At the Next Generation Nicotine Delivery conference in Miami this week, Dr. Jessica Zdinak presented on APPH, population-level benefits, and navigating switching studies in the context of Glas's recent authorization.

A few things worth highlighting:

→ APPH is not a fixed standard. It is a risk-benefit ratio, and the threshold shifts based on your product, your population, and the evidence you bring. "If you want to get a flavored ENDS product authorized, you have to demonstrate superiority of your flavors above tobacco."

→ Age-gating reshapes the risk-benefit picture. For products with reduced youth access risk, the bar for demonstrating population-level benefit looks different, but the obligation to show it does not go away.

→ This applies across all product categories. Anyone submitting a PMTA needs to demonstrate population-level benefit, and the right study design depends on where your product sits on the risk side of that ratio. Knowing which methodological levers to pull, and when, is the difference between a well-positioned application and a deficiency letter.

The Glas authorization is a meaningful precedent. Understanding what went into it, and why, matters for anyone navigating a flavored ENDS application right now.

If you are considering a PMTA, there is more clarity now than ever before and we are here to help. If you have already submitted an application and are missing this type of evidence, it is not too late to address it. Reach out to our team.