On June 30, The U.S. Food and Drug Administration authorized 20 ZYN nicotine pouch products to carry a specific “modified risk” statement. This means that in the US, ZYN can now claim that “using ZYN instead of cigarettes reduces the risk of oral cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The decision does not mean that nicotine pouches are safe or approved as smoking cessation products. It simply allows Swedish Match, which makes ZYN, to market certain products as a less harmful alternative for adults who quit smoking completely.

The regulatory green light comes at a time when the rise of nicotine pouches has already reshaped the conversation about alternatives to smoking. Nicotine pouches have become one of the fastest growing nicotine categories globally, driven by their discreet nature, lack of smoke or vapor and the growing perception that they represent a “cleaner” way of nicotine consumption.

According to a recent report from 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 how quickly the category is growing.

The FDA announcement comes as the WHO warns that nicotine pouches are spreading so quickly that regulation is struggling to keep pace in many countries, and that brands are increasingly using social media, influencers and youth-targeted marketing to promote them.

It’s the first time regulators have formally endorsed an idea that many younger nicotine users had already embraced. However, it is not a blessing for the category. In many ways, regulators are simply playing catch-up with a cultural shift that has already occurred.

Nicotine and Tobacco Alternatives to Cigarettes

The market for smoking alternatives has fragmented far beyond what was offered 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 quickly become one of the fastest growing categories. ZYN and other brands like On! and VELO have become leaders in the oral nicotine market worldwide.

Meanwhile, vaporizers and disposable e-cigarettes continue to take up the majority of the global smoking alternatives category, which is projected to reach $14.8 billion by 2030 in the U.S., even though they are still dogged by headlines about youth use. Heated tobacco devices, such as IQOS, offer another option by heating tobacco rather than burning it, reducing exposure to many of the harmful chemicals found in cigarette smoke.

New FDA Rule on ZYN Nicotine Pouches

Public health officials remain cautious about nicotine pouches. The WHO has warned that they are becoming increasingly popular among teenagers and young adults due to their “strong youth appeal and high addiction potential”, raising concerns that products initially marketed to smokers could also attract new users.

However, based on toxicology data, consumer research, and public health modeling, the FDA issued a Modified Risk Tobacco Product (MRTP) order for 10 flavors of ZYN in 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 completely quit smoking.

The new designations are a big victory for the tobacco industry, but there are two important caveats.

First, the ruling only applies to 20 specific products, not all nicotine pouches. Second, the FDA’s findings only apply to smokers who completely switch to these bags.

Those who use cigarettes or vaporizers in addition to pouches will not get the same benefit, and the FDA has advised non-smokers not to use nicotine pouches. “FDA’s review of modified risk products aims to ensure that adult users have clear, science-based information about the relative harms of tobacco products so they can make informed decisions,” 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 track real-world use and report to the FDA. The MRTP order is valid for five years, unless renewed or withdrawn.

The FDA’s message is relatively simple: Adults who smoke and completely switch to certain nicotine pouches are likely to reduce their health risks compared to continuing to smoke cigarettes.

But the agency also emphasizes that no tobacco product is safe and that completely quitting 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 an entirely different question.

This story originally appeared on WIRING Middle East.