There is a built-in incentive for regulators like the Food and Drug Administration to be cautious. Saying no rarely begets significant backlash. Saying yes means owning every negative headline for the next decade or more. So when the FDA does say yes, it’s worth paying attention.
Recently, the agency authorized new e-cigarette products, citing data showing nearly 20% to 35% of adult smokers using the tobacco-flavored pod had stopped smoking cigarettes entirely at six weeks. For the menthol pod, roughly 28% to nearly 50%.
And while it should be intuitive that vaping means lower exposure to harmful chemicals than setting tobacco on fire, the data confirmed that as well for adults who switched to vaping completely.
Critics of the authorization point out that the FDA didn’t approve these devices specifically as smoking cessation products. While that is true, that wasn’t what the agency was testing. Rather, the agency was evaluating whether to allow the makers of the e-cigarette products to market them as beneficial for public health.
The test was created by Congress in the Family Smoking Prevention and Tobacco Control Act of 2009. A new tobacco product can earn a marketing order if the applicant demonstrates that permitting its sale is “appropriate for the protection of the public health.” It’s a cost-benefit analysis, weighing the upside for adults who switch away from cigarettes against the risk of creating new vapers who would not otherwise use nicotine. FDA scientists applied that test and published the numbers.
The agency took its time — 615 days to be exact, more than three times the 180-day deadline that Congress gave the FDA to complete Premarket Tobacco Product Application reviews. It’s hard to chide scientists for being thorough, but there are real downsides to the delay. While companies seeking the legal route were stuck in limbo, billions of dollars worth of illicit vapes flooded store shelves across the country.
Vaping has fervent critics, and many predictably blasted the agency’s decision. The FDA “should be cracking down on products that hook kids on nicotine,” said Rep. Raja Krishnamoorthi (D-IL)
But missing from that knee-jerk reaction is any rebuttal to the agency’s scientific findings or methods. It can be politically advantageous to tap into public anxieties over youth vaping, but that is not a reasoned argument about the products the agency reviewed or its process. Members of Congress are entitled to their views and press releases, of course. But the people’s representatives enacted a law, and the FDA implemented it. Without evidence that the agency erred in its review, there should be no cause for alarm.
There is also good news on the youth vaping front. E-cigarette use among middle and high school students fell to 5.2% in 2025, part of what the FDA calls historic lows across tobacco products. If the FDA can authorize products that help adults quit smoking while continuing to preside over a reduction in youth usage, policymakers should celebrate that outcome while remaining vigilant.
Trust in public health authorities has declined in recent years, and commenters across the ideological spectrum have decried attempts to politicize what should be evidence-driven processes. If we want Americans to trust “the science,” it is unproductive for elected officials to pressure agencies into reversing scientific findings based on politics rather than data.
The fact is, cigarettes still kill more than 480,000 Americans every year, and there is a need for safer off-ramps. Of the 6,000-plus e-cigarette products on the U.S. market as of June 2024, most are made in China, sneaked past customs, and were never authorized for legal sale. Retail scanner data put unauthorized products at 86.3% of sales. But the Justice Department managed only 88 enforcement actions across four fiscal years, suggesting a need for greater emphasis from legal authorities or more funding from Congress.
ANTI-VAPING HYSTERIA KEEPS SMOKERS HOOKED. TRUMP’S FDA IS (FINALLY) EMBRACING REALITY
It illustrates why an efficient review pathway for legal products is so important. The Trump administration has been digging out of a massive backlog of e-cigarette applications that piled up for years. Last week’s announcement brings the total number of e-cigarette authorizations to just four dozen. That is progress, but more action is needed to curb the black market’s advantage over legal products.
Regardless, the FDA got it right with its recent authorizations, and the decisions should be recognized as good policy. The agency applied the statutory test and published findings to show why the products met the standard. It may have taken too long, but the agency ultimately reached a conclusion backed by evidence. Let’s hope to see more of that going forward.
Evan Swarztrauber is Principal at CorePoint Strategies, a technology and telecommunications policy firm.