The FDA has ruled that ZYN pouches are safer than cigarettes. This does not mean that they are safe

On June 30, The FDA has allowed 20 ZYN nicotine pod products to carry a specific “modified risk” claim. This means that in the United States, ZYN can now confirm 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 to adults who are turning away from cigarettes completely.

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 from the World Health Organization, global retail sales of nicotine pods will reach 23.4 billion units in 2024, an increase of more than 50 percent from the previous year, underscoring how quickly this category is growing.

The FDA’s announcement comes as the World Health Organization warns that nicotine pouches are spreading so quickly that regulation is struggling to keep up 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 officially endorsed an idea that many younger nicotine users have already embraced. However, it is not a boon for this category. In many ways, regulators are simply playing catch-up to a cultural shift that has already occurred.

Nicotine and tobacco substitutes for cigarettes

The smoking alternatives market has fragmented far 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 nicotine replacement products.

Oral nicotine pods are quickly becoming one of the largest growth categories. ZYN and other brands like On! VELO has become a leader in the global oral nicotine market.

Meanwhile, e-cigarettes and disposable e-cigarettes still account for the largest share of the global smoking alternatives category, and are expected to reach $14.8 billion by 2030 in the United States, although they are still dogged by headlines about youth use. Heated tobacco devices, such as IQOS, provide another option by heating tobacco rather than burning it, reducing exposure to many of the harmful chemicals found in cigarette smoke.

New FDA ruling on ZYN nicotine pouches

Public health officials remain cautious about nicotine pouches. The World Health Organization has warned that it has become increasingly popular among teenagers and young adults due to its “strong appeal among young people and high addictive potential”, raising concerns that products initially marketed to smokers could also attract new users.

Based on toxicology data, consumer research, and public health modeling, the FDA issued a Modified Risk Tobacco Product (MRTP) application for 10 ZYN flavors in each of two strengths – 3 milligrams and 6 milligrams. This allows Swedish Match to market those specific products as a less risky alternative to adults who are staying away from cigarettes completely.

The new designations are a big win 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 switch completely to these pouches.

Those who use cigarettes or e-cigarettes as well as pouches will not get the same benefit, and the US Food and Drug Administration has advised non-smoking users not to use 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 Brett Koplow, acting director of the FDA’s Center for Tobacco Products. He also stated that the decision “informs adults who smoke of the lower risks associated with these products.” Swedish Match must also track real-world use and report to the FDA. An MRTP order is valid for five years, unless renewed or withdrawn.

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

But the agency also stresses that no tobacco product is safe and that completely quitting all tobacco and nicotine products remains the best option for better health. Who will eventually use nicotine pouches — and whether their rapid growth creates a new generation of nicotine users — is an entirely separate question.

This story originally appeared on Wired Middle East.