In a major turnaround, the U.S. Food and Drug Administration (FDA) has signalled support for tobacco harm reduction – and suggested that more flavoured vapes could soon be authorised for sale.
Speaking at the annual Food and Drug Law Institute (FDLI) Tobacco and Nicotine Policy Conference, Bret Koplow, Acting Director of the FDA’s Center for Tobacco Products (CTP), said the agency now supports “promoting a tobacco harm reduction approach to reduce cigarette smoking.”
According to veteran tobacco control expert Cliff Douglas, Koplow also “carefully supports the potential for increasing the range of flavored e-cigs that could be authorized for sale.”
Marked change in tone
The comments represent a striking departure from the FDA’s previous stance, which has seen the agency reject or delay the vast majority of applications for vaping products, particularly those in non-tobacco flavours.
To date, the FDA has authorised only a handful of devices and refills, limited to tobacco and menthol flavours. Douglas described the remarks as “refreshing and potentially groundbreaking,” while other attendees called them “a remarkable change in tone.”
Koplow also highlighted the need for a stronger, legal marketplace of authorised reduced-risk products, supported by effective enforcement.
In a post on X, Douglas wrote that Koplow “emphasizes the need for a ‘legal marketplace’ with only authorized reduced-risk products available,” but added that “to actually make this work effectively for public health purposes, [the FDA] must dramatically streamline, simplify and accelerate the review and authorization process and provide for a truly robust marketplace. Otherwise, an unregulated marketplace will thrive and these will end up being hollow words.”
Toward a regulated harm reduction model
Koplow’s comments suggest the FDA may be preparing to revise its review framework for premarket tobacco product applications (PMTAs), a process criticised by both industry and public health experts for its complexity and slow pace.
Koplow indicated the agency would soon issue new guidance outlining how it evaluates risk across nicotine and tobacco products, and indicated that flavoured products using strong age-verification controls could meet public health standards.
Industry observers, including Chris Allen, who leads the UK harm reduction consultancy Broughton, said the remarks mark the FDA’s first public acknowledgment in years that harm reduction could be embedded within its regulatory structure.
Writing on LinkedIn and in comments to Nicotine Insider, Allen said: “This was more than a language shift. It was a reframing of how CTP interprets the ‘appropriate for the protection of public health’ standard at the heart of the Tobacco Control Act.”
Broader implications
Experts say the shift could have far-reaching consequences for the global tobacco and nicotine market. The FDA’s regulatory approach has often shaped international standards, and a move toward authorising flavoured vapes could influence European and UK discussions on risk-proportionate regulation.
For now, however, questions remain over how far and how quickly the agency will act. The FDA has issued dozens of marketing denial orders (MDOs) in recent years, and critics warn that meaningful change will depend on whether new policies are followed by real regulatory flexibility.
Still, the agency’s change in tone – from outright restriction toward harm reduction – may mark the beginning of a new era in U.S. nicotine policy, and one that global regulators will be watching closely.
