ZYN and the purpose of the Modified Risk Tobacco Product pathway

A version of the following written comment was submitted to the Food and Drug Administration on January 7, 2025.

Though smoking has declined significantly in the past two decades, there are still almost 30 million adults in the U.S. who smoke, and cigarettes remain the leading preventable cause of death and disease, accounting for 480,000 deaths per year.

The Modified Risk Tobacco Product (MRTP) pathway was established under the Family Smoking Prevention and Tobacco Control Act of 2009 to address the specific public health challenge of ensuring adult smokers can access and receive accurate information about genuinely lower-risk alternatives to cigarettes while maintaining rigorous scientific standards that protect public health. This regulatory framework supports the complete cessation of all tobacco and nicotine use. Still, it recognizes there are nicotine products that are significantly less harmful than combustible cigarettes and can serve an important role in advancing public health for those who are currently unable or unwilling to stop smoking.

The MRTP pathway requires manufacturers to provide substantial scientific evidence demonstrating that a product will significantly reduce harm and risk of tobacco-related disease to individual users and that authorizing modified risk claims will benefit the health of the population as a whole, considering both current tobacco users and the potential impact on non-users, particularly youth.

Swedish Match's applications for ZYN nicotine pouch products represent precisely the type of submission for which the MRTP pathway was designed. When the Food and Drug Administration (FDA) authorized 20 ZYN nicotine pouches in January 2025 through the premarket tobacco application pathway, the agency's director of the Office of Science, Matthew Farrelly, said, "In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products." The risk that a substantial number of tobacco-naive youth will initiate ZYN use was also determined to be low, with past-month youth use of all nicotine pouch products being just 1.8 percent in 2024.

With these products confirmed as meeting the "appropriate for the protection of public health" standard, Swedish Match now seeks authorization to communicate the relative risk reduction that these smoke-free, tobacco-free oral nicotine products offer compared to continued cigarette smoking. The proposed claim-that using ZYN instead of cigarettes places users at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis-directly addresses the comparative harm profile that is central to the MRTP framework's public health goals.

Access to accurate information on the relative risks of ZYN is especially important given the widespread misperceptions of the dangers of different tobacco products among the population. The misperceptions around the risks of nicotine itself, as well as categories of nicotine products, such as e-cigarettes, are well documented, with most of the public, including smokers, incorrectly believing these products to be just as or more dangerous than combustible cigarettes.

The literature on risk perceptions is not as well-developed for nicotine pouches as it is for e-cigarettes. However, there is some evidence of misperceptions about their risks, and, in the case of ZYN products, these could be corrected through an MRTP authorization. Participants in a 2023 study covering six metropolitan areas found nicotine pouches were viewed in absolute terms to be moderately to highly harmful, and only 22 percent less harmful than cigarettes.

A separate study examining young adults' perception of and willingness to use nicotine pouches found that almost half were uncertain whether pouches were safer than cigarettes. The same study also found, perhaps unsurprisingly but reassuringly, that non-tobacco users were the least likely to consider using nicotine pouches.

Without accurate information to judge relevant trade-offs, smokers who otherwise would switch to a safer product, such as ZYN, will continue using cigarettes. These concerns are not theoretical. Following an outbreak of e-cigarette or vaping-associated lung injuries (EVALI) in 2019 -which was incorrectly attributed to nicotine e-cigarettes instead of illicit marijuana cartridges tainted with vitamin E acetate-a study by economists at Cornell University found that demand for e-cigarettes for smoking cessation fell by 30 percent.

The dangers of risk misperceptions were highlighted in the journal Addiction in August 2023 by the former director of the FDA's Center for Tobacco Products, Brian King, who argued that the agency should take a more proactive role in correcting them. "[O]pportunities exist to educate adult smokers about the relative risks of tobacco products, including e-cigarettes, using evidence-based approaches," wrote King.

Very few products have obtained MRTP authorization, the first being granted to General Snus in 2019. A small but encouraging body of literature suggests that MRTP authorization for products that meet the rigorous requirements of the pathway can have a positive public health impact. A survey of U.S. adults found that daily and frequent smokers were more likely to perceive products with a reduced harm MRTP claim as less harmful than people who have never smoked, indicating that MRTP action will have the greatest effect on the intended audience. After General Snus received MRTP status in 2019, relative to non-snus smokeless tobacco, which carries higher risks, General Snus sales increased, suggesting some substitution from smokeless tobacco to General Snus, which would be a net public health benefit. Furthermore, following General Snus's MRTP authorization, there was no increase in youth use of the product.

All MRTP authorizations are conditional and can be withdrawn if unforeseen challenges emerge. Post-market surveillance can assist the FDA in determining whether to terminate authorization. Given both the low-risk profile and low abuse liability of ZYN products, MRTP authorization is justified on the substantial merits of the application. Authorization would demonstrate the FDA's stated commitment to providing smokers with accurate information about safer alternatives.