Abstract: According to the National Youth Tobacco Survey (NYTS), over 3 million U.S. youth reported using a commercial tobacco product in 2022. The most used tobacco product in middle and high school aged students were e-cigarettes with 85% using flavored (I.e., menthol, mint, clove or spice, alcoholic drinks, candy, fruit, chocolate, or any other flavor other than tobacco) e-cigarettes. The Food and Drug Administration’s Premarket Tobacco Application (PMTA) authorization decisions are based on a public health standard that considers the risks and benefits of the product on the population. To date, the agency has not authorized any flavored e-cigarettes and denied millions of applications due to lack of evidence demonstrating an added benefit to adult smokers that outweighs the substantial risk of youth initiation and use of flavored e-cigarette products. The tobacco industry has few options to provide evidence that flavored e-cigarette products benefit adult smokers and outweigh the risk of youth initiation and use. One potential option is age verification technology. Tobacco manufacturers are considering and, in some cases, have developed technology to solve a problem that predates the Family Prevention and Tobacco Control Act keeping tobacco products out of the hands of underage purchasers. This poster tackles the enduring challenge of preventing youth access to Electronic Nicotine Delivery Systems (ENDS) though age gating technology with insight informed by the agency’s strategies for medical device software technology. It covers ISO standards for software development and delves into the risk-benefit balance in the design parameters of ENDS software, specifically targeting the restriction of youth access. Additionally, it shares valuable lessons gleaned from actual user study focused on age-gating technologies for e-cigarettes.

Lillian Ortega, Lise Fraissinet, Ed Carmines, Bryan Burd, Kevin Burd

Affiliations: Chemular, Inc, Hudson, MI, USA