How much evidence is needed before regulators can recognise that one nicotine product carries less risk than another?
In his recent article, Are nicotine pouches safer?, Dr Charles A. Gardner raises this question in relation to the absence of long-term epidemiological data on nicotine pouches. His argument is that scientific assessments should draw on what is already known about toxic exposure and the mechanisms of smoking-related disease, even while longer-term evidence continues to develop.
For adults who smoke, the relevant comparison is often between continued cigarette use and switching completely to a non-combustible alternative.
What the Absence of Combustion Tells Us
Cigarette smoking causes serious disease largely through repeated exposure to toxic substances produced by burning tobacco. These include carcinogens, carbon monoxide and particles inhaled into the lungs.
Nicotine pouches operate differently. They deliver nicotine through the oral mucosa without burning tobacco or requiring inhalation. Gardner argues that removing these major sources of exposure provides a strong scientific basis for expecting substantially lower risks than continued smoking.
This reasoning is consistent with established differences between combustible and non-combustible nicotine products. However, reduced exposure does not establish the precise magnitude of long-term disease reduction. Nicotine remains addictive, and questions about cardiovascular effects, oral health and prolonged pouch use require continued investigation.
Gardner proposes that complete switching could reduce smoking-related mortality by 90–95%. That figure should be understood as his hypothesis based on existing evidence and biological reasoning, rather than a directly measured outcome from long-term nicotine pouch studies.
What the FDA’s Assessment Establishes
Regulatory evidence offers further context.
In January 2025, the US Food and Drug Administration authorised the marketing of 20 ZYN nicotine pouch products following scientific review. The agency found that these specific products contained substantially lower levels of harmful constituents than cigarettes and most smokeless tobacco products, supporting its assessment that they posed lower risks of cancer and other serious health conditions.
The decision also considered evidence of complete switching among adult tobacco users and potential risks to young people.
Importantly, the authorisations applied only to the products reviewed. They did not constitute FDA approval as smoking-cessation medicines or permission to market the products with reduced-risk claims.
The FDA’s wider guidance nevertheless recognises that nicotine pouches can generally offer a lower-risk alternative for adults who smoke, particularly when cigarettes are replaced completely.
Assessing Risk While Evidence Develops
Gardner’s article highlights a genuine challenge in public-health decision-making. Long-term epidemiological studies are valuable, but their absence does not make existing toxicological and regulatory evidence irrelevant.
At the same time, confidence in relative risk should be proportionate to the strength of the available evidence. Findings about reduced exposure, estimated disease risk and observed long-term health outcomes are related, but they are different forms of evidence.
For GINN, this distinction is central to risk-proportionate regulation. Policymakers should recognise meaningful differences between combustible and non-combustible products while requiring appropriate manufacturing standards, youth protections and post-market surveillance.
The evidence supports treating nicotine pouches differently from cigarettes in assessments of relative risk. It does not justify treating every pouch product as equally safe or assuming that the long-term health effects are fully understood.
The policy question is how to act responsibly on the evidence available today while continuing to strengthen it.
Sources
- Gardner, Charles A. (2026). Are nicotine pouches safer?. Medium. Original commentary credited and discussed in this article.
- US Food and Drug Administration (16 January 2025). FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review.
- US Food and Drug Administration. The Relative Risks of Tobacco Products.
