We all know that smoking kills, and many smokers know that switching to vaping is the best way to get their nicotine fix without the cancer risks of burning tobacco. The UK government is so convinced that vaping is the best off-ramp from smoking that they’ve sent vaping kits to more than a million smokers.
But the U.S. regulator—the Food and Drug Administration—has failed to give regulatory approval to the vaping products consumers want. The result has been an influx of illicit Chinese products of uncertain quality. In a recent analysis of vaping packs discarded in several U.S. states, 97% were illegally imported.
Are these products available only in illicit markets, or are they available in major retail outlets?
For my latest research, I interviewed the owners of 14 of those legal retailers: gas stations in the Philadelphia suburbs. I found a total of 459 vape products, with each retailer selling at least 100 brands. Two brands—Elf and Lost Mary, both made by the Chinese company ShenzhenIMiracle—dominated the market. More than 30 different Elf and Lost Mary flavors were available, including blueberry, kiwi, watermelon and cherry.
Of the 459 vape products on these retailers’ shelves, only three tobacco or menthol-flavored products, made by Vuse, were approved by the FDA. A couple of Juul products are in a kind of legal limbo. That leaves 454 brands, or 99% of the market, that are illegal. Sales of these illegal vapes have gone from a few hundred dollars a month to more than $10,000 a month.
This is astonishing and it’s not limited to the Philadelphia suburbs. Gas stations up and down the I-95 corridor sell similar products, often with different brands from within the same brand group. Geek Bar was the best seller in Maryland and D.C., whereas it was Elf Bar in Pennsylvania and Lost Mary in New York City.
Why Are Unapproved Products Sold in Otherwise Legal Businesses?
The store managers I interviewed were not sure which of the products they sell are legal. They assume their suppliers operate legally and undertake due diligence.
One manager said that, while he obviously didn’t want to “break the law,” demand for vaping products is significant, there is no “strong guidance on illegality” and ”so, I’ll keep selling them until I’m told not to and that is enforced.”
Distributors and retailers should obey the law, but is it their fault they’re not? As leading tobacco-regulation analyst Clive Bates put it, the FDA has created “almost insurmountable regulatory hurdles and barriers to entry for vapes.” The FDA’s strict legal sanction on U.S. vape pioneer and previous market leader Juul, which prevented it from selling flavored products, was not followed up with further significant action against manufacturers or retailers that sell similar products from companies based outside the United States.
Manufacturers have tried to comply with the FDA rules, but the agency has changed its mind repeatedly on what manufacturers must demonstrate, with the obvious aim of denying new products. Some have ultimately resorted to litigation. In a recent decision, the 5th U.S. Circuit Court of Appeals ruled against the FDA on grounds that its decisionmaking processes to approve vaping products are “arbitrary and capricious.”
The FDA is currently seeking a U.S. Supreme Court ruling on its decisionmaking process but, in the meantime, the legal limbo continues. FDA is effectively handing quality control over vaping products to China, where most of the finished vaping products, hardware and e-liquids are produced. While Chinese authorities have little interest in the quality of products exported to the United States, Chinese companies want repeat business and therefore have an incentive not to harm U.S. users. And it should be noted that many of the larger brands, such as those made by ShenzenIMiracle, have passed UK quality rules.
But Chinese quality control is weak in pharmaceutical production, even when FDA has some oversight. The possibility of a lethal accident from Chinese-made vaping products is not negligible. After all, illegal cannabis vapes made with e-acetate caused the death of 68 Americans in 2019 and 2020.
Given that the alternative to vaping is usually smoking, U.S. public policy should encourage vaping products manufactured to a high standard and marketed exclusively to adults. That means establishing and enforcing clear, objective, and reasonable quality standards that would apply to all vapes on the market, as the UK has done, and not imposing arbitrary and capricious requirements on vape manufacturers and importers, as the FDA has done. It’s time for the FDA to do its job, approve good quality products, and let a regulated market develop.
Roger Bate is a nonresident scholar at the International Center for Law & Economics (ICLE).
