Government health authorities’ perspectives on heated tobacco products

Health authorities around the world have begun to examine the evidence showing the potential role of smoke-free products in their harm reduction strategies if they have one. Here is an overview of government publications which touch on our Tobacco Heating System (THS) specifically, or on heated tobacco products (HTPs) in general. Note that there may be some overlap between this list and the independent studies with original data or analysis on THS.

 

U.S. Food and Drug Administration (FDA)

The agency announced in 2017 a comprehensive plan for tobacco and nicotine products, with the goal of “striking an appropriate balance between regulation and encouraging the development of innovative tobacco products that may be less dangerous than cigarettes.”

In July 2020, the agency granted modified risk orders with reduced exposure information for Philip Morris International’s IQOS system, a heated tobacco product and the first electronic nicotine-containing product to receive such orders. This was the second set of products to receive market orders under the MRTP pathway. FDA issued this exposure reduction order and acknowledged that a reduction in risk is reasonably likely to be demonstrated in future studies.

According to the FDA’s press release: “In particular, the agency determined the company demonstrated that because the IQOS Tobacco Heating System heats tobacco and does not burn it, it significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke. Furthermore, studies showed switching completely from combusted cigarettes to the IQOS Tobacco Heating System significantly reduces the body’s exposure to 15 specific harmful and potentially harmful chemicals.”

 

Public Health England (PHE)

PHE, an executive agency of the UK’s Department of Health and Social Care, releases a regular report on the evidence behind cigarette alternatives. For the first time, the fourth such review published in February 2018 included information on heated tobacco products. They summarized their key findings on heated tobacco products—primarily IQOS by Philip Morris International, ‘glo’ by British American Tobacco, and ‘Ploom TECH’ by Japan Tobacco International, with most studies focusing on IQOS. The agency found that ”Compared with cigarette smoke, heated tobacco products are likely to expose users and bystanders to lower levels of particulate matter and harmful and potentially harmful compounds. The extent of the reduction found varies between studies.” They also placed heated tobacco products on the continuum of risk, saying “The available evidence suggests that heated tobacco products may be considerably less harmful than tobacco cigarettes and more harmful than e-cigarettes.”

 

UK Committee on Toxicity (UK COT)

The UK COT is an independent scientific committee that provides advice to the Food Standard Agency, the Department of Health, and other government departments and agencies on matters concerning toxicity of chemicals. The agency reviewed the available evidence on two heated tobacco products: IQOS by Philip Morris International, and iFUSE by British American Tobacco. The assessment concluded that, while still harmful to health, heated tobacco products are likely to be less risky than smoking conventional cigarettes. UK COT also stated that “There would likely be a reduction in risk for conventional smokers deciding to use heat-not-burn tobacco products instead of smoking cigarettes.”

 

German Federal Institute for Risk Assessment (BfR)

BfR is a branch of the Federal Ministry for Food and Agriculture and is responsible for the assessment of issues related to consumer protection. BfR has analyzed the aerosol of IQOS tobacco heating system and found reductions in selected toxicants (80%-99%) compared to cigarette smoke. This research, published in 2018, was in line with the manufacturer’s (Philip Morris International’s) already-published data. The study states that while further studies are required to address the magnitude of exposure reduction, the measured reductions “lead to the relevant questions of putatively reduced health risks.”

 

National Institute for Public Health and the Environment (RIVM)

RIVM is an agency of the Dutch Ministry of Health, Welfare, and Sport. In 2018, it published a preliminary assessment of IQOS in a factsheet that summarized its own research as well as that of the current scientific knowledge at the time. The institute found that it is not possible to light a tobacco stick and smoke it, and that the emissions when heating are different than burning tobacco because the substances formed depend on temperature. RIVM concluded that "The use of heatsticks with the IQOS is harmful to health, but probably less harmful than smoking tobacco cigarettes," based on its aerosol chemistry measurements, which are "of the same order of magnitude as in the data of Philip Morris."

A more recent publication by Slob et al. from RIVM described the development of a methodology to estimate risk for heated tobacco products relative to cigarettes. The authors concluded that “The CCE—change in cumulative exposure—was estimated to be 10- to 25-fold lower when using HTPs instead of cigarettes. Such a change indicates a substantially smaller reduction in expected life span, based on available dose-response information in smokers. However, this is a preliminary conclusion, as only eight carcinogens were considered so far.” The work by Slob et al. was funded by the Netherlands Food and Consumer Product Safety Authority (NVWA), Utrecht, The Netherlands.

 

Belgium

In April 2020, the Superior Council of Health in Belgium (Conseil Supérieur de la Santé – CSS) provided a scientific advisory report on the toxicity and safety of heated tobacco products. The Belgian health authorities—although adopting a precautionary approach and highlighting the need for additional long-term research—confirmed that the in vitro and in vivo studies show reduced exposure to harmful products and, subsequently, reduced subchronic toxicity after exposure to heated tobacco products relative to conventional cigarettes. Moreover, the report acknowledged that: “In clinical studies, after switching from conventional cigarettes to heated tobacco products (IQOS or GLO), there has been a significant decrease in the concentrations of biomarkers of exposure to harmful and potentially harmful compounds, although they are not considered to be completely safe. Favorable changes have also been noted in some biomarkers of biological impact, which suggests that there is a potential for a reduced risk of disease in the event of giving up conventional tobacco in favor of products based on heated tobacco."

 

Japanese Department of Environmental Health

This department is a branch of the Japanese National Institute of Public Health, which has conducted a study comparing the levels of chemicals in IQOS aerosol and cigarette smoke. The authors of the study concluded that “The concentration levels of hazardous compounds in the mainstream smoke of IQOS are much lower than those in conventional combustion cigarettes.”

 

Korean Ministry of Food and Drug Safety

Korean Ministry of Food and Drug Safety (MFDS) issued a statement on products that heat rather than burn tobacco, based on measurements performed in its own laboratories of three heat-not-burn (HNB), products including IQOS. It measured the 9 Harmful and Potentially Harmful Constituents (HPHCs) defined by the WHO as a priority list for mandatory reduction, as well as nicotine and “tar”. 

MFDS results confirm significant reductions of HPHCs in HNB products compared to cigarettes – but omit to discuss them. In its discussion, MFDS mentions that HNB products also contain carcinogens, like benzopyrene and benzene. What it fails to mention is that the levels measured are more than 10 times lower compared to the levels present in cigarette smoke. In fact, their own data show that these 2 carcinogens are reduced by more than 95% (for benzopyrene) and more than 99% (for benzene) when comparing the levels of HNB products to the top 5 most sold cigarette brands in Korea. When considering the 9 measured HPHCs, the average reduction of HNB products compared to Korean cigarettes (top 5 most sold brands) is more than 90%.

On nicotine, MFDS commented that nicotine in HNB products is similar to cigarettes, which is absolutely correct and intended as HNB products are meant to be a better alternative for smokers who would otherwise continue to smoke. In this context, product acceptance by adult smokers is essential. And to maximize product acceptance, the levels of nicotine should mimic cigarettes as closely as possible.

The MFDS also uses “tar” to compare products, an approach that is misleading because it gives no indication on the content of the HPHCs of the products. “Tar” is the total weight of solid and liquid residue in cigarette smoke after the weight of nicotine and water has been subtracted. However, it fails to give any indication about the composition of the smoke or aerosol, and in particular the amount of HPHCs. Many governments and public health organizations have supported removing “tar” measurements as being misleading to consumers. Beyond this, the aerosol of a smoke-free product is significantly different compared to the smoke of a cigarette. Thus, any comparison of cigarette “tar” and the weight of aerosol/vapor produced by products that do not combust is therefore a deception and misleading, as the comparison is done between the weights of 2 mixtures with very different compositions and toxicities.

Our public comment on the MFDS (formerly KFDA) statement is available.