FDA Grants Modified-Risk Status to ZYN Nicotine Pouches Amid Rapid Market Growth and Youth-Use Concerns

On June 30, 2024, the U.S. Food and Drug Administration issued a Modified Risk Tobacco Product (MRTP) order for 20 ZYN nicotine-pouch products. The order permits Swedish Match to market ten flavors at two nicotine strengths—3 mg and 6 mg—with a claim that adult smokers who fully switch face a lower risk of several serious diseases.

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Oral nicotine pouches have become a rapidly expanding segment of the nicotine market. A WHO report noted 23.4 billion units sold worldwide in 2024, a rise of over 50 percent from the prior year. ZYN, On! and VELO lead the category, which now competes with traditional nicotine-replacement therapies and the larger disposable e-cigarette market.

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The FDA stresses that the modified-risk claim applies only when adults completely replace combustible cigarettes with ZYN, and it does not constitute an endorsement of safety or approval for smoking cessation. The order is based on toxicology data, consumer research and public-health modeling indicating reduced exposure to many harmful chemicals relative to smoking.

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The World Health Organization warns that nicotine pouches are gaining strong appeal among adolescents and young adults, citing high addiction potential and aggressive marketing through social-media influencers. Regulators in several countries report difficulty keeping pace with the product’s rapid diffusion, fearing that a reduced-risk label could attract new, non-smoking users.

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The FDA’s assessment emphasizes reduced disease risk for adult smokers who fully transition to ZYN, while the WHO highlights youth appeal and the absence of long-term safety data. No independent studies have yet measured actual reductions in mouth cancer, heart disease or other outcomes among former smokers who adopt ZYN, leaving a gap between modeled risk reductions and real-world health impacts.

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"using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis." — FDA, MRTP claim language

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"The decision does not mean nicotine pouches are safe or approved as smoking cessation products." — FDA statement

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"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.'" — World Health Organization

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"global retail sales of nicotine pouches reached 23.4 billion units in 2024, an increase of more than 50 percent from the previous year." — WHO report

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"The FDA gave a Modified Risk Tobacco Product (MRTP) order to 10 ZYN flavors at each of two strengths—3 milligrams and 6 milligrams." — FDA order description

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The WHO warns that regulation is struggling to keep pace with the rapid spread of nicotine pouches and urges stronger international guidelines to curb youth-oriented promotion. The FDA’s MRTP order marks the first formal endorsement of a reduced-risk claim for such products, suggesting that future policy discussions will focus on balancing adult-smoker benefits with youth-use risks.

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