FDA Authorizations for Smoke-Free Alternatives Advance Tobacco Harm Reduction
The United States Food and Drug Administration (FDA) has made significant strides in the fight against tobacco-related harm by authorizing the marketing of various smoke-free alternatives to conventional cigarettes. In January 2025, the FDA authorized 20 ZYN nicotine pouch products, recognizing their potential to present a lower risk of cancer and other health conditions compared to traditional cigarettes.
ZYN joins a growing list of FDA-authorized alternative products, many of which are considered by the agency as “appropriate for the promotion of public health.” This list includes electronic cigarettes, with the FDA authorizing 4 menthol-flavored e-cigarettes in June 2024. The scientific evidence presented by the manufacturing company demonstrated that these menthol-flavored products provided a benefit to adult smokers compared to previously authorized tobacco-flavored products, offsetting the risks associated with the product.
Since 2021, the FDA has permitted the marketing of electronic cigarette products, with the first authorization granted in October of that year. To date, the agency has received applications for more than 27 million considered products and has resolved over 26 million of these applications, authorizing 27 tobacco and menthol-flavored electronic cigarette products and devices. (updated: 34 products approved till now)
Dr. Matthew Farrelly, Director of the Office of Science at the FDA’s Center for Tobacco Products, emphasized the agency’s commitment to following the science in their review of premarket applications. He stated, “Based on our rigorous scientific review, in this case, the strength of the evidence on the benefits to adult smokers of completely switching to a less harmful product was sufficient to outweigh the risks to youth. This action further reinforces that authorization of an electronic cigarette product is possible when sufficient scientific evidence has been presented to the agency to justify it.“
The FDA has also authorized previous versions of the IQOS tobacco heating device, specifically IQOS 3 and IQOS 2.4, as Modified Risk Tobacco Products (MRTP) between 2020 and 2022. This designation indicates that the modification of risk exposure of both products “is appropriate to promote public health,” according to the FDA. Findings suggest that completely switching from conventional cigarettes to the IQOS device significantly reduces exposure to harmful or potentially harmful substances by an average of 95%.
However, it is important to note that IQOS is not a risk-free product, as it delivers nicotine, which is addictive. The product is intended for adult smokers who would otherwise continue smoking conventional cigarettes and is not recommended for non-smokers, minors, or other vulnerable groups.
The main characteristic shared by these alternative products is the absence of smoke, which science has confirmed as the principal cause of tobacco-related harm. By authorizing these smoke-free alternatives, the FDA is acknowledging their potential to reduce the risks associated with conventional cigarettes and promote public health.
As the FDA continues to review premarket applications for alternative tobacco products, it remains committed to following the science and making data-driven decisions. The authorization of these smoke-free alternatives represents a significant step forward in the ongoing effort to reduce tobacco-related harm and provide adult smokers with potentially less harmful options.
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