FDA’s Anti-Vape Stance Helps Chinese E-Cigs Thrive
Like Prohibition, today’s tobacco regulators are creating a massive black market.
Esco Bars is the new “bathtub gin.” A century on from alcohol prohibition and the same spirit that couldn’t kill spirits is failing against unregulated e-cigarettes. And just as the absence of sanctioned distillations made room for moonshine and rot gut, domestic vapes are being supplemented (to put it mildly) by products that are cheaper to make and more potent. But this time around, we don’t need a constitutional amendment to tackle the problem created by the last constitutional amendment.
Instead, we need the Food and Drug Administration (FDA) – specifically its Center for Tobacco Products (CTP) – to use its budget and do its job (with a little help from Border Patrol, but more on that later). The FDA was given jurisdiction over e-cigarettes in 2016. E-cigarettes and other vapes have been marketed as a healthier alternative to smoking – delivering nicotine without tar and some other byproducts of tobacco. They have helped many smokers quit and are therefore considered a harm-reduction tool.
Enter the bureaucracy. To sell new tobacco products in the U.S., companies must file a “premarket tobacco application” (PMTA) and receive a “marketing granted order” (MGO) from the FDA. The “user fees” companies pay the FDA are supposed to cover the cost of the research and testing FDA does on products. It should be a straightforward process.
“The center has received applications for more than 26 million deemed products since 2020,” CTP Director Brian King recently boasted, “and has made determinations on 99 percent of these applications.”
But the CTP has approved a shockingly low number of PMTAs. According to an October 2023 New York Times report, “of the 2,000 or so vaping and e-cigarette products on the market, the agency has only given the green light to about two dozen of them, and it still has to deal with a backlog of applications.” According to the CTP’s own figures, it approved three in 2023, 20 in 2022, seven in 2021, and one in 2020. In 2021, the FDA was ordered in court to process all its applications. It still hasn’t.
Resources can’t be the problem. In FY 2023, for example, the CTP took in $677 million! Given that processing PMTAs is one of the office’s primary duties, to approve only three in a year makes $1,000 hammers and $600 toilet seats look like a bargain.
Where exactly CTP spends all these user fees is not public knowledge, but what is becoming clear is the boon prohibition-by-inaction is for black-market products. While overall youth e-cigarette use has been trending down significantly recently, illicit brands are flooding the market and marketing directly to minors. Next time you’re in a convenience store, note how many vaping products are available. Many found may not be legal for sale in the U.S., and 90% of them originate in China. A large proportion enter through our southern border, courtesy of Mexican drug cartels (also true of fentanyl and other opioids, to far more devastating effect). It’s also rumored that illicit vaping contraband is subsidizing the likes of Hamas and Hezbollah as well. Just as fortunes were made during liquor prohibition, there’s money to be made from bootleg e-cigarettes. Lax border enforcement brings in more than illegal immigrants.
Ironically, CTP may be spending most of its resources fighting the problem that its inaction on PMTAs has created. Last September, the FDA fined 22 gas stations for selling Elf Bar vapes, a product that largely targets minors. The CTP may be making the problem worse yet. Against the 31 PMTAs approved over the past four years, the CTP has issued more than 280 market denial orders (MDOs) essentially denying companies that submit thousands of pages of data and spending extensive resources to comply with public regulators’ constantly shifting goalposts. The FDA claims it processed 99% of the 26 million applications, so it means there’s been only about a one-in-a-million chance an application is approved.
With government dysfunction, sunlight must be part of the solution. Indeed, many retailers are willing to risk fines because of the uncertainty and lack of transparency. The Energy Marketers of America, representing gas station stores, filed a petition with the agency demanding clarity about what’s legal to sell. My group, the Functional Government Initiative, has also submitted several information requests trying to understand the gray zone in which so many PMTAs linger. Alas, the CTP and the FDA have often met our requests with silence and confusion.
Perhaps no vapes should be legal in the United States. Today’s prohibitionists are free to make their case. But until prohibition is the law of the land, the FDA has a job to do. The e-tobacco regulatory process is obviously dysfunctional. Government employees putting fingers on the scale will only make it more so.
Pete McGinnis is the Communications Director for the Functional Government Initiative (FGI).
