The US FDA states that heat-not-burn tobacco greatly reduces exposure to harmful substances compared to cigarette smoking. At the same time, the agency continues to put the brakes on large parts of the vejp product market. The result is a rapidly growing conflict over which nicotine products can actually be called less harmful.
The US FDA confirms that heat-not-burn technology dramatically reduces the risks of nicotine use compared to smoking.
“Scientific studies have shown that a complete switch from regular cigarettes to the IQOS system significantly reduces the body's exposure to harmful or potentially harmful chemicals,” writes FDA in a statement.
”Rigorous scientific basis”
IQOS, which is one of several variants of heat-not-burn, is manufactured by Philip Morris International (Swedish Match in Sweden) and is currently the only vejp-related product that can be marketed as “harm reduction” in the United States. The classification, which also includes General snus, was introduced in 2020 and is based on studies developed by the manufacturer and reviewed by the FDA.
“As the only company to successfully obtain and maintain such an approval for heated tobacco products in the U.S., we are confident that our science-based alternatives can help adult smokers transition from cigarettes to smokeless alternatives,” said Stacey Kennedy, Managing Director of PMI in the US. “This decision reflects both the rigorous scientific basis supporting IQOS and our continued commitment to providing smoke-free alternatives.”
Smoke-free rush - but uneven playing field
The market for nicotine products in the US is in the midst of a rapid transition. According to several economic forecasts, smokeless alternatives are expected to overtake cigarette sales soon. The drivers are e-cigarettes and white snus - but heat-not-burn is also growing, albeit from lower levels.
At the same time, patent disputes have slowed down the widespread roll-out of IQOS in the United States. Elsewhere, progress has been faster.
Stronger in Europe and Asia
In Japan and parts of southern and eastern Europe, heat-not-burn has had a much greater impact. In Japan, where nicotine-containing e-cigarettes are not authorised, IQOS and Heets account for almost half of PMI sales.
Since its launch 10 years ago, technology has evolved significantly. Today's models increasingly resemble rechargeable e-cigarettes, both in form and function. In Sweden, for example, the model IQOS Iluma which uses induction heating instead of the previous hot plate technology. Much of the production for the EU market takes place in Switzerland and in Bologna, Italy.
Millions in claims stop smaller operators
At the same time as heat-not-burn is being recognised as “public health justified” in the US, it has proved much more difficult for traditional vejp products to pass through the same regulatory eye of the needle.
A key factor is cost. In order to even get their products tested, manufacturers have to produce an extensive scientific dossier - a process that can cost up to 10 million SEK per product.
Unlike the EU's category-based regulatory framework, the US system is based on individual product authorisations. As a result, more than nine million applications have been submitted, but only around 30 products have been authorised so far.
Most of these come from big tobacco companies - and are sold exclusively with artificial tobacco flavours.
Grey market dominates
Critics argue that the regulations in practically wiped out smaller manufacturers and greatly reduced the diversity of the market. At the same time, a large grey and black market has emerged.
Today, up to 95 per cent of e-cigarette sales in the US are estimated take place outside the regulated system, where Chinese manufacturers dominate with various disposable models.
Facts: What is Heat-Not-Burn?
Heat-not-burn (HNB) is a technology where tobacco is heated instead of burnt. In practice, the systems work as a hybrid between traditional smoking and e-cigarettes.
Unlike regular vapes, HNB products actually contain tobacco, which in combination with an e-liquid (glycerine) generates an aerosol when heated. The temperature is lower than during combustion, which reduces the formation of many harmful substances.
Research, including by UK public health authorities, shows that exposure to harmful substances is significantly lower than from cigarette smoking.
Not without risk - and higher levels than vapes
At the same time, the risk level for HNB is higher than for traditional e-cigarettes. This is partly due to the tobacco content and partly due to higher temperatures.
HNB heats the glycerine mixture to around 400 degrees. Regular e-cigarettes operate at lower temperatures (up to around 300 degrees) and contain no tobacco, resulting in lower levels of potentially harmful substances in the vapour.
However, the difference compared to cigarette smoke is significant in both cases - emissions are at a fraction of the levels from combustion, according to both US and UK authorities.
Traditional e-cigarettes (and e-liquid) entered the market in 2002. The first Heat-not-Burn product came out in 2015.
