The FDA Ruled That ZYN Pouches Are Safer Than Cigarettes. That Doesn’t Mean They’re Safe

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.”

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.

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.