In October, after years of regulatory ambiguity and antagonism toward the e-cigarette industry, the Food and Drug Administration (FDA) finally granted its first-ever authorization for e-cigarette products to be marketed and sold in the United States. While its decision should be applauded, the agency could be doing much more to promote vaping as a harm reduction measure for smokers.

While other countries — like the U.K. and Canada — have successfully integrated e-cigarettes into their tobacco harm reduction strategies, America has moved slowly to lift regulatory hurdles. Last September, more than 500 companies submitted some 6.5 million applications to the FDA seeking authorization to sell their vaping products in the U.S. market. More than a year later, after failing to meet a court-ordered deadline, the FDA has approved just three products — raising doubts about the e-cigarette industry’s legal status.

To those following the data closely, the FDA’s reluctance to recognize the public health benefits of e-cigarettes is puzzling, especially when set against the backdrop of the more than 480,000 deaths per year in the United States caused by smoking.

Numerous studies indicate that vaping is an effective smoking cessation aid. In a controlled experiment, the gold standard in scientific research, British researchers recruited about 900 smokers and randomly assigned half to use e-cigarettes and the other half to use traditional nicotine replacement products. Among e-cigarette users, 18% had stopped smoking after a year, while only 9.9% of those using nicotine replacement therapy had quit — making e-cigarettes nearly twice as effective as FDA-approved smoking cessation products.

Other studies have echoed these results, demonstrating that e-cigarettes may be the most effective weapon in the public health arsenal to curb the staggering economic and personal costs of smoking-related illness and death.

Indeed, smokers have turned to e-cigarettes in record numbers seeking a safer source of nicotine. A 2016 analysis found that one-third of U.S. smokers used e-cigarettes in their final attempt to quit, and that vaping has contributed to a 50% increase in the rate of smokers using cessation aids. According to a survey conducted from 2014 to 2016, substituting some or all combustible cigarettes with e-cigarettes was used by a greater percentage of smokers than the nicotine patch, nicotine gum, or any other cessation aids approved by the FDA.

And while e-cigarettes are not risk-free, public health authorities around the world — including the CDC — agree that they are far safer than combustible cigarettes. A 2015 report by Public Health England analyzed reams of scientific evidence and concluded: “In a nutshell, best estimates show e-cigarettes are 95% less harmful to your health than normal cigarettes, and when supported by a smoking cessation service, help most smokers to quit tobacco altogether.”

The potential benefits of encouraging smokers to transition to e-cigarettes are hard to overstate. In 2018, a team of researchers at Georgetown University Medical Center estimated that largely replacing combustible cigarettes by e-cigarettes over a 10-year period would result in up to 6.6 million fewer premature deaths in the United States — almost 9 times the U.S. death toll of the COVID-19 pandemic to date.

Critics of e-cigarettes have raised legitimate concerns about the prevalence of vaping among young people. To be sure, there are signs that the use of nicotine increases adolescents’ risk of addiction, and can make them more prone to using combustible tobacco products in the future. But restricting access to e-cigarettes may backfire. A new study from researchers at George Washington University and Stanford University found that a ban on all vaping products would cause 39.1% of young adult e-cigarette users to switch to traditional cigarettes.

Moreover, rates of teen vaping seem to be declining sharply. According to an analysis of the latest National Youth Tobacco Survey by journalist Marc Gunther, “About 11.3 percent of high school students reported vaping [in 2021], and most did so infrequently. That’s down from 19.6 percent in 2020 and far fewer than the 27.5 percent who reported using e-cigarettes in 2019.”

As some state and local governments have imposed stiff taxes and others have moved to block flavored vaping products, and as the Federal budget reconciliation bill has attempted to include a nearly 100% tax increase on vaping products, cigarette smoking in the U.S. has increased for the first time in twenty years, as vapers go “back to the pack.” Getting safe products to adult consumers is urgent and in the public’s interest.

The FDA’s foot-dragging needs to stop. Informed by the mountains of scientific research demonstrating e-cigarettes’ value as harm reduction devices, regulators should move swiftly to make them more broadly available to smokers. It is time for them to lead on this health issue.