A new way of thinking

No doubt, many have started to embrace and patronize alternatives to conventional tobacco products such as cigarettes, obviously for health reasons.

Unlike cigarettes which are burned and subject to combustion, so-called heated tobacco products or HTPs are not burned, but heated so that the tobacco leaves still release flavors and nicotine.

Because they are not heated, HTPs are generally smoke-free and do not produce tar, which is the one that damages the lungs of smokers. Tar is said to contain most of the cancer-causing and other harmful chemicals found in tobacco smoke. When tobacco is inhaled, the tar forms a sticky layer on the inside of the lungs and damages the organ, causing diseases like lung cancer, emphysema, chronic obstructive pulmonary disease (COPD) and other lung diseases.

The most ideal situation of course for smokers is to simply stop smoking, whether it be cigarettes, HTPs, electronic nicotine delivery systems like vapes and other non-combustible tobacco products. But then this is easier said than done. For those who cannot quit smoking that abruptly, they find that switching to alternatives helps.

The scientific world is already awash with studies to show that the use of tobacco alternatives is safer and reduces the risk, if not completely eliminating it.

It is for this reason that the US Food and Drug Administration just last July 7 authorized the marketing of IQOS, an electronically heated tobacco system produced by Philip Morris International (PMI) as a modified risk tobacco product (MRTP). This marks the second set of products ever to be authorized by the US FDA as MRTP and the first innovative electronic tobacco product to receive “exposure modification” orders from the agency.

Exposure modification orders permit the marketing of a product as containing a reduced level of, or presenting a reduced exposure to a substance, or as being free of a substance. The issuance of the order is expected to benefit the health of the population.

In particular, the USFDA determined that Philip Morris Products S.A. 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 have shown that switching completely from combusted cigarettes to the IQOS system significantly reduces the body’s exposure to 15 specific harmful and potentially harmful chemicals. The toxicological assessment also found that, compared with cigarette smoke, IQOS aerosols contain considerably lower levels of potential carcinogens and toxic chemicals that can harm the respiratory or reproductive systems.

According to PMI chief executive officer André Calantzopoulos, the US FDA’s decision demonstrates that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking.

He said the US FDA decision is a historic public health milestone. “Many of the tens of millions of American men and women who smoke today will quit, but many won’t. The decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke,” he pointed out.

For his part, US FDA Center for Tobacco Products director Mitch Zeller, J.D. explained that through the modified risk tobacco product application process, the agency aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable.

He noted that the evidence submitted by [Philip Morris] shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.

The authorization for IQOS products also requires Philip Morris to conduct post-market surveillance and studies to determine whether the MRTP orders continue to be appropriate, including assessing the potential for increased use among  the youth.

The IQOS tobacco heating system includes the electronic IQOS device that generates a nicotine-containing aerosol by heating tobacco-filled sticks wrapped in paper. The US FDA previously authorized the marketing of these products without modified risk information in April 2019 via the pre-market tobacco application (PMTA) pathway.

According to the US FDA, the IQOS system heats tobacco, but does not burn it. “This significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals,” it said.

Given all these then, what the World Health Organization (WHO) said in its recent information sheet on its website that “currently there is no evidence to demonstrate that HTPs are less harmful than conventional tobacco products and to suggest that reduced exposure to these chemicals translates to reduced risk in humans, and that additional independent studies will be required to substantiate claims of reduced risk/harm,” is misleading if not entirely wrong.

The US FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to protect and promote public health.

It is high time that our local health officials and legislators take an objective look at the emerging evidence for tobacco harm reduction and break free from the WHO’s shortsighted “quit or die” stand on smoking.

In coming up with a regulations for reduced-harm nicotine products such as HTPs and e-cigarettes, governments should stop treating these products the same way that they treat conventional tobacco products since they are not the same in terms of risks to the health of its users. Simple examples: Why should users of these alternatives be placed in the same smoking room as users of cigarettes? Shouldn’t one have a better tax treatment than the other? In banning smoking to prevent harm to non-smokers, why include users of HTPs and e-cigarettes when the products that they use do not produce harmful smoke? The list goes on and on.

For comments, e-mail at [email protected]