SPAIN || PUBLIC CONSULTATION ON HEALTH MEASURES AGAINST SMOKING

Draft Law for the modification of Law 28/2005 on health measures against smoking and regulating the sale, supply, consumption and advertising of tobacco products

Attention of: Ministry of Health, Spain

As stated in the association’s previous communication during the Spanish consultation on flavours ban on April 2024, SCOHRE is following with great interest the initiatives that the Spanish Ministry of Health is taking to reduce smoking in Spain, and we would like to contribute to the public consultation for the “Comprehensive Tobacco Prevention Plan 2024-2027”. In view of the new legislation with the aim to further reduce the smoking rates, we would like to bring the following to your attention.

SCOHRE is an International scientific Association of independent experts on Smoking Control & Harm Reduction, who seek an open and constructive dialogue to help come up with a new approach to smoking control policies. We believe that smoking cessation and smoking prevention is the primary goal of our societies, and that the adoption of harm reduction policies may be considered as the 3rd pillar for tobacco control together with smoking cessation and smoking prevention to secure to a healthier future particularly for the younger generations.

Despite all efforts for the implementation of the Framework Convention on Tobacco Control (FCTC), smoking is still a major public health issue; the number of smokers exceeds 1 billion; we count more than 8 million premature deaths every year from smoking-related diseases; the number of smokers is growing.

SCOHRE supports the efforts worldwide to protect the young people, the non-smokers and the ex-smokers from any new forms of tobacco/nicotine consumption. Additionally, we fully support any effort to regulate nicotine-free e-cigarettes and herbal smoking products. However, in an era of technological innovation, new approaches continuously emerge based on less risky alternatives than cigarettes. For those smokers who for various reasons will not otherwise give up smoking completely, switching to less harmful products will have a tremendously positive effect. Novel tobacco products and Nicotine Delivery Systems such as electronic cigarettes, heated tobacco products and nicotine pouches could be considered as lower-risk alternative to smoking with mounting scientific evidence that shows reduced exposure to toxicants compared to smoking.

Unfortunately, several times, policy discussions usually are focused on the potential harms of new technology, while ignoring its potential benefits and looking at how to best use that new technology to achieve health gains:

“Debates over new technology are part of a long history of social discourse over new products. The focus tends to be on the unintended risks of new products rather than on unintended benefits.¹”

It is agreed that although nicotine is addictive, it only plays a minor role in smoking related mortality, and it has been successfully used as a medication in smoking control and smoking cessation. It is well established that the main cause leading to smoking-related diseases is the harmful chemicals that are mainly formed during the process of combustion. As stated by the FDA, the US Food and Drug Administration, “Noncombustible products, such as heat-not-burn tobacco products, smokeless tobacco, and e-cigarettes, fall somewhere in between combustible products and NRTs²”.

Smoking cessation and prevention remain the two most impactful and cost-effective interventions in medicine but have been unable to prevent the smoking epidemic. We believe that smoking control strategies should be reshaped to include harm reduction, and alternative lower risk products should be encouraged, besides the traditional smoking cessation and smoking prevention measures. There is no reasonable doubt that a variety of products are significantly less hazardous than smoking cigarettes. In the case of snus (and, thus, nicotine pouches) that risk is minimal. With vaping and HTPs the difference is also huge.

Many governmental bodies and independent researchers have conducted literature reviews or performed research on alternative to cigarettes products. Some of the key scientific findings for e-cigarettes and HTPs are referred below:

• According to the data available so far, it seems that most of the toxins in cigarette smoke are not found in e-cigarette vapor or HTPs’ aerosol and those present are at much lower levels^3-6.
• e-cigarettes: The lifetime cancer risk from vaping has been estimated to be less than 0.5% of the risk of smoking⁷.
• HTPs: Based on a study funded by the Netherlands Food and Consumer Product Safety Authority (NVWA), the researchers developed a method to estimate risk –or assess the potential magnitude of the health impact– between tobacco products. In the conclusion they stated that “the Change in Cumulated Emission (CCE) most likely amounts to a factor between 10 and 25 when comparing a leading variant of HTPs with cigarettes, and that even the lower bound of this uncertainty range would be associated with a substantial health impact in favour of HTP”⁸.

Regulatory Authorities, e.g. FDA, have issued positive decisions following consideration of the existing scientific evidence for some alternative to cigarettes products: (1) SNUS: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis⁹.” (2) HTP: “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 chemicals¹⁰.”

The SNUS case in Sweden provides the most compelling evidence that nicotine is not responsible for most of the detrimental effects of smoking¹¹. Sweden is one of the few countries globally where snus has been used for decades and smoking rates have fallen from 15% to 5.6% over the past 15 years¹², leading to lower death rates from cardiovascular disease, lung cancer, and other cancers, compared to the rest of Europe¹¹. This evidence should not be ignored or misrepresented.

If the new tobacco and nicotine products are taxed or regulated in the same way as conventional cigarettes, this will be damaging to public health and protective of the cigarette trade. Applying the same measures to all products when cigarettes are known to be far more toxic than novel alternatives will deteriorate public health outcomes.

__________________

1. Innovation and Its Enemies: Why People Resist New Technologies. Calestous Juma, Oxford University Press, 2016.
2. Nicotine Is Why Tobacco Products Are Addictive | FDA; Health Effects of Tobacco Use | FDA
3. E-cigarettes and harm reduction: an evidence review, Royal College of Physicians (2024)
4. Levels of selected analytes in the emissions of “heat not burn” tobacco products that are relevant to assess human health risks (springer.com)
5. Heated Tobacco Products: A Review of Current Knowledge and Initial Assessments – PMC (nih.gov)
6. tobaccocontrol-2018-054419.pdf (nih.gov)
7. Comparing the cancer potencies of emissions from vapourised nicotine products including e-cigarettes with those of tobacco smoke, Tobacco Control 2017
8. A Method for Comparing the Impact on Carcinogenicity of Tobacco Products: A Case Study on Heated Tobacco Versus Cigarettes – Slob – 2020 – Risk Analysis – Wiley Online Library
9. FDA grants first-ever modified risk orders to eight smokeless tobacco products | FDA
10. FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information | FDA
11. The Global Burden of Disease Study by LM. Ramström (2020)
12. Swedish snus and public health, Lakeville (2021)