11/11/2026
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11/11/2026
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DUBAI, Nov 11: The US Food and Drug Administration (FDA) has authorized 20 variants of ZYN nicotine pouch products to be marketed as Modified Risk Tobacco Products (MRTPs), allowing specific claims that their use instead of cigarettes is associated with a lower risk of certain smoking-related diseases.
Philip Morris International (PMI), which owns the ZYN brand, announced that the FDA had issued the modified-risk orders covering the 20 product variants.
According to the authorization, the company can communicate the following claim in the United States for the approved products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The FDA's decision follows a review of applications and scientific evidence submitted by the company. The agency determined that the products met the requirements under Section 911 of the US Federal Food, Drug, and Cosmetic Act for modified-risk tobacco products.
The authorization applies specifically to the approved products and the permitted modified-risk claim. It does not mean that nicotine pouches are risk-free or that the FDA has approved them as safe.
Findings on cigarette consumption
Data reviewed by the FDA included information on adults who smoke cigarettes and subsequently began using ZYN nicotine pouches.
According to the findings cited in the company's announcement, more than half of the surveyed users reported that they had not smoked cigarettes during the previous 30 days.
Among those who continued smoking after starting to use ZYN, 80.7% reported reducing their cigarette consumption, while 57.2% said they had cut their daily cigarette use by more than half.
These findings formed part of the evidence considered in the FDA's assessment of the products' potential to reduce exposure to harmful substances associated with cigarette smoking.
How nicotine pouches differ from cigarettes
Unlike conventional cigarettes, which burn tobacco and produce smoke that users inhale, ZYN nicotine pouches deliver nicotine through absorption in the lining of the mouth.
The absence of tobacco combustion reduces exposure to many harmful and potentially harmful chemicals associated with cigarette smoke.
However, nicotine remains an addictive substance, and the FDA's modified-risk authorization should not be interpreted as an endorsement of nicotine use by non-smokers or as a declaration that the products are harmless.
The FDA's authorization permits the specified modified-risk claims for the 20 approved ZYN variants in the United States.
