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News — WASHINGTON – A rigorous, comprehensive synthesis of evidence from 62 studies related to the use of oral nicotine pouches by Georgetown University’s Lombardi Comprehensive Cancer Center scientists and colleagues provides a much-needed assessment of how these products could lead to potential harmful consequences if used by young people.

Oral nicotine pouches were first introduced in the U.S. in the past decade and are pre-portioned white granular packets containing nicotine placed between the gums and lips, marketed as tobacco-free, and are sold in various flavors and nicotine strengths.

The findings appeared in Nicotine and Tobacco Research on June 17, 2024.

“Oral nicotine pouches are rapidly increasing in popularity. While they may present a less harmful nicotine alternative for cigarette users, there is considerable concern about them becoming a new form of nicotine dependence, especially in youth who don’t use tobacco or nicotine,” says the study’s corresponding author Nargiz Travis, MSPH, Project Director for the Center for the Assessment of Tobacco Regulations (CAsToR) at Georgetown Lombardi. “As with electronic cigarettes, the wide variety of flavors and aggressive marketing campaigns that we are seeing, especially via social media, have the potential to appeal to youth, providing a new pathway to nicotine dependence.”

The investigator’s analysis was based on 45 academic and 17 industry-funded studies, mostly from the U.S. Sales of the products have been concentrated in Scandinavia and the U.S., mainly because of the established smokeless tobacco market in these regions.

In the U.S., the researchers found, based on nationally representative surveys, that through 2023, oral nicotine pouches were currently used by 1.5% of all youth while lifetime use by young people was under 2.5%. In terms of awareness of the products, between 35% to 42% of U.S. adolescents and young adults have heard of oral nicotine pouches and 9% to 21% of tobacco-naïve (non-tobacco users) youth surveyed were not opposed to trying them. U.S. adult usage estimates varied widely across surveys; in 2023, 0.8-3% of Americans currently used the products while 3-16% used them at some point in time. In view of rising nicotine pouch sales trends in 2024, their use in the U.S. population has likely increased.

The investigators’ findings suggest fewer harmful chemical compounds are present in the pouches and occur at lower levels than in cigarettes and smokeless tobacco, with the exception of formaldehyde. However, an analysis of 37 oral nicotine pouches of different brands, nicotine strengths, and flavors yielded a wide range of total nicotine content from 0.89 to 6.73 milligrams per pouch.

“Because oral nicotine pouches do not contain tobacco leaves, they are often marketed as tobacco-free, but we found that descriptor may confuse the understanding of the source of nicotine and may be associated with the perception that they are not as harmful as other tobacco products,” says Travis. “In the U.S., oral nicotine pouches are currently neither authorized by the FDA for marketing as a modified-risk product nor approved as a cessation product. It is important to know that nicotine is an addictive chemical with harmful health effects, regardless of whether it is synthetic, meaning tobacco-free, or derived from tobacco.

One of the studies included in the authors’ analysis was a U.S. survey of young adults 18-34 years of age, many of whom used cigarettes and e-cigarettes. The survey found that among those who had tried nicotine pouches, curiosity about the product (28%), flavors (26%), and the ability to use in places where other tobacco products are prohibited (26%) were among the main reasons for trying the pouches. The availability of flavors (31%) was the main motive for use in another U.S. sample of adult current nicotine pouch users.

Leading brands of the products are currently owned by major tobacco companies. The authors note that a substantial investment in marketing by the companies suggests that oral nicotine pouches are becoming increasingly important to the tobacco industry.

“As more evidence on oral nicotine patches becomes available, and more importantly, more independent studies become published, it will

be essential to conduct further analyses comparing the findings of industry vs. non-industry sponsored research and critically assess the quality and risk of bias of such studies,” concludes Travis.

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Other authors in addition to Travis include Hayoung Oh, Radhika Ranganathan and David Levy at Georgetown Lombardi Comprehensive Cancer Center. Kenneth Warner is at the University of Michigan; Rafael Meza is at the BC Cancer Research Centre, Vancouver, Canada; Maciej Goniewicz is at Roswell Park Comprehensive Cancer Center, Buffalo, NY; and Jamie Hartmann-Boyce is at the University of Massachusetts Amherst.

This work was supported by National Cancer Institute and Food and Drug Administration grant #U54CA229974.

Goniewicz received a research grant from Pfizer and served as a member of the scientific advisory board to Johnson & Johnson. The other authors declared no conflicts of interest related to the study.

About Georgetown University’s Lombardi Comprehensive Cancer Center

Georgetown’s Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute (NCI) as a comprehensive cancer center. A part of Georgetown University Medical Center, Georgetown Lombardi is the only comprehensive cancer center in the Washington D.C. area. It serves as the research engine for MedStar Health, Georgetown University’s clinical partner. Georgetown Lombardi is also an NCI recognized consortium with John Theurer Cancer Center/Hackensack Meridian Health in Bergen County, New Jersey. The consortium reflects an integrated cancer research enterprise with scientists and physician-researchers from both locations. Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic, translational and clinical research, patient care, community education and outreach to service communities throughout the Washington region, while its consortium member John Theurer Cancer Center/Hackensack Meridian Health serves communities in northern New Jersey. Georgetown Lombardi is a member of the NCI Community Oncology Research Program (UG1CA239758). Georgetown Lombardi is supported in part by a National Cancer Institute Cancer Center Support Grant (P30CA051008). Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer).

About Georgetown University Medical Center

Georgetown University Medical Center (GUMC) is an internationally recognized academic health and science center with a four-part mission of research, teaching, service and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health.  Connect with GUMC on Facebook  (Facebook.com/GUMCUpdate) and Twitter (@gumedcenter).