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Dr. Douglas Ming Deng
Dr. Douglas Ming Deng is a professor and the head of NGP Studies at Yunnan University. He has presided over numerous research initiatives, focusing on topics such as the regulation of e-vapor products in Asia, the economic and societal pay-off of introducing heated tobacco products, and the significance of leaf tobacco in the NGPs era. Dr. Deng’s recent research pursuits encompass the evolutionary study of the transition from combustible cigarettes to NGP, as well as the innovation of NGP through consumer-centric r&d. Additionally, Dr. Deng actively participates as a speaker at prominent tobacco industry forums, including the GTNF.
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Dr. Jessica Zdinak
Dr. Jessica Zdinak is an Eastern Shore of Virginia native who received a B.S. in Psychology from Christopher Newport University, and a M.S. and Ph.D. in Experimental Psychology & Statistics from Oklahoma State University. Dr. Zdinak has dedicated 20 years working as a behavioral scientist in a variety of settings, including academic, federal government, public health, and industry, and now serves as chief research officer of a leading US-based Contract Research Organization, ARAC.
Her team services both US and international clients in their product development and consumer research supporting innovation and “next generation” products, with a focused expertise on the regulatory sciences for US applications including: ITP, PMTA, MRTPA, SE, 510(k),and breakthrough designations.
The ARAC firm specializes in providing boutique-level personalized research services, combining their expertise in psychology, statistics, and behavior change, with a focus on the consumer, and the role of the regulator. Their triangular approach has proven successful across a variety of studies, including label development and comprehension, human factors/usability, clinical behavioral studies, specifically randomized experimental trials, TPPI, and post-market surveillance systems.
By Dr. Jessica Zdinak and Dr. Douglas Ming Deng
There is a noticeable separation between research and development (r&d) and compliance among leading RRP (reduced risk products) companies. It is no surprise that despite a marked increase in r&d investing, feedback for product improvement is lacking in direct consumer interaction. Engaging with actual smokers that are transitioning to RRP by addressing their concerns directly ensures a more holistic approach to increasing the efficacy of CNAS-assessed laboratories equipped with e-liquid lines that meet good manufacturing practice standards. Despite their technological sophistication and substantial investments in state-of-the-art labs, most companies still engage in expert-oriented r&d.
Typically, feedback for debugging and product improvement comes from dealers in the United States, rather than direct interaction with final product consumers, or smokers. Such a model has been effective, considering the limited target market. However, when considering the larger scope of smoke-free conception, which encompasses a large population of smokers transitioning to RRP, a sound methodology to engage with smokers and address their key concerns is essential for success.
PMTA module 6
Pre-market tobacco application (PMTA) module 6 is focused on large-scale population health impact. Despite potential complaints about PMTA authorization efficiency, it is undeniable that PMTA place consumers at the center of regulation. For some, PMTA may seem like a mandatory, costly process. However, those who recognize the business opportunity in module 6 stand to benefit significantly by transitioning from expert-oriented r&d to a more consumer-centric approach. Whether through outsourcing or implementing in-house studies, efforts to complete PMTA module 6 enables a deeper understanding of smokers which includes their behaviors, preferences, and, most importantly, how e-cigarettes can help them transition from combustible cigarettes to RRPs.
The acceptance by companies of the entire PMTA process, and specifically with focus to module 6 are imperative steps to market success. Historically, many nicotine or tobacco manufacturers may not have realized their businesses would rest greatly upon social scientists with credible degrees and expertise. Many of these companies had been conducting standard chemistry and toxicological studies well before the PMTA guidance, so these areas of the application were more well known and standardized. While some may have considered module 6 as the “black hole,” it has become clear that this section can “make or break” applications.
Module 6 & the PMTA process
The PMTA process typically begins with identifying a candidate product that proves worthy of expending millions of dollars in resources to get to market. This internal preliminary work can include pilot studies, qualitative research, and other indicators that validate the following:
- consumers want the product.
- consumers like the product.
- the product is likely to “pass” the standards set forth in each of the application modules.
It is important to keep in mind that the data generated from this study be able to both qualitatively and quantitatively describe and define the likelihood that potential consumers, and target audiences, will successfully use or misuse the candidate product.
Many companies will start with what are often considered “hard” sciences to ensure the candidate product is, for example, stable over time and has reduced harmful and potentially harmful constituents HPHC. Then, it is critical to plan and conduct the following module 6 studies:
- Human Factors/Usability Testing
- Label Comprehension
- Tobacco Product Perceptions & Intentions (TPPI)
- Experimental Switching Studies
What research questions are these studies asking, and why are they important?
Human factors/usability testing
For human factors/usability testing, the main questions revolve around the correct use of the candidate product to measure whether it is APPH (appropriate for the protection of public health). While not all-inclusive, this study answers the following questions:
- What is the likelihood that potential consumers will successfully use this product?
- What is the likelihood that potential consumers will misuse the product, as indicated by their product use?
These studies are vital because they assess consumer behavior to prevent misuse, impacting the APPH risk-benefit ratio. Misuse, such as using the wrong e-liquid or refilling incorrectly, increases the likelihood of harm. Collecting real-life data is crucial to avoid group biases and accurately assess potential real-world consumer behavior. The data must both qualitatively and quantitatively describe the likelihood of successful or unsuccessful product use.
Label comprehension
In label comprehension studies, the focus is to assess whether potential consumers comprehend and understand the proposed candidate product label, labeling, and marketing. Specifically, they answer the following questions:
- Do consumers understand the product instructions, as indicated by their intended or actual product use?
- Is it clear to potential consumers who this product is intended for?
- Is it clear what the product is and how much nicotine it contains?
TPPI studies
In TPPI studies, the primary purpose is to quantitatively assess both users’ and nonusers’ perceptions and intentions related to the candidate product, including packaging and labeling. This is one study that collects data on both the risks and benefits to the APPH standard, including both non-users, young adults, and current users. More than any other study in module 6, TPPI studies can be conducted using a variety of methods, including survey-based, random assignment survey-based, or in person large-scale focus groups, to name a few. This study provides FDA with an understanding of the potential for non-users to find the candidate product appealing which would add to the risk ratio. Behavioral intentions and risk perceptions are precursors to future behavior and have been found to be significant variables when predicting future behavior. Therefore, FDA gets a glimpse into the potential benefit of a candidate product to increase the desired behavior.
TPPI studies measure the following primary outcome variables:
Risk Perceptions
- Absolute risk perceptions and tobacco-related diseases, including nicotine addiction
- Risk perceptions of the candidate product relative to NRT, quitting smoking, and other tobacco products, including comparative products within and across tobacco product categories
Behavioral Intentions
- Intentions to try / use the candidate product
- Intentions to dual use with the candidate product and combustible cigarettes
- Intentions to switch from combustible cigarettes to the candidate product
Switching studies
To one of the most debatable discussions in the industry: what does it take to behaviorally demonstrate that smokers will switch to the candidate product above and beyond a reference or control group, with the specific consideration of the risks of marketing such product. In October of 2023, FDA held a workshop to outline their current thoughts on how to conduct such studies. While there are two major types of studies that fall under this umbrella: randomized controlled trials and longitudinal cohort studies, some manufacturers don’t understand exactly how to implement such studies. This is where it becomes critical that companies work with independent research organizations that hold both the industry knowledge and experience, as well as the academic expertise and credentials. To date, FDA has made it clear through MDO responses that a shortcoming of PMTA has been on the assessment of “benefit” to adult smokers.
Switching studies should measure the following outcome variables:
- Impact of candidate product on short-term & long-term switching and cessation
- 50%+ reduction in cigarettes per day (CPD)
- Cigarette cessation
- Candidate product use
Conclusion
Many manufacturers continue to struggle with implementation, emphasizing the need for collaboration with experienced research organizations with awareness of relevant FDA workshops. FDA has highlighted the importance of assessing the “benefit” to adult smokers in PMTA. Such research, known commonly as “switching studies,” should measure outcomes like the candidate product’s impact on short-term and long-term switching, cessation, and reduction in cigarettes per day. This comes down to human behavior.
There is nothing more complex and ever-changing than human behavior. To understand a person, their thoughts, their feelings, their behaviors, is one of the greatest challenges of our time, particularly when it comes to a chemical that is very addictive and influences human behavior differently, depending on the individual. If we want to contribute to the betterment of public health and humankind, then we need to address the various regulators’ guidance and concerns. In the ongoing industry debate, the focus is on demonstrating smokers’ behavioral shift to the candidate product while considering marketing risks.