As South Africa continues to debate the regulation of combustible tobacco and non-combustible nicotine products through the proposed Tobacco Products and Electronic Delivery Systems Control Bill, a significant global regulatory shift is unfolding in the United States, one that could offer important lessons for local policymakers, healthcare professionals and public health stakeholders.
There was a shift in viewpoint at the recent 10th Annual Nicotine Summit US 2026, held in Washington, D.C., where Dr. Bret Koplow, Acting Director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), delivered what many observers are viewing as opening up further opportunities to build a regulatory framework that incorporates guidance for flavoured e-cigarettes. It should be noted that the FDA has already authorized for sale products that are categorised as e-cigarettes, heated tobacco products, snus and nicotine pouches. These products are collectively referred to as non-combustible nicotine products. At this summit scientists, regulators and public health experts gathered to discuss the evolving role of non-combustible nicotine products.
The timing of the summit was especially significant.
Just days earlier, the FDA authorised the sale of certain fruit-flavoured e-cigarette products for the first time in its history, marking a major departure from years of resistance to non-tobacco flavoured vaping products. The agency described the move as an expansion of market access for adult smokers while maintaining safeguards against youth uptake.
Crucially, the products authorised by the FDA included age-gating which is advanced access-restriction systems requiring government ID verification, smartphone pairing and ongoing authentication measures intended to prevent underage use.
Koplow described these access-restriction technologies by youth as a “potential game changer” because they could allow regulators to evaluate certain flavoured products differently if robust youth-access controls are in place.
Importantly, the FDA has not said flavours are now freely permitted. Rather, the agency appears to be signalling that flavoured products may become more acceptable where manufacturers can scientifically demonstrate both adult benefit and credible youth-protection mechanisms. This distinction is critical and represents a potentially major recalibration in global tobacco regulation.
Notably, the FDA is increasingly focusing its enforcement resources on products seen as posing the greatest public health concerns, particularly illicit imports, counterfeit products and products designed to appeal to children.
For years, the FDA has largely been associated with strict controls on non-combustible nicotine products including flavoured vaping products. Yet Koplow’s keynote suggested a noticeable evolution in thinking: one that places far greater emphasis on a differentiated regulatory policy based on the huge difference in risk between combustible and non-combustible nicotine products. Koplow said during his address “Combustible products, especially cigarettes, are the most harmful,” while “non-combustible products such as e-cigarettes and nicotine pouches generally pose lower health risks than cigarettes.”
Historically, many health authorities have been reluctant to publicly differentiate between combustible cigarettes and non-combustible nicotine products. But the FDA recently again acknowledged that regulating combustible cigarettes and non-combustible nicotine products differently will produce the best public health outcomes, by switching adults smokers to non-combustible nicotine products. If smokers are not switched then they will continue smoking cigarettes considering the high failure rate of quit attempts. Koplow addressed this directly. “For some, completely switching to a lower-risk FDA-authorised product can increase the likelihood of living a longer, healthier life,” he said. At the same time, he repeatedly stressed that quitting all tobacco and nicotine products remains the best health outcome.
Another notable theme emerging from the summit was the importance of accurate public education around the much-reduced comparative risk of non-combustible products relative to combustible cigarettes.
Koplow warned that many smokers incorrectly believe that non-combustible nicotine products are equally or more harmful than cigarettes, a misconception he suggested may discourage smokers from switching away from combustible tobacco altogether.
He also acknowledged that many healthcare professionals remain insufficiently informed about comparative risk between combustible cigarettes and non-combustible nicotine products. “Some mistakenly believe nicotine itself is a carcinogen,” he said.
For South Africa, where smoking-related diseases continue to place enormous strain on the healthcare system, these conversations may become increasingly difficult to avoid.
This debate is highly relevant for South Africa.
South Arica’s Tobacco Products and Electronic Delivery Systems Control Bill, first introduced in 2018, remains in legislative limbo after years of delays. The draft Bill proposes sweeping restrictions across combustible cigarettes and non-combustible nicotine products. The draft bill also includes stricter public smoking rules, plain packaging, etc. Yet one of the biggest unresolved questions remains whether South Africa’s regulatory framework sufficiently will distinguish between combustible cigarettes and the lower-risk non-combustible nicotine products like the FDA.
South Africa faces unique challenges, including a significant illicit cigarette market, differing healthcare realities and enforcement constraints. However, the developments emerging from Washington D.C. suggest that global tobacco regulation may be entering a new phase towards a more evidence-based approach that considers differentiation between combustible cigarettes and non-combustible nicotine products, consumer behaviour and innovation. There is sufficient evidence to also demonstrate that e-cigarettes are more effective for smoking cessation compared to nicotine replacement therapy (NRT) and equally as safe as NRT (Cochrane Collaboration, 2025).
Some countries continue pursuing highly restrictive approaches to non-combustible nicotine products. Others, including the United States, Sweden and the United Kingdom, have increasingly incorporated the concept of tobacco harm reduction into public health discussions. Notably, Argentina has just repealed vape prohibition after 15 years. A significant stride. It was stated that their Ministry of Health has replaced ideology with evidence and rationality.
As South Africa’s tobacco legislation inevitably returns to the spotlight, the FDA’s latest direction may become an increasingly influential part of that conversation.
Written by Professor Praneet Valodia, Director Praneet Valodia Consulting