By Timothy S. Donahue

Top Takeaways:

• Glas case study: Zdinak says communication and behavioral science helped secure authorization
• Population benefit: Every successful MGO has demonstrated benefits to adult tobacco users
• FDA perspective: Manufacturers must understand the pressures and constraints facing CTP reviewers

Science may be the foundation of a successful premarket tobacco product application (PMTA), but according to Jessica Zdinak, it is only part of what gets a product across the finish line.

Speaking at the Next Generation Nicotine Delivery 2026 conference in Miami, Zdinak, founder and CEO of Applied Research and Analysis Consulting (ARAC), used the recent authorization of Glas vaping products as a case study to argue that manufacturers must combine strong science, consumer understanding, and effective communication to secure marketing-granted orders (MGOs).

“We fundamentally believe that in order to get a successful MGO or MGOs, you have to take three things into consideration,” Zdinak said. “You have to take your regulator, their position, where they’re coming from. You have to understand the consumer in and out, and then you have to make sure your innovation, your product development is really at the foundation of your product.”

ARAC is a clinical and behavioral science research firm specializing in product use behavior, clinical studies, population modeling, and post-market surveillance. A major focus of Zdinak’s presentation was the role of behavioral science in demonstrating that a product is appropriate for the protection of public health (APPH), the statutory standard the U.S. Food and Drug Administration uses when reviewing PMTAs.

Zdinak outlined Glas’ review process, which spanned more than four years, from PMTA submission in March 2021 to final authorization in 2025. The company received multiple deficiency letters during review, including requests for a switching study demonstrating population-level benefit. ARAC later conducted the study.

“Every single time CTP said and communicated specifically through deficiencies that a study was needed and warranted, they did it,” she said.

But Zdinak argued that science alone was not the entire story.

“What Glass did really well was they broke through, in my opinion, this tension and this confusion about PMTAs, and they did it through communication,” she said.

Throughout the presentation, she repeatedly urged manufacturers to better understand the challenges that FDA reviewers face. “I think that’s what makes our contributions beneficial,” she said, referring to ARAC’s experience working across industry, research and government environments.

Zdinak described FDA reviewers as scientists operating under legal mandates, funding constraints, political pressure, and an increasingly contentious regulatory environment.

One of the strongest messages from the session focused on actual-use and behavioral data. Zdinak noted that every product receiving an MGO to date has included some form of actual-use, product-use, or behavioral evidence demonstrating population-level benefit.

“We know that every single MGO had some level of actual use or product use behavioral data in their application,” she said. “Every single one of them.”

She argued that manufacturers focusing solely on toxicology, chemistry, and engineering data may be overlooking a critical part of the authorization equation. “If you start an application and move forward without some type of actual use data when people are using the product, we’ll see how that ends up as far as an MGO or MDO,” Zdinak said.

According to Zdinak, the FDA consistently focuses on whether manufacturers can demonstrate that benefits to adult tobacco users outweigh risks to youth and nonusers. “The standard set by law requires FDA to consider the risks and benefits to the U.S. population as a whole, including the benefits to adults who currently use tobacco products and switch, and that they outweigh the risks to non-users and to youth,” she said.

When asked about dual use and partial switching, Zdinak emphasized that reducing smoking can still yield meaningful benefits even when smokers do not fully quit immediately. “Every single smoker has a different journey to cessation,” she said.

She cited the FDA’s focus on a 50% or greater reduction in cigarettes per day among heavier smokers as evidence that meaningful reductions can yield measurable benefits. “In our camp, quitting smoking is the best win ever, regardless of how you get there,” Zdinak said. “If you’re a heavy smoker and you’re reducing by roughly 50%, they, as an individual, are receiving that quality of life benefit.”

For manufacturers navigating the PMTA process, Zdinak’s message was clear: understand your consumer, understand your regulator, and build the behavioral evidence needed to demonstrate that smokers actually benefit from switching.

“Let’s actually do what they’ve asked us to do,” she said, “which is give them evidence that your target audience and population, specifically smokers, are going to transition and use a less harmful product.”