A decision by the Food and Drug Administration (FDA) to authorize fruit-flavored e-cigarettes has reignited one of the most contentious debates in tobacco control: whether flavored vaping products represent a dangerous gateway for youth or a valuable tool for adults.
The agency recently authorized flavored vaping products equipped with age-verification technology and announced it would relax enforcement priorities for flavored products with pending applications. The moves drew concern from some public health organizations, warning that the decisions could undermine progress in reducing youth vaping.
But tobacco researchers at MUSC Hollings Cancer Center say the issue is more complicated than the public conversation often suggests.
“We fought very hard to get science-based regulation of tobacco products,” said Hollings tobacco researcher Kenneth Michael Cummings, Ph.D. “If we want science-based regulation, then we need to listen to the FDA’s scientists about whether a product is appropriate for the protection of public health.”
Cummings emphasized the reality underlying the FDA’s decision: While vaping products are not harmless, they are much less dangerous than combustible cigarettes for adults who switch completely.
“For adult smokers, switching to vaping reduces their risk of developing serious health problems like lung cancer because it can help them move away from deadly cigarettes,” he said. “Studies done at MUSC and elsewhere show that vapes can help people quit smoking and may work as well or better than nicotine replacement products.”
At the same time, researchers stress that concerns about youth vaping are well-founded, especially because flavored products are known to appeal to adolescents as well as adults.
The newly authorized products address that concern through built-in age-gating technology designed to limit youth access. The devices require users to connect through a smartphone app that verifies their identities, using government-issued identification and occasional biometric rechecks, such as facial recognition, before the products can be used.
If age-gating really works, then it seems like another way manufacturers can demonstrate low risk to youth for products that may provide a benefit to adults who smoke.
“Although flavored e-cigarettes may help adults who smoke cigarettes to switch at higher rates than tobacco- and menthol-flavored e-cigarettes, the fact that these nicotine products may be more appealing to children, adolescents and young adults is an issue,” said Benjamin Toll, Ph.D., co-director of the Lung Cancer Screening Program and director of the Tobacco Treatment Program.
Toll said a lack of publicly available data and peer-reviewed studies on the products’ age-gating technology leaves questions about how effective the safeguards are in practice. While FDA scientists reviewed proprietary company data before authorizing the products, outside researchers have not yet independently evaluated the technology. Toll noted that researchers generally approach new tobacco products like this with a degree of caution.
“The data regarding age-gating has not been released to the public, so until we see that data, I remain concerned about youth uptake of flavored e-cigarettes,” he added.
Tracy Smith, Ph.D., an addiction scientist and co-leader of the Cancer Prevention and Control Research Program at Hollings, said the safeguards nevertheless distinguish the new products from many flavored vaping devices already widely available.
“On its face, I don’t think it’s a bad decision,” Smith said of the FDA authorization. “If age-gating really works, then it seems like another way manufacturers can demonstrate low risk to youth for products that may provide a benefit to adults who smoke.”
Smith noted that unauthorized flavored vaping products remain widely accessible to youth despite years of enforcement efforts.
“There are flavored illicit products already on the market that are much easier for youth to access than these products that have age-gating technology,” Smith said.
Cummings added that even with easy access to illicit flavored products, vaping prevalence among teenagers has declined since its peak in 2019, suggesting that access to flavored vapes is not necessarily the main driver of youth vaping.
That fact highlights a central tension in the vaping debate: Regulators are trying to reduce youth nicotine use while also addressing the enormous health burden caused by combustible cigarettes, which continue to kill hundreds of thousands of Americans each year.
“The real health problem at hand is the millions of adult smokers who need to get off cigarettes immediately,” Cummings said. “I believe authorizing flavored vapes will help more adult smokers abandon deadly cigarettes for a safer alternative.”
Hollings researchers are actively examining this issue. Smith and colleagues are leading a nationwide randomized controlled study of 1,500 participants comparing quit rates among three groups of cigarette smokers: those who can choose fruit- or menthol-flavored vaping products, those who are limited to tobacco-flavored vaping products and those who are given nicotine replacement therapy. The findings could help to answer a key question at the center of the debate: Do flavored products improve the likelihood that adult smokers successfully transition away from cigarettes?
Still, researchers emphasize that strong oversight will be essential. The FDA decision does not eliminate concerns about youth marketing or the health effects of vaping. Rather, it underscores a difficult balancing act, where alternatives to cigarettes may help adults to quit smoking while still posing risks for youth addiction and public health.
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K. Michael Cummings, Ph.D.
Dr. Cumming's training and research interests are in the study of health related behaviors, especially tobacco use prevention and cessation. His research is primarily population based with a focus on smoking cessation, consumer risk perceptions, the impact of cigarette design on smoking behaviors, and the evaluation of public policies on tobacco use behaviors. Recognized internationally for his work in tobacco epidemiology and smoking cessation, Dr. Cummings has guided global public policy and regulations in the marketing and distribution of nicotine products. This work has involved designing studies to understand factors involved in predicting uptake and cessation of tobacco use and the testing of interventions to alter tobacco use behaviors at both the individual and population level. In 2002, Dr. Cummings established the International Tobacco Research Policy Evaluation Project (ITC Project) to evaluate the behavioral impacts of national level tobacco control policies implemented as part of the WHO Framework Convention on Tobacco Control (FCTC). This international project began in 2002 and involves over 100 scientific colleagues from more than 20 countries and includes a wide range of research projects ranging from those focused on biological factors that influence tobacco use to the impact of health warnings and public education campaigns on representative populations of smokers. As part of his work with the ITC Project he has served as the PI on three large multi-institutional NIH grants (P50 CA111236: 2004-2009, P01 CA138389: 2009-2016, P01 CA200512: 2016-2021). Data from the ITC Project has become an important source of the evidence base used by governments and public health advocates to support tobacco control policy initiatives around the world. Over his 35-year career he has directed more than 70 grants and contracts and has published over 430 scientific papers including landmark reports for the Office of the Surgeon General, the National Cancer Institute, the International Agency for Research on Cancer, and the Institute of Medicine.
Tracy Smith, Ph.D.
Associate Professor, College of Medicine - Psychiatry & Behavioral Sciences
The overarching goal of my research is to test policies and interventions with the goal of reducing the prevalence of smoking and tobacco-related cancer. One arm of my research focuses on tobacco product regulations that reduce the addictiveness and appeal of cigarettes. Over a decade of my work has documented that public health could be improved with a policy that requires a reduction in the nicotine content of cigarettes. Further, one of my ongoing research projects focuses on the impact of a cigarette menthol ban on smoking behavior. Another arm of my research focuses on whether noncombustible tobacco products, like e-cigarettes, can serve as harm reduction tools among adults who smoke cigarettes. I have several ongoing clinical trials testing the harm reduction potential of alternative tobacco products.
Benjamin Toll, Ph.D.
Professor & Vice Chair, Public Health Sciences
Associate Director, Hollings Education & Training
Co-Director, Hollings Lung Cancer Screening Program
Director, MUSC Health Tobacco Treatment Program
Benjamin Toll, Ph.D., a professor of public health sciences and psychiatry at MUSC, specializes in the treatment of tobacco use disorders and improvement of health behaviors. As associate director, his goal is to provide well-structured and effective education and training opportunities for pre- and post-doctoral students and junior faculty at Hollings Cancer Center.