Category: News This Week

By Professor Praneet Valodia, Director Praneet Valodia Consulting

I am a healthcare professional. I have chaired Drugs and Therapeutics committees, evaluated clinical trials for over two decades and been at the forefront of innovation in therapeutic technologies. With that experience comes a responsibility to speak when evidence is ignored. What I cannot do and will not do is remain silent in the face of flawed thinking, especially when it affects public health.

South Africa is on the verge of adopting a new Tobacco Bill. In its current form, this legislation treats combustible cigarettes and non-combustible nicotine-containing products as the same. That is a serious problem. The science says they are not the same, and pretending otherwise undermines the very goals we are trying to achieve in public health.

I have independently evaluated the vast data I recently presented to the Health Portfolio Committee using standard criteria that are applied in assessing scientific studies. I have used this same approach in evaluating new drugs and health innovations. When applying it to tobacco harm reduction, the evidence is clear: switching from combustible cigarettes to non-combustible alternatives significantly reduces harm.

The combustion of tobacco produces between 6,000 and 7,000 chemicals. Among these, around 100 are harmful or potentially harmful. Non-combustible nicotine-containing products produce no combustion and 60 to 99 percent fewer harmful chemicals¹. This is based on an independent evaluation by the United States Food and Drug Administration (U.S. FDA), a leading authority in tobacco and medicines regulation. Nicotine levels are the same but nicotine is not the harmful substance. It’s the other chemicals, nitrosamines and polycyclic aromatic hydrocarbons, etc. which cause disease.

The U.S. FDA evaluation of a heat-not-burn technology showed reductions of 82 percent in carcinogens, 91 percent in respiratory toxicants and 94 percent in reproductive toxicants compared to combustible cigarettes. Heavy metals that are classified as carcinogenic to humans, such as nickel, chromium, cadmium and lead, were either undetectable or drastically reduced in these products^1-3.

As an example, an evaluation of an E-cigarette by the U.S. FDA showed a 65 to 100 percent reduction in harmful chemicals compared to combustible cigarettes. Abuse liability is lower, and lab studies show no mutagenic, cytotoxic or genotoxic effects⁴.

The Cochrane Collaboration’s 2024 report, based on randomised trials in multiple countries, found nicotine e-cigarettes showed significantly greater efficacy than nicotine replacement therapy for smoking cessation. Safety profiles are similar between nicotine e-cigarettes and nicotine replacement therapy⁵. Similarly, a study by Hajek et al.⁶ published in the New England Journal of Medicine a randomized trial that showed 18 percent abstinence at 52 weeks for E-cigarettes versus 9.9 percent for nicotine replacement therapy.

Risks of myocardial infarction, stroke and Chronic Obstructive Pulmonary Disease (COPD) are reduced by 52, 35, and 54 percent respectively with vaping versus smoking⁷.

Sweden’s experience with snus shows dramatically lower lung cancer and cardiovascular death rates, three times lower than the European Union, where snus is banned. This is evidence that tobacco harm reduction saves lives⁸.

Nicotine is addictive but not toxic at the doses used in these products. Nicotine toxicity depends on dose. It can be toxic if injected or ingested in large amounts but aerosolised nicotine in these devices is considered to be safe. Nicotine is not carcinogenic⁹ nor does it cause heart or lung disease, according to current evidence^7,10.

Claims that vaping acts as a gateway to smoking are also unsupported¹¹. I have looked at numerous studies and could not find evidence that vaping is a gateway to smoking. We must base decisions on scientific evaluation of the gateway theory to smoking.

South African youth smoking prevalence is very low at 2.08 percent¹² and that should be celebrated. Smoking prevalences in youth is low in many countries although non-combustible nicotine-containing products are freely available.  This may indicate the non-combustible nicotine-containing products are not a gateway to smoking. We need to understand the addictiveness of nicotine relative to other substances, like alcohol and cannabis.

The current tobacco bill fails to differentiate combustible cigarettes from non-combustible products despite this overwhelming evidence. I have a moral obligation to provide smokers with evidence-based options — safer alternatives.

We must adopt a regulatory framework like the FDA’s, which weighs benefits and risks for the population, including youth and vulnerable groups, based on the net benefit to public health.

The way forward is not to abandon regulation. It is to regulate more intelligently. We need to differentiate products based on harm, just as the FDA does.

We need good policies and these policies need to be evidence-based. We need consistency in decision-making relative to other substances such as cannabis. We need an independent scientific committee to evaluate the evidence and the reports should be made publicly available. Given the volume of misinformation, establishing an independent scientific committee is not just important. It’s essential.

The bill needs to be transformative and including tobacco harm reduction is a key part of that. We need penalties that are proportionate. And we must protect the autonomy of people trying to quit smoking by giving them access to safer alternatives.

The focus of tobacco harm reduction should be on the 11.5 million smokers in South Africa. This is where the public health problem is. We need a paradigm shift. We must include tobacco harm reduction in the bill or condemn millions to preventable death and disease.

Ignoring this evidence is unconscionable.

References

1. U.S. FDA: Scientific Review of Modified Risk Tobacco Product Application (MRTPA) under Section 911(d) of the FD&C Act – Technical Project Lead – 5/12/2016.
2.  U.S. FDA Briefing document, Meeting of the Tobacco Products Scientific Advisory Committee, January 24-25, 2018.
3. U.S. FDA: Scientific Review of Modified Risk Tobacco Product Application (MRTPA) under Section 911(d) of the FD&C Act – Technical Project Lead – 7/7/2020.
4. U.S. FDA: Technical Project Lead (TPL) Review of PMTAs. NJOY. 2020.
5. Lindson N, Butler AR, McRobbie H, Bullen C, Begh R, Theodoulou A, Notley C, Rigotti NA, Turner T, Livingstone-Banks J, Morris T, Hartmann-Boyce J. Electronic cigarettes for smoking cessation (Review). Cochrane Database of Systematic Reviews. 2024.

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010216.pub8/full.

6. Hajek P, Phillips-Waller A, Przulj D, Pesola F, Smith KM, Bisal N, Li J, Parrott S, Sasieni P, Dawkins L, Ross L, Goniewicz M. et al. et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. N Engl J Med. 2019; 380:629 -637.

https://www.nejm.org/doi/full/10.1056/nejmoa1808779

7. Lee PN, Farsalinos K. Comparing smoking-related disease rates from e-cigarette use with those from tobacco cigarette use: a reanalysis of a recently-published study. Harm Reduction Journal. 2025; 22: 78. 
8. Smoke Free Sweden. No Smoke Less Harm. 2024.
9. International Agency for Research on Cancer. WHO. List of classifications by cancer sites with sufficient or limited evidence in humans, IARC monographs Volumes 1-139.
10. Balfour DJK, Benowitz NL, Colby SM, et al. Balancing consideration of the risks and benefits of e-cigarettes. Am J Public Health. 2021; 111(9):1661–1672.
11. Polosa R, Casale TB, Tashkin DP. A close look at vaping in adolescents and young adults in the United States. J Allergy Clin Immunol Pract. 2022; 10(11):2831-2842.  
12. Van Zyl-Smit RN, Filby S, Soin G, Hoare J, Van den Bosch A. Kurten S.  Electronic cigarette usage amongst high school students in South Africa: a mixed methods approach. eClinicalMedicine. 2024; 78:102970.