On June 30, the US Food and Drug Administration (FDA) authorized 20 ZYN nicotine pouch products to carry a specific “modified risk” claim, according to WIRED. This means 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 Ruling and Its Scope
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 FDA’s review was based on toxicology data, consumer research, and public health modeling. However, there are two significant caveats, WIRED reports: 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.
Market Context and Global Growth
The regulatory green light comes at a time when the nicotine-pouch boom has already reshaped the conversation about alternatives to smoking, according to WIRED. 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 (WHO), 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. The WHO has also warned that nicotine pouches are becoming increasingly popular among adolescents and young adults because of their “strong youth appeal and high addiction potential.”
Caveats and Regulatory Implications
The new designations are a big win for the tobacco industry, but they are not a blanket approval. Public health officials remain cautious about nicotine pouches. The decision represents 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, WIRED notes. The market for smoking alternatives now includes oral nicotine pouches (ZYN, On!, VELO), vapes and disposable e-cigarettes (projected to hit $14.8 billion by 2030 in the US), and heated tobacco devices like IQOS. The FDA’s ruling applies only to the 20 specified ZYN products; other brands and products are not covered.
Compliance Considerations for Trade and Product Safety Professionals
For trade compliance officers and product safety regulators, this ruling underscores the need for careful review of modified risk claims and product classifications. Companies importing or distributing nicotine pouches must ensure that any marketing claims align with FDA authorizations. The ruling does not change customs or duty classifications but may affect labeling requirements and import documentation in jurisdictions that recognize FDA MRTP orders. The WHO’s concern about rapid global spread highlights the importance of monitoring regulatory developments in other countries, as many are still developing rules for nicotine pouches. Companies should also verify that their products are not marketed to youth, as this could lead to enforcement actions regardless of FDA authorization.
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