The FDA Is Finally Following Its Own Science on Harm Reduction

Now that Marty Makary has departed as Food and Drug Administration (FDA) Commissioner, the agency he left behind is turning the page on his disappointing legacy. In May, while Makary was still in post, the FDA authorized four vaping products from Glas Inc.—including the first fruit flavors, mango and blueberry, ever to clear its review process. Since then, under acting commissioner Kyle Diamantas, the process has broadened. The FDA reversed its position on UniQure’s gene therapy for Huntington’s disease, accepting the clinical data it had previously rejected. It did the same for REGENXBIO’s Hunter syndrome treatment and Moderna’s mRNA flu vaccine, which the agency had refused to review earlier this year. In each case, career scientists had supported authorization. In each case, Makary’s FDA had overridden them.

The vaping story is similar. Internal FDA memos, later released by the agency itself, show that in February, reviewers concluded the Glas products were unlikely to be used by children when paired with robust digital age-verification technology. That should have meant those products could be safely sold. The authorization was nonetheless blocked by the commissioner’s office—not by career scientists.

Makary amplified alarmist rhetoric about youth vaping, notably during Senate appropriations testimony in May 2025, when he claimed there are high schools in America where students say “half of the kids” are addicted to vaping. The FDA’s own data paint a far less sensational picture. The 2025 National Youth Tobacco Survey found e-cigarette use among high-school students at 7.1 percent, down from a peak of 27.5 percent in 2019, with overall youth tobacco use at its lowest level since the survey became annual. The same federal agency that holds press conferences when those numbers rise published these results as a zip file on its website, without comment.

The FDA’s real challenge remains its inability to thwart the vast black market in unregulated vapes. Roughly 2,000 vaping products circulate in the U.S. market. Before the Glas decision, the FDA had authorized only 39—all tobacco or menthol flavored. Meanwhile, illegal imports, mainly from China, make up approximately 70 percent of the illicit market. These are smuggled products lacking basic safety standards, marketed without age verification, and freely accessible to teenagers. Makary saw the problem clearly enough—“Chinese smugglers are laughing at us,” he complained on television—but his agency’s response never matched it. Even its largest-ever seizure, 4.7 million devices last September, was a drop in a multi-billion-dollar ocean of illegal trade.

The Glas authorization demonstrates what a functioning regulatory approach looks like. These products passed rigorous toxicological evaluations, employed advanced digital age-gating systems via Bluetooth pairing with age-verified smartphones, and established clear manufacturer accountability.

The FDA’s own statements went further, explicitly labeling vaping products as “less harmful alternatives” to smoking—a crucial admission of the harm reduction potential these products hold. Around 15 million Americans are actively trying to quit smoking. Smokers who switch to vaping overwhelmingly prefer flavors other than tobacco. The FDA has now extended that logic to nicotine pouches, allowing 20 ZYN products to carry a modified-risk claim for adults who switch from cigarettes. Together with the Glas decision, it suggests the agency is finally willing to say plainly what the science shows: different nicotine products carry different levels of risk. Overly restrictive policies leave that demand intact and push it toward the black market, exacerbating the very public health risks they are intended to alleviate.

International experience confirms where prohibition leads. The UK’s recent ban on disposable vapes failed to eliminate youth vaping, merely shifting users to refillable devices or illicit channels. Australia’s prescription-only vaping model has been catastrophic, driving 90 percent of purchases underground, enriching organized crime, and triggering violent conflict—firebombed retailers and an underworld turf war over nicotine.

The early signs under Acting Commissioner Diamantas are encouraging. On May 20, the FDA warned retailers selling illegal tobacco products disguised as candy, breath strips and cough drops—rightly targeting the illicit market. The agency now needs to build on the Glas precedent: authorize more flavored products where the science supports it and spend its enforcement budget on smuggled products. Proper youth protection demands regulated and transparent markets. Prohibition and moral panic have had their time. They failed. Four authorized products is a start. The FDA’s own reviewers have been ready to go further for months. It is long past time their agency let them.

Jack Rowlett is a political commentator with Young Voices. He writes the Build Vector Substack.