FDA Vaping Rules: Much Ado About Very Little

During his tenure as secretary of the U.S. Department of Health and Human Services, Robert F. Kennedy Jr. has promoted a Make America Healthy Again agenda that at times reminds me of the worst overreach of progressive nannies. The Cato Institute, musing on last year’s MAHA report card, rightly worried that it “risks turning scientific inquiry into propaganda and personal health into political theater.” Leftists have always done this, too, but that only reinforces my concern about having the federal government — whichever party happens to run it — play such a dominant role in health policy.

So I was at first encouraged to see new draft guidance from the U.S. Food and Drug Administration — an agency that resides within HHS — that takes a seemingly non-theatrical approach toward one of the nation’s ongoing health concerns: vaping. The comment period is still open, but the proposal signals a slight shift away from the usual emotion-laden propaganda that public-health activists use to continue their anti-vaping policies. Upon closer examination, however, it doesn’t really move the needle.

Nevertheless, the headline from Stat News captures the predictable, overheated reaction from health activists: “FDA move on flavored vapes rattles public health experts.” The New York Times put a political spin on the announcement: “The Trump White House views vaping as an election issue, with many MAGA voters embracing e-cigarettes and President Trump having promised during the campaign season to ‘save vaping again.’” That’s strange because the proposal hardly heralds the kind of policy shift that will affect election results.

Various states (especially liberal ones such as California) and many local governments have been banning the sale of flavored-tobacco. They define products that contain nicotine but not tobacco as “tobacco” in order to fold them into existing tobacco control measures. This means bans on the sale of flavored vapes, as well as bans on flavored nicotine pouches such as Zyn. Their argument is flavors encourage teens to get hooked on these products, even though it’s illegal for people under 21 to buy them. The FDA likewise has withheld its approval of products with flavors, citing similar logic.

The counter argument is that vaping, per the British public-health agency, is 95 percent safer than cigarette smoking. Those pouches are even safer. (One cited reason Sweden has the lowest cancer rate in the European Union is that men there in particular are accustomed to using tobacco pouches called snus rather than smoking cigarettes.) Removing vapes and pouches from store shelves makes it harder for smokers to choose lower-risk products. And studies show smokers cite the availability of flavors as an enticement to make the switch.

So the public policy issue comes down to a tradeoff, per the FDA report: “[Vaping] products with fruit and candy/dessert/other sweet flavors that appeal to youth pose a substantial public health risk. Given the substantial public health risks these products pose to American youth, these products face a correspondingly high evidentiary burden to demonstrate that the benefits to adult smokers in terms of quitting or significantly reducing cigarette use outweigh the risks of youth initiation and use.” It notes that youth vaping has declined significantly since 2019, leaving many of us wondering the degree to which it poses a health “crisis.”

I’d argue that adults should be free to buy the adults-only products they choose, while governments should stick to enforcing the law to assure that minors cannot easily access them. It seems odd to ban products under the thinking that they are appealing to people who aren’t even legally allowed to buy them, even if we all agree that it’s a bad trend if young people are drawn to addictive substances. But that’s the state of public health policy these days.

The FDA’s draft guidance from last month shouldn’t rattle anyone, as it still takes a more cautious approach than the evidence requires. It would continue to oppose the sale of fruity, sweet, and candy flavors that appeal to young people while possibly allowing the sale of mint, spice, and coffee flavors that appeal to adults. Manufacturers would still face a long, costly, and bureaucratic federal process to get approval, without any guarantee adult consumers would choose spice or coffee flavors over illicit ones.

As Stat News added, “If manufacturers want flavors like these approved, they would have to show the agency that those flavors are both more likely to get adult smokers to switch over to e-cigarettes than tobacco flavors, and that the benefits to adults ‘outweigh the added risk to youth.’” That the public health community views this as a radical assault on America’s youth speaks poorly about their unscientific outlook.

A couple of final points. First, as I reported for The American Spectator in 2024, Yale researchers looked at the impact of San Francisco’s flavored vaping ban: “After the ban’s implementation, high school students’ odds of smoking conventional cigarettes doubled in San Francisco’s school district relative to trends in districts without the ban, even when adjusting for individual demographics and other tobacco policies.” So even this new and improved FDA guidance misses evidence that flavor bans don’t necessarily stop teens from vaping — and perhaps it’s the reverse..

Second, as my R Street Institute colleague and public health expert Jeffrey Smith recently explained last month, the FDA’s refusal to authorize a significant number of e-cigarette products has created the situation whereby “an estimated 54% of vape products on U.S. retail shelves are unauthorized and illegally distributed.” These tend to be “cheaply manufactured disposables” mainly imported from China “without any regulatory oversight.”

If the FDA, the states and locals made it easier to sell “scientifically reviewed, legally authorized” cigarette alternatives rather than clamping down on them, then it would create a safer marketplace. But that would mean an FDA that spent less time meddling in the private decisions of adults and stuck to enforcing prohibitions on minors. Despite the ensuing hysteria, the FDA’s latest action sounds like a forward step, but really is more of the same heavy-handed regulatory malfunction. So much for a sea change in policy from HHS.