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Businesses that lead product innovation with what the consumer wants will be one step ahead when it comes to taking a next-generation product to market – particularly when making premarket tobacco product applications (PMTAs) in the US.
That is the view of founder and chief research officer (CRO) of Applied Research and Analysis Company (ARAC) Jessica Zdinak (pictured), who will be speaking about successful innovation in next-generation products at at the Intertabac trade fair for tobacco products and smoking accessories in Germany from 19th to 21st September.
ARAC’s expertise is in product development and consumer research supporting innovation and next-generation products, with focused expertise on regulatory behavioural science research for US applications, such as switching studies, human factors/usability studies, and tobacco product perception and intention (TPPI) studies.
Although Zdinak’s “equation for success in next-gen products” might sound counter-intuitive at first, she told TobaccoIntelligence that exploring consumers’ requirements, while considering the product’s feasibility to meet the various scientific standards, as well as the regulatory environment, would avoid wasting time and money developing a product that might ultimately fail because it’s not what consumers want.
“It’s not about launching the product to find out what consumers want,” she said, “it’s about exploring the characteristics of various products through concept testing and leveraging in-depth research methodologies to get to know the audience.”
Adapting to regulatory shifts
One hypothetical scenario might be if regulators ever restricted the use of pouches in Sweden. In this (somewhat unlikely) instance, companies that have explored what Swedish consumers need and want from inhalers, or other novel nicotine delivery systems, would have the knowledge to be first to market with an alternative product that would tick the right boxes to fill the gap.
Governments frequently turn over, so regulation is prone to change.
For example, a ban on the sale of disposables will come into force in the UK in April 2025. When it does, some consumers will respond by reverting to smoking while others will switch to non-disposable hardware. Zdinak’s research indicates that many consumers – particularly those who are older – dislike having to navigate a device kit with a lot of technology. Therefore, companies that can give disposable consumers a product that fulfils the same needs for convenience and ease of use will be ahead of the game.
Disposables might offer convenience, but they might not offer heavy smokers the same nicotine levels and satisfaction that a cigarette provides. This can make them less successful as smoking cessation tools, according to Zdinak.
“It’s this dichotomy we see, because in a lot of our studies, it’s the e-liquids with potentially higher nicotine levels that are the most effective at switching smokers,” she explained, “because they’re giving them the nicotine level and satisfaction I believe they need.”
Zdinak believes the way to stop disposable consumers from reverting to smoking when the ban comes in is to provide a product that offers some of the convenience and instant satisfaction of a disposable but with nicotine levels similar to those of a cigarette. She says this is because “smokers have been used to the convenience of lighting a cigarette and then the instant gratification of nicotine satisfaction for their whole lives”.
Dealing with the lengthy PMTA process
Zdinak says she never got to meet her grandfather because he was a two- to three-pack-a-day Marlboro Red smoker and cites this as part of the reason why she is so passionate about harm reduction. She founded ARAC after working as lead principal scientist for Altria, where she collaborated with the US Food and Drug Administration (FDA) to provide data for PMTAs.
Meeting the standards required for the US FDA’s PMTAs is a lengthy process that involves an expensive amount of science and data gathering. This can take years, by which time the product’s technology could be out of date and consumers will have moved onto something new.
Zdinak believes the way to overcome this challenge is by fostering partnerships and close collaborations with regulatory experts and scientists as early as possible. Bringing different perspectives together will help to expedite the product’s path to market before it becomes stale.
Zdinak believes many authorised products on the market are out of date because the current PMTA application process takes so long that some standards have changed, or are prohibitively high. Plus, many new product innovations are not being launched because the process is so off-putting. Instead, the market is being flooded with illegal products made by companies who have no intention of submitting regulatory applications because enforcement has not been as strong as it should be.
The issue of risk is also hindering product innovation.
“There’s a myth that if a product receives authorisation within whatever regulatory pathway, that it’s safe,” said Zdinak. “I know the FDA is really concerned that authorising a product makes them liable. But the reality is that the right product could protect public health and could have a lower risk profile than cigarettes.”
Reducing youth vaping
Zdinak believes the biggest win for the industry in future would be being able to reduce youth vaping.
While age-gating products and ensuring packaging is appropriate is a challenge in itself, education is key to deterring youth use – both from parents and schools.
“Successful products will need to have to have some type of preventive, education mechanism, or significant post-market surveillance that ensures young people are not increasing their use of the product,” said Zdinak.
Industry transparency
She advocates a stronger commitment to transparency from the industry, while acknowledging that it’s hard for companies to outline the risks and benefits of their product because the industry, manufacturers and sponsors are restricted in what they can say to the consumers and the public. This is a particular issue if companies are developing products via regulatory pathways. For example, if a company is making a PMTA in the US, the FDA doesn’t allow it to communicate with consumers about the potential reduced risk or exposure, unless authorised through the modified risk tobacco product application (MRTPA) pathway.
“There’s a gap between what they really want to do – which is improve public health – versus what you see in the media and in real life, which is a very real concern. How can companies be transparent if they believe they will be stabbed in the back through public comment, political action, or with a marketing or authorisation denial?” she asked.
“And on the FDA side, they’re thinking: how can I be transparent to the industry without getting sued?” she added. “So, they’re both in separate corners, and it’s really sad that companies are developing products and conducting good science without having a good relationship with the regulator. On the flip side, I understand why the regulator doesn’t respond to them, because then they just get sued by the sponsor.”
Zdinak called for an independent third-party advocacy group that could step in to bridge this gap, “because there is going to be no benefit to public health if we do not authorise reduced harm products onto the market quickly. And the only way that’s going to get done is if people talk to each other”.
Jessica Zdinak will be speaking about successful innovation in next-generation products at Intertabac in Germany from 19th to 21st September.
– TobaccoIntelligence staff
