After a Decade-Long ‘War on Vaping,’ Is the FDA Finally Embracing Tobacco Harm Reduction?

After almost a decade of conflict between the U.S. Food and Drug Administration (FDA) and the vaping industry, there are signs that America’s approach to tobacco harm reduction could be entering a different phase.

Economist Dr Raymond March, Director of FDAReview.org and a Research Fellow at the Independent Institute, recently delivered a highly critical assessment of the agency’s record on RegWatch. He described FDA policy as a sustained “war on vaping” that has restricted products, burdened independent manufacturers and contributed to public confusion about the relative risks of vaping and smoking.

Whether that characterisation is accepted or not, the FDA’s treatment of vaping has undoubtedly been contentious. But the appointment of Bret Koplow, Ph.D., J.D., as permanent director of the Center for Tobacco Products (CTP) could indicate a more pragmatic direction—one that combines strict youth protection with greater recognition of lower-risk alternatives for adults who smoke.

The roots of the saga stretch back to the FDA’s 2016 deeming rule, which extended the agency’s tobacco authority to e-cigarettes and required manufacturers to obtain marketing authorisation. The subsequent Premarket Tobacco Product Application (PMTA) process became particularly controversial. Millions of product applications ultimately received marketing denial orders, while others were left pending. Manufacturers suffered high costs, changing requirements, and uncertainty about the evidence needed to gain authorisation.

Political alarm over youth vaping, the rise and subsequent regulatory problems of Juul, and FDA prevention initiatives such as “The Real Cost” campaign further transformed vaping from a relatively small regulatory issue into a major public-health and political battle. March argues that the result disproportionately damaged independent vaping companies while favouring large corporations better equipped to absorb enormous regulatory costs.

He also criticises the FDA for failing to adequately address widespread misunderstanding of relative risk. That concern has significance beyond the vaping industry because smokers’ decisions depend partly on whether they understand that the primary danger from cigarettes comes from inhaling the products of combustion.

Independent evidence increasingly supports vaping’s role in helping smokers leave cigarettes behind. The latest Cochrane living review found high-certainty evidence that nicotine vapes produce higher smoking-cessation rates than nicotine replacement therapy, reinforcing the argument that access to regulated vaping products can have a legitimate public-health role.

The FDA’s newest leadership decision therefore deserves attention. Koplow, who had already been acting CTP director, has now been given the position permanently. According to the Department of Health and Human Services (HHS), his responsibilities will include promoting innovation and access to less harmful alternatives for adults who smoke while protecting young people from nicotine and tobacco use.

That language reflects the fundamental balance tobacco harm reduction advocates have long requested: differentiate products by risk while preventing youth uptake. More importantly, Koplow’s actions while serving as acting director suggest this may be more than rhetoric. In June, the FDA authorised 20 ZYN nicotine pouch products to carry a modified-risk claim explaining that switching completely from cigarettes to ZYN reduces the risk of several serious smoking-related diseases. Koplow said accurate information about relative harms could help adult smokers make informed decisions.

The agency had previously authorised another six nicotine pouch products through an accelerated review pilot, with Koplow explicitly describing them as lower-risk alternatives that expand options for adults who smoke.

Perhaps the most significant shift has occurred with vaping itself. In May 2026, the FDA authorised fruit-flavoured e-cigarettes for adult smokers for the first time. Rather than treating flavour and youth protection as necessarily incompatible, Koplow highlighted technology designed to prevent underage access as potentially transformative. The decision suggests a regulatory model in which innovation could address competing objectives: preserving products that may appeal to adult smokers while using technological safeguards to restrict youth access.

Koplow has also pushed for changes to the PMTA system. In May, he argued that more efficient reviews could allow products meeting the required public-health standard to reach adults who could use them to reduce their risk of premature death and chronic disease. None of this means enforcement is disappearing. Koplow has rightly taken a strong position against unauthorised nicotine products resembling candy or everyday consumer items, particularly where their design could attract children or create accidental-ingestion risks.

The emerging philosophy therefore looks less like deregulation and more like risk-proportionate regulation: facilitate scientifically supported alternatives for adult smokers while acting aggressively against products and marketing practices that threaten youth.

March’s criticism represents one side of a long-running argument over whether FDA regulation has protected public health or inadvertently protected cigarettes from competition. What happens next may prove more important than settling that historical debate.

The FDA regulates a market in which cigarettes—the most dangerous widely used nicotine product—coexist with non-combustible alternatives capable of delivering nicotine without burning tobacco. A coherent regulatory system should recognise those differences while ensuring that products intended for adult smokers do not create unnecessary risks for children.

Koplow’s appointment does not guarantee a revolution in FDA tobacco policy. But his record, combined with HHS’s explicit commitment to improving access to less harmful alternatives, provides reasons for cautious optimism. After years in which the FDA was seen as waging a “war on vaping,” the more consequential question may now be whether the agency is finally prepared to make tobacco harm reduction a central part of its strategy for ending smoking-related disease.

https://www.vapingpost.com/2026/05/17/clickbait-obsession-makarys-fda-exit-revealed-medias-preference-for-political-theater-over-science/