In light of recent FDA enforcement actions related to the Youth Tobacco Prevention Plan, we reached out to David Wourms, Senior Research Scientist at Battelle Memorial Institute, to learn more about strategies and sensitivities for data collection among youth populations with respect to the use of ENDS products.
Your presentation at this year’s ENDS conference will cover strategies and sensitivities for data collection among youth populations. Why is it important for the ENDS industry to hear this message?
Wourms: Pointing to the September 2018 announcement in which FDA Commissioner Gottlieb warned that the use of e-cigarettes has “…become an almost ubiquitous – and dangerous – trend among teens” it’s important to capture data from the youth and young adult population to better understand their risk perceptions and risk-based behavior with respect to the use of ENDS products. Simply by virtue of their age, we know young people have different thought processes, priorities, perceptions, and social habits than do most adults, and we need to fully understand these differences for industry to meet both the letter and the spirit of the FDA Youth Tobacco Protection Plan.
What are some of the key take-aways from your presentation?
Wourms: First, taking a risk-based approach to evaluation is important. Structure data collection to capture accurate user, use and use environment profiles such that you can assess factors that modulate risk perception and risky behavior. Second, while industry is generally reluctant to conduct study activities with youth, it is clear use among this population is accelerating, and that generates a need to understand this population with the same fidelity as is found in the adult population. Bottom line is that all cohorts are relevant, users/nonusers, adult/youth, etc. and youth and young adult studies can be done safely and effectively within an appropriate framework approach.
As the FDA pushes for more ENDS regulations, what do you think is the biggest concern regarding testing strategies and methodologies?
Wourms: The biggest concern for industry and independent researchers is defining what testing is necessary and sufficient to address regulatory requirements, and then providing a compelling rationale for both bridging and original research studies. Structure your methodology – including relevant cohorts – to effectively demonstrate why and how the data you capture addresses questions from a public health perspective.
What advice would you give someone that is just breaking into the ENDS market?
Wourms: Do your homework. Study all the publicly available FDA and CTP resources; paying particular attention to prior company’s submissions and the FDA response to those submissions.
Which presentations (what session topic) are you most looking forward to hearing about at ENDS?
Wourms: 'Fact or Fiction? The importance of communicating sound science on nicotine delivery products' by Sarah Cooney. Emphasizing high-quality science, and clearly communicating the results and their application, is central to the research profession.
Hear more from David about health risk assessments and behavioral testing strategies during his presentation, Strategies and Sensitivities for Data Collection Among Youth Populations, that will take place on Day 2 of the conference - December 7 - at 11:30 AM EST.