA gave a Modified Risk Tobacco Product (MRTP) order to 10 ZYN flavors at each of two strengths—3 milligrams and 6 milligrams. This allows Swedish Match to market those specific products as a lower-risk alternative for adults who switch completely away from cigarettes.
The new designations are a big win for the tobacco industry, but there are two significant caveats.
First, the ruling only applies to 20 specific products, not all nicotine pouches. Second, the FDA’s findings only apply to smokers who fully switch to these pouches.
Those who use cigarettes or vapes as well as pouches won’t get the same benefit, and the FDA has advised non-tobacco users against using nicotine pouches. “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,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. He also stated that the decision “informs adults who smoke about the lower risks associated with these products.” Swedish Match must also keep track of real-world usage and report back to the FDA. The MRTP order is valid for five years, unless it is renewed or withdrawn.
The FDA’s message is relatively straightforward: Adults who smoke and completely switch to certain nicotine pouches are likely reducing their health risks compared to continuing to smoke cigarettes.
But the agency also stresses that there is no safe tobacco product and that fully quitting all tobacco and nicotine products remains the best option for better health. Who ultimately uses nicotine pouches—and whether their rapid growth creates a new generation of nicotine users—is a separate question entirely.
This story originally appeared on WIRED Middle East.
