LATEST ALERTS
The recent nomination of Robert F Kennedy Jr., a prominent environmentalist and vaccine sceptic, as US secretary of health under president Donald Trump could have indirect implications for the nicotine alternatives industry, even in Europe.
Kennedy’s potential Senate confirmation suggests a possible reduction in federal agency involvement in nicotine product regulation. This could ease bureaucratic hurdles for companies by reducing the need to navigate complex approval processes. However, it could also slow innovation. While agencies like the US Food and Drug Administration (FDA) are often perceived as trailing market trends by years and are primarily focused on public health impacts rather than product development, they nonetheless influence innovation indirectly.
The need to stay ahead of FDA-recommended changes or comply with evolving safety guidelines often prompts manufacturers to invest in new technologies and research. For example, companies may develop cleaner formulations, safer delivery mechanisms, or more robust product testing protocols to meet evolving regulatory standards. Without the FDA’s oversight and research-driven guidance, companies may lose a significant driver for safe advancements. Conversely, regulatory relaxation might encourage bolder product experimentation, with innovations potentially gaining traction both in the US and eventually Europe.
Kennedy’s historical scepticism toward government health agencies suggests his leadership might lead to reduced emphasis on regulatory enforcement and possibly a shift in the FDA’s role from stringent oversight to more advisory functions. This potential shift aligns with Trump’s deregulatory agenda, creating further uncertainty that could also influence how regulations are handled in Europe. As the US regulatory landscape becomes more permissive, Europe seems to be moving in the opposite direction.
Regulatory pressure in Europe fuels tobacco-free innovation
In Europe, the ban on flavoured heated tobacco products (HTPs) – established under the second revision of the European Union’s Tobacco Products Directive (TPD2) – has been in effect for some time, prompting consumers to explore alternative products. This shift has driven the launch of herbal heated products by major tobacco companies, including Levia by Philip Morris International (PMI), Veo by British American Tobacco (BAT) and iSenzia by Imperial Brands.
According to 2023 data from TobaccoIntelligence, around 35% of heated tobacco users considered tobacco-free herbal heated sticks as a viable replacement for traditional heated tobacco sticks. Despite this interest, none of the top-ranked stock-keeping units (SKUs) in offline retailers that year were herbal heated sticks, as major brands had yet to launch them.
By 2024, however, 3% of the top reported SKUs were non-tobacco herbal heated sticks. This figure signalled a modest market presence, as companies introduced these products to maintain flavoured offerings despite regulatory constraints. The recent legal opinion by the advocate general of the Court of Justice of the European Union (CJEU) further reinforces this stance. While the final ruling is still pending, the advocate general’s opinion suggests that the ban on flavoured HTPs is likely to remain in place, unless the CJEU declares it invalid.
Should the CJEU ruling ultimately strike down the ban, it would allow the return of flavours to the market, which could have a significant impact. However, even in that scenario, the European Commission is expected to continue pushing for flavour restrictions in HTPs in the upcoming third revision of the TPD (TPD3).
If the ban remains intact, as is currently the case, the EU could see a continued shift in consumer preferences toward alternative products like nicotine pouches and vape products, which offer a wider variety of flavours. But this market shift could be temporary, as EU regulators might adopt even stricter rules across all nicotine products in the future.
While a ruling by the CJEU declaring the ban void may seem less impactful in the short term, it could accelerate the revision process of the TPD, driving a greater sense of urgency to regulate flavours in HTPs. If flavours are once again permitted in HTPs, the European Parliament would have a say on the European Commission’s proposal to potentially reinstate the ban as part of TPD3’s revision. This could lead to further fragmentation of the European market, with varying flavour regulations across countries, which could create a complex and competitive environment for companies operating in the region.
US players may eye European market
Another aspect to consider is the influence of FDA regulation on the speed of nicotine product approvals. Despite promises of reform, it is unlikely that such changes will significantly accelerate approval times for new products, such as the premarket tobacco product applications (PMTAs). These delays in US product authorisations could reduce the appeal of the US market for new companies, pushing them to focus on European markets – where regulation might be more fluid, even though it is also continually evolving.
Additionally, the suspension of communications by US health agencies, including the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), has had a direct impact on the transparency of information regarding alternative nicotine products. A similar scenario in Europe could limit public access to crucial scientific data, slowing progress in research on the effects of vaping and tobacco alternatives. Although the European Union is not subject to such a communication freeze, the blockage of health-related information in the US could reduce international cooperation and indirectly affect European policies, as US-generated scientific data is often used to guide health policies in Europe.
The growing friction between the US and the European Union could lead to a further isolation of European policies from those in the US. While the US might favour a more permissive approach or roll back certain restrictive regulations, Europe could follow a more cautious path, maintaining strict rules to protect consumers and public health. However, if the US adopts a more permissive stance, European companies might face competition from new US players in the European market, prompting European regulators to intensify efforts in safeguarding local policies.
– Antonia Di Lorenzo TobaccoIntelligence staff
Image: AI-generated
