What scientific evidence is considered when evaluating product regulation?

In a world reeling from the Covid-19 pandemic, the role of science has been brought into sharp focus. Chief scientific advisers, epidemiologists and infectious disease experts have become household names around the world. All hopes pinned on pioneers of modern medicine to provide the escape route: a vaccine. We are guzzling up information with newfound gusto, hungry for the facts of science over the disorientation of hearsay, rumour and rhetoric.

Yet, this spotlight doesn’t extend to the wider context and opportunities built on the foundations of scientific understanding to advance humanity are being missed. When science is not leveraged to its full potential — when the public and government officials are denied access to accurate and easy-to-understand scientific information — a gap is created that allows ideology, politics and unsubstantiated beliefs to take precedence over facts. This impedes progress.

The recent Philip Morris International white paper, In Support of the Primacy of Science, revealed 77% of people polled across 19 countries, including SA, are hopeful that advances in science will solve many of the world’s most pressing problems.

With more than one-billion smokers in the world today, and 11-million in SA, smoking-related diseases are among these pressing problems. How can science help? 

While tobacco control measures aimed at preventing smoking initiation and encouraging cessation are in place, there is growing consensus that more can be done to decrease smoking and that tobacco harm reduction (THR) can complement these measures. THR involves strategies to provide adults who would otherwise continue smoking with access to accurate information about less harmful alternatives. 

The scientific evidence shows nicotine, while addictive and not risk-free, is not the primary cause of smoking-related diseases. Rather they are caused by the harmful chemicals present in smoke which is produced when burning tobacco. Through science and technology, nicotine delivery has been decoupled from burning tobacco to create smoke-free products such as heated tobacco products, e-cigarettes and other innovations, which can reduce the formation of harmful chemicals and the body’s exposure to these toxicants compared to cigarette smoke. 

To be clear, these products are not risk-free and contain nicotine, which is addictive. The best choice any smoker can make is to quit tobacco and nicotine altogether. However, most don’t. Changing to scientifically substantiated smoke-free products is a better choice than continued smoking and can represent a public health opportunity to accelerate the decline in smoking prevalence and smoking-related population harm.

But this can’t happen if adults who smoke are unable to get accurate information about or access to these products. 

According to the white paper, while 87% of SA respondents seek more in-depth, reliable information about scientific developments, only 18% find it easy to access the latest scientific developments and studies. In the case of smoke-free products, reliable information is perhaps tougher to come by given the barrage of misinformation spread by those ideologically opposed to the idea that adult smokers should have access to better alternatives. 

This behaviour and misinformation must be challenged because it perpetuates cigarette smoking, which is the most harmful form of nicotine consumption. 

According to the white paper, 84% of people polled across all countries want their governments to take recent findings into account when crafting policy. However, just 51% of those people believe their leaders are doing so. Just over half (54%) believe that their government does a good job of communicating unbiased and reliable information about the latest scientific developments and studies. 

This implies that beyond looking for objective facts and assessing the totality of available evidence to inform their decisions, it’s equally important for policymakers to debate the data openly and transparently. When policymakers are guided by robust science, it is in their interests to provide access to science content that explains and justifies their policy decisions.

Regulatory frameworks that put science and evidence at the heart of decision-making and differentiate smoke-free alternatives from combustible cigarettes to promote public health already exist. For instance, the US Food and Drug Administration modified risk tobacco product application process sets a clear pathway for the assessment and potential authorisation of claims relating to tobacco and nicotine-containing products that are scientifically substantiated to be a better choice than cigarettes for adults who would otherwise continue to smoke. 

Scientifically substantiated smoke-free products represent a public health opportunity. Regulating these products differently to cigarettes will ensure adult smokers know about them, and can get reliable information about them, to make better choices than continued smoking.

The scientific evidence regarding smoke-free products should be trusted to inform regulations that encourage adults who would otherwise continue smoking cigarettes to choose better alternatives. However, in SA all tobacco products are regulated in the same way as cigarettes, despite some being fundamentally different, which raises an important question: What scientific evidence is being considered or reviewed when evaluating how these products should be regulated?

This article was paid for by Philip Morris.