LATEST ALERTS
The US Food and Drug Administration (FDA) process for quantifying the risk of under-age use of next-generation products (NGPs) is being overestimated to the degree that it is fuelling the illicit market because so many NGPs are being refused authorisation.
That is the view of the behavioural epidemiologist Andrea Patton (pictured), who is head of prevalence research at the Centre for Substance Use Research (CSUR) in the UK and leader of the Tobacco Product Prevalence Study (TPPS), which estimates the prevalence of under-age use of tobacco and nicotine products in the US.
Patton – who will be speaking about tackling illicit vapes and youth vaping at the upcoming World Vape Show in Dubai – told ECigIntelligence that, when processing premarket tobacco product applications (PMTAs) for NGPs, the FDA assesses the danger of them being adopted by unintended users by quantifying the risk of the entire brand, rather than individual tobacco products.
“Why is the risk of a product being held up against the risk of an entire category?” she questioned. “We’ve seen the US FDA attempting to create a regulated market, but in reality, it is creating an illicit market in that the majority of NGPs now available for sale in the US are not authorised.”
She warned NGP manufacturers considering submitting PMTAs that the US FDA puts the onus for evidence on the applicants. This means they need to provide evidence to demonstrate the benefit of their products to adults (21+) who are smoking, as well as evidence to quantify the risk of it being adopted by unintended user populations – such as those who are under-age (under-21s).
If manufacturers do not submit their own risk quantifications as evidence, the FDA will rely on its own data, which is taken from national surveys with broad estimations as opposed to specific estimates for individual products.
“If you’re assessing the risk of an individual flavoured disposable e-cigarette, for example,” said Patton, “quantifying the risk as the number of under-age people using all flavoured e-cigarettes would clearly be an overestimation of the risk of the individual product. Market denial orders state that around 90% of the kids currently using e-cigarettes are using a flavoured product, but for an individual product, the numbers beneath the percentages are lower: in the tens of thousands.”
Finding ways to help older adults quit smoking
The CSUR wants to see more US FDA market authorisations for NGPs, and for that to happen the evidence needs to prove that the health benefits of the products to adults who smoke outweigh the risk of their adoption by under-age users.
Patton called on manufacturers to build more age-gating technology into devices to prevent under-age use, such as pairing devices with mobile phones, face-recognition technology, point-of-sale ID and so on. She highlighted the fact that the FDA would prioritise such products for review.
“Tobacco use is one of the leading causes of preventable death across the world, so we need to make more reviewed regulated products available and remove the likelihood of youth use,” she said.
Targeting older smokers remains a challenge. The CSUR’s TPPS indicates that e-cig use among adults who are currently smoking tends to be centred around those under 45. And the prevalence of ever use (“Have you ever tried an e-cigarette, even once or twice?”) in adults age 45 and older who also currently smoke is low.
Patton stresses the importance of older adults’ first encounter with a device being a positive one and advises the industry to research and cater for the preferences of this demographic.
“Adults who are smoking and aged 45-plus are the people most at risk of harm. They have smoked for longer and may not want or be able to stop, so it’s important to find out which method will convince them to do so. It’s about having the full repertoire of reduced-risk products available and offering a wider range of options.”
The stigma associated with nicotine
She called for more research into the preferences of older smokers and what the barriers to their take-up might be.
“Is it just their perception of the product as not safe? Or is it the nature of the product? For example, when the tanks first came out, they generated a plume of smoke like a steam train, which might be obtrusive and unappealing to consumers who might prefer having a tiny device, which they can discreetly hold in their hand. It’s not just about product design, it’s about considering perceptions, preferences and awareness.”
Patton cited countries that are seeing reductions in smoking prevalence as examples of success by tailoring products to the social and cultural aspects of a particular area. Sweden, for example, reduced its smoking rates via oral nicotine products, while Japanese consumers have shown a preference for heated tobacco products.
She also called for more education aimed at disentangling the conflation of nicotine with tobacco and its association with combustible cigarettes – for physicians and healthcare providers as well as consumers.
“People think nicotine is carcinogenic, but it’s all about the vehicle you use to consume it,” she said. “Nicotine is a stimulant with a similar composition to caffeine and can even be used recreationally in the same way. Having a coffee is considered trendy and cool, but nicotine is still considered to be a bit of a demon. But it has benefits, such as improved concentration and performance enhancement.
“We may get to a point where nicotine can be consumed in a similar way to caffeine, but we’re not there yet. How can we convince people to move to reduced-risk products when they consider nicotine to be the harmful component?”
The ‘volatile’ regulatory scene makes it hard to keep up
Innovation and education aside, the industry is also battling with the world’s “fragmented, slow and dysfunctional” regulatory systems.
“Country, environment and cultural context play an important part in product design, but the political and regulatory scene is so volatile, it’s confusing and hard for product innovators to keep up,” said Patton.
“For example, the US FDA has authorised Zyn nicotine pouches, but has clearly stated in its market authorisation documentation that this authorisation could be reversed if the under-age use of pouches increased. Meanwhile, in Europe, Spain is attempting to ban flavoured nicotine pouches, but Sweden is trying to intervene on this decision, as its government perceives it to be a threat to harm reduction.”
Patton is hopeful that further evidence coming from studies and bodies such as the Cochrane Collaborative will strengthen the evidence on the efficacy of NGPs in the future. However, in the meantime, in the US, all the industry can do is process its PMTAs as directed by the FDA.
- Andrea Patton will be speaking about tackling illicit vapes and youth vaping at the upcoming World Vape Show in Dubai next month.
- Also at the World Vape Show, visit the Tamarind Intelligence booth, number 8017, and hear our legal analysis director, Pablo Cano Trilla, present “What lies ahead for the tobacco alternatives sector? Key legal and political challenges and opportunities”.
– ECigIntelligence staff
